Abstract
Background
Colectomy is a common procedures for both benign and malignant conditions. Increasingly more colectomy has been performed laparoscopically and there are several available instruments being used for this procedure. Of which three common dissecting instruments are: monopolar electrocautery scissors (MES), ultrasonic coagulating shears (UCS) and electrothermal bipolar vessel sealers (EBVS).
Objectives
The aim is to assess the safety and effectiveness of these instruments.
Search methods
Studies were identified from PubMed, EMBASE, Cochrane Controlled Trials Register, Cochrane Colorectal Cancer Group Trials Register. Major journals were specifically hand searched. All randomised controlled trials were included.
Selection criteria
All patients underwent elective laparoscopic or laparoscopic‐assisted right, left or total colectomy or anterior resection for either benign or malignant conditions were included in the study.
Data collection and analysis
Two reviewers independently selected studies from the literature searches, assessed the methodological quality of the trials and extracted data. The three primary outcomes were: overall blood loss, complications and operating time.
Main results
Six randomised controlled trials including 446 participants. Two trials compared three types of instruments (MES vs UCS vs EBVS). One trial compared MES and UCS. One trial compared UCS and EBVS. One trial compared 5 mm versus 10 mm EBVS. One trial compared the technique of laparoscopic staplers and clips versus EBVS in pedicle ligation during laparoscopic colectomy. The limitation of this review is the heterogeneity of the trials included. The measured outcomes were covered by one to three studies with small number of participants. With this in mind, there was significant less blood loss in UCS compared to MES. The operating time was significantly shorter with the use of EBVS than MES. No difference between UCS and EBVS apart from EBVS appeared to be handling better than UCS in one study. Haemostatic control was better in UCS and EBVS over MES. No definite conclusion on the cost difference between these three instrument but this would lie in the balance between the instrument cost and the operating time. The handling of 5 mm EBVS was better than 10 mm and its main advantage was trocar flexibility. Laparoscopic staplers/clips used for pedicle ligation in colectomy associated with more failure in vessel ligation and cost more when compared to EBVS.
Authors' conclusions
The limitations of this review is the small number of trials and heterogeneity of the studies included. With the current evidence it is not possible to demonstrate which is the best instrument in laparoscopic colectomy. Hopefully more data would follow and subsequent updates of this review could become more informative.
Keywords: Humans; Blood Loss, Surgical; ; /adverse effects; /instrumentation; /methods; Electrocoagulation; Electrocoagulation/adverse effects; Electrocoagulation/instrumentation; Laparoscopy; Laparoscopy/methods; Ultrasonic Therapy; Ultrasonic Therapy/adverse effects; Ultrasonic Therapy/instrumentation
Plain language summary
Different types of energy source surgical instruments used in key‐hole bowel surgery
Having a laparoscopic (key‐hole) approach in surgery to remove a section of a diseased bowel, either caused from a benign or cancerous lesion is becoming increasingly common. There are three kinds of surgical instruments available for this procedure; these are monopolar electrocautery scissors (MES), ultrasonic coagulating shears (UCS) and electrothermal bipolar vessel sealers (EBVS). This review aims to examine the effectiveness and safety of these three instruments. The findings showed that UCS results in less blood loss when compared to MES. Operating time was shorter when EBVS was used compared to MES. No marked difference was observed between UCS and EBVS. No difference in complications between all three instruments were reported in the findings. However, it is recognised that more trials are needed to support the evidence provided in this report.
Background
Description of the condition
Colorectal cancer is one of the most common cancers in the western world. The main treatment option remains surgery though other treatment modalities include chemotherapy and radiotherapy (Cancer Research UK 2008). Apart from treatment of cancer, colectomy (surgical removal of diseased bowel) is also performed in benign conditions such as inflammatory bowel disease, diverticular disease and familial adenomatous polyposis. The traditional approach for colectomy is through an open approach where a long midline incision is often employed. Laparoscopic colectomy is being increasingly utilised since its introduction in the early 90s (Falk 1993). It’s short‐term results compare favourably to the open approach in terms of post‐operative pain, pulmonary function, duration of ileus and hospital stay (Abraham 2004; Schwenk 2005). Laparoscopic colectomy demands complex surgical techniques and requires a deep learning curve. However, advances in laparoscopic instruments have made these complex operations more feasible.
Description of the intervention
There are three common dissecting instruments currently used for laparoscopic colectomy: monopolar electrocautery scissors (MES), ultrasonic coagulating shears (UCS) and electrothermal bipolar vessel sealers (EBVS). MES employs the basic principle of electrosurgery, using high frequency alternating current (about 500 kHz) to provide cutting or coagulating effect (Hay 2008). UCS (e.g. Harmonic ScalpelTM; Ethicon Endo‐surgery, Cincinnati, OH, USA) involves high frequency (55,000 cycles/s Hz) vibrating blades that denatures hydrogen bonds in tissue and vessel proteins, forming a coagulum that seals the vessels. It is shown to be safe for sealing vessels up to 5 mm in diameter (Person 2008). EBVS (e.g. LigaSureTM; Valleylab, Boulder, CO, USA) employs a high current (4 A) and low voltage (<200 V) setting. When the forceps are closed on to tissues, its energy denatures the collagen and elastin in the vessel wall allowing protein to form a seal. Studies have shown that EBVS is capable of sealing vessels with diameter up to 7 mm (Campbell 2003; Harold 2003). Other less commonly used energy source instruments include Gyrus Plasma TrissectorTM (Gyrus ACMI, Maple Grove, MN, USA), which is another type of bipolar vessel sealer, and a device using nanotechnology EnSealTM (SurgRx, Redwood City, CA, USA) (Lamberton 2008; Newcomb 2009).
How the intervention might work
Compared to the traditional MES, both UCS and EBVS can provide simultaneous cutting and coagulation. Therefore fewer instrument exchanges are required during operation. They also produce less smoke and may therefore improve visibility and reduce cleaning time. All of these advantages may translate into effective and safer surgical dissection and patient outcome.
Why it is important to do this review
Advances in laparoscopic instruments are allowing complex surgical manoeuvres to be possible. Two comparative studies have examined the efficacy and safety of different energy source instruments (Campagnacci 2007; Takada 2005). However, there is no systematic review comparing these instruments in laparoscopic colectomy. Laparoscopic colectomy does not rely solely on surgical skills but the utility and safety of equipments. For this reason it is important to critically appraise the energy source instruments that are currently in use. This review may help to guide surgeons by informing them of the appropriateness of instruments and allow for any surgical needs and specifications to be further clarified.
Objectives
To evaluate the advantages and disadvantages of different types of energy source instruments during laparoscopic colectomy including safety, speed, intra‐operative complications and handling.
Methods
Criteria for considering studies for this review
Types of studies
All randomised studies which have undergone a peer review process will be included in the review. Trials reported in abstract form will only be included if there is sufficient data.
Types of participants
All patients underwent elective laparoscopic or laparoscopic‐assisted right, left or total colectomy or anterior resection for either benign or malignant conditions will be included in the study. Anastomosis may have been performed intra‐corporeally (inside the abdomen) or extra‐corporeally (outside the abdomen) with either staple‐ or hand sewn‐ anastomosis or combination of both.
Types of interventions
Monopolar electrocautery scissors (MES) vs ultrasonic coagulation shears (UCS) vs electro‐thermal bipolar vessel sealers (EBVS) to be utilised for all or part of laparoscopic mobilisation of the bowel, division of mesentery or transection of mesenteric vessels.
Types of outcome measures
Primary outcomes
Overall blood loss
Complications (intra‐operative and post‐operative), up to 30 days after surgery when available.
Operative time
Secondary outcomes
Conversion to open
Conversion to other laparoscopic instruments
Vessel ligation failure/bleeding episodes
Hospital stay
Surgeon's satisfaction
Cost
Search methods for identification of studies
Electronic searches
See: Cochrane Colorectal Cancer Group methods used in reviews:
Databases including EMBASE, Medline, Cochrane Central Register of Controlled Trials, Cochrane Colorectal Cancer Group Trials Register, Scopus and Google Scholas were searched. The following MeSH terms used were:
Laparoscop*
Minimal* invasive
Colectom*
Electrosurgery
Ultrasonic
Surgical instrument*
Surgical equipment*
Other key words used in the search were: laparoscopic colectomy, electrothermal bipolar vessel sealer, laparoscopic coagulating shears, bipolar energy, ultrasonic shears, colonic vessels ligature, vessels sealing devices and Ligasure. The Boolean operator “AND” or “OR” will be used to combine these headings. No language restriction will be used. Reference lists of published papers will be scrutinised for further citations. For comprehensive search strategy see Appendix 1. These databases were searched on 1/3/10.
Searching other resources
Abstracts presented to the following international scientific societies from 2007 to 2009 were hand‐searched: Association of Coloproctology of Great Britain and Ireland (ACPGBI), American Society of Colon and Rectal Surgeons (ASCRS), European Society of Coloproctology (ESCP) and Society of American Gastrointestinal Endoscopic Surgeons (SAGES). Abstracts were included provided adequate quality data were available.
Data collection and analysis
Selection of studies
Two review authors (ST, AIM) independently examined all the citations and abstracts generated from the electronic searches. Reports of potentially relevant trials were retrieved in full. Any disagreements were resolved by discussing with senior authors (SDW, RLN). Review authors were not blinded to the names of authors, institutions or journals. All uncontrolled, non‐randomised, retrospective studies and duplication of studies were excluded. Excluded studies were documented and the reasons for exclusion stated.
Data extraction and management
Data extraction from the included trial was undertaken independently by two review authors (ST, AIM). Any difference of opinion was resolved by discussion with all the authors. An attempt was made to retrieve missing information from the trial’s authors.
The following data was extracted from each study:
Study method: sample size calculation, randomisation process, and intention‐to‐treat analysis.
Participants: number, age, gender, inclusion and exclusion criteria, type of resection (left, right colectomy, total colectomy, anterior resection), benign, malignant.
Interventions: MES, UCS, EBVS, use of addition instruments for example, vascular staplers and clips for vessel control.
Outcomes: blood loss, complications, operative time, conversion to open approach, conversion to other instruments, vessel ligation failure, bleeding episodes, hospital stay, surgeon’s satisfaction with instruments, cost.
Assessment of risk of bias in included studies
The risk of bias in included studies were assessed according to Cochrane Handbook (Higgins 2008), 5 domains were used in this review:
Adequate sequence generation
Allocation concealment
Incomplete outcome data addressed
Free of selective reporting
Free of other bias
Each domain for each study will be described by ‘yes’, ‘no’ or ‘unclear’ if a risk of bias is thought to be present, absent or uncertain respectively.
Two review authors (ST, AIM) independently assessed the domain as listed above, any disagreement were resolved by consulting the senior authors (SDW, RLN).
Measures of treatment effect
Relative risk or risk ratio (RR) and 95% Confidence Intervals (CI) were calculated for dichotomous outcomes using the Mantel‐Haenszel method and a fixed effect model. Continuous variables were analysed using fixed effect meta‐analyses of mean differences using mean and standard deviation values.
Unit of analysis issues
The primary outcomes were overall blood loss, complications and operative time. Blood loss and operative time were continuous outcome and analysis used was the mean difference and 95% CI. Complications was analysed as dichotomous outcome.
Dealing with missing data
Where data was missing or unclear, authors of included studies were contacted to supply missing data or clarify information. Original data were used when there was no response from the authors or unobtainable. When trials only report means and ranges, an estimate of standard deviation was calculated from the range (range x 0.95/4). When median was used and mean was unobtainable then results could not be used in meta‐analysis. Full paper were requested when only abstract information were available. If missing data was too large/important to ignore, then study may have to be excluded from the review.
Assessment of heterogeneity
For clinical heterogeneity, the trial methods and characteristics in the table of included studies were examined for example, BMI. For statistical heterogeneity, chi‐square test (P<0.1) and I2 statistic were used. If heterogeneity was detected but not substantial, data will be pooled using the random effects method.
Assessment of reporting biases
No funnel plot used as there were less than 10 included studies in our review.
Data synthesis
Data were analysed using the software Review Manager (version 5.0). A fixed effect model was used if there was no heterogeneity present. If heterogeneity was detected but not substantial, data was pooled using the random effects method. Analysis was performed on an intention‐to‐treat basis.
Subgroup analysis and investigation of heterogeneity
Subgroup analysis was not possible as the number of trials for each type of intervention was not more than three.
Sensitivity analysis
Sensitivity analysis was not possible as the number of trials for each type of intervention was not more than three.
Results
Description of studies
See:Characteristics of included studies; Characteristics of excluded studies.
Results of the search
There were 1,669 potentially eligible studies were identified, of which six were included, one awaiting for further data (Adamina 2009), and one excluded (Smart 2009).
Included studies
All trials included are randomised controlled trials published in full paper format. The six studies were from Switzerland (Hubner 2007, Hubner 2008), America (Marcello 2006), Italy (Morino 2005, Rimonda 2009) and Spain (Targarona 2005). They include 446 participants. Both trials Hubner 2007 and Hubner 2008 were from the same institution. Hubner 2007 compared a 5 mm to a 10 mm LigaSureTM (EBVS) for participants who underwent laparoscopic left‐sided colectomy. Hubner 2008 compared 5 mm EndoshearsTM (MES), 5 mm Harmonic ACETM (UCS) and 5 mm LigaSureTM (EBVS) in left‐sided colectomy. Marcello 2006 compared laparoscopic vascular staplers or clips with 10 mm LigaSureTM (EBVS) used for vessel ligation. All right, left and total colectomy were included in the study. Morino 2005 compared monopolar electrocautery device (MES) versus 10 mm UltracisionTM (UCS). Right‐, left‐hemicolectomy and anterior resection were included in the study. Rimonda 2009 compared 10 mm UltracisionTM (UCS) and 10 LigaSureTM (EBVS) in participants underwent right‐, left‐hemicolectomy and anterior resection. Targarona 2005 compared Electrosurgery (MES) vs 5 mm Harmonic scalpel (UCS) vs 10 mm LigaSureTM (EBVS) for participants underwent left‐sided resection. There was one study that was sponsored by Valleybab (Marcello 2006).
Excluded studies
Smart 2009 was excluded as energy source instruments were used on bowel mesentery after bowel was removed from the participants.
Risk of bias in included studies
1.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
2.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Allocation
Three of the six trials (Morino 2005, Rimonda 2009, Targarona 2005) reported adequate generation of the allocation sequence using computer‐generated random numbers before the operations. Allocation concealment, all apart from one trial (Targarona 2005) used sealed envelope prior to surgery.
Blinding
Due to the nature of the studies it is difficult to blind the assessors who are normally the operators. There was no mentioning of blinding of the participants, assessors or care providers in all 6 trials.
Incomplete outcome data
Hubner 2007, Hubner 2008 and Targarona 2005 reported their continuous data with medians and ranges. Through personal communication the means and standard deviations were obtained from Hubner 2007 and Hubner 2008 (see Table 1 and Table 2) but not Targarona 2005. Therefore meta‐analysis were not possible for Targarona' continuous data.
1. Data from Hubner 2007.
| 5 mm LigaSure | 10 mm LigaSure | |||||
| Blood loss (mls) | Operating time (mins) | Hospital stay (days) | Blood loss (mls) | Operating time (mins) | Hospital stay (days) | |
| Mean | 104.7 | 213.1 | 5.7 | 198.1 | 235 | 8.1 |
| SD | 64.7 | 55.7 | 2.6 | 129.5 | 74.9 | 6.2 |
2. Data from Hubner 2008.
| MES | UCS | EBVS | ||||||||||
| Blood loss (mls) | Dissecting time (mins) | Hospital stay (days) | Cost (Euros) | Blood loss (mls) | Dissecting time (mins) | Hospital stay (days) | Cost (Euros) | Blood loss (mls) | Dissecting time (mins) | Hospital stay (days) | Cost (Euros) | |
| Mean | 138.5 | 144.8 | 9.7 | 1476 | 92.5 | 98.5 | 8.1 | 1213 | 108.6 | 104.7 | 9.2 | 1209 |
| SD | 115.1 | 43.4 | 5.8 | 399.1 | 129.3 | 33.6 | 5.1 | 259.1 | 139.1 | 31.8 | 7.0 | 265.8 |
Selective reporting
None identified.
Other potential sources of bias
The lead author in Marcello 2006 was a consultant to Valleylab, Boulder, CO and the study was funded in part by a grant from Valleylab.
Effects of interventions
Comparison 1. MES versus UCS
Across the six studies three of these (Hubner 2008; Morino 2005; Targarona 2005) compared MES and UCS. Continuous data in the Targarona 2005 trial were medians and ranges; therefore meta‐analysis of the outcomes were not possible.
Primary outcomes
When results from Hubner 2008 and Morino 2005 pooled together to examine blood loss there was significantly less blood loss in UCS group compared to the MES group (MD 42 mls, 95% CI 22‐62; Analysis 1.1). Similarly in Targarona 2005, there was significant blood loss in the UCS group (median 100 mls) compared to MES (median 200 mls). With regards to complications there was no significant difference between the two instruments when these three trials were pooled together (Analysis 1.2). Operating time, though shorter in the UCS group compared to MES group; did not reach statistically significant values (Analysis 1.3). The Targarona 2005 reported that operating time in the UCS group was significantly shorter than the MES group (median 120 minutes vs 180 minutes).
1.1. Analysis.
Comparison 1 MES vs UCS, Outcome 1 Blood loss.
1.2. Analysis.
Comparison 1 MES vs UCS, Outcome 2 Complications.
1.3. Analysis.
Comparison 1 MES vs UCS, Outcome 3 Operating time.
Secondary outcomes
There was no conversion to open in Hubner's 2008 study. The pooling of three studies demonstrated no difference between MES and UCS (Analysis 1.4). However there was significant difference in conversion to other laparoscopic instruments during operation in MES group compared to UCS (RR 20, 95% CI 2.7‐146.1; Analysis 1.5). Looking at length of hospital stay a significant shorter stay was found in the UCS group compared to MES, but the mean difference was less than 1 day (MD 0.4 day, 95% CI 0‐0.8; Analysis 1.6). On the other hand the Targarona 2005 trial indicated a median length of stay in the MES group to be at 7 days and UCS was at 8 days. Only Hubner 2008 examined the surgeon's satisfaction in using MES compared to UCS, they have found that the median satisfaction for MES and UCS were the same at 7.7. Major advantages of UCS over MES was bleeding control (median 7.9 vs 5.1; p<0.001), aspect of patient safety (median 7.8 vs 6.0; p<0.001), however surgeons found handling was significantly better in the MES than the UCS (median 8.8 vs 4.8; p<0.001). Base on the annual case load of 100, the cost of UCS was significant less compared to MES (MD 263 Euros, 95% CI 54‐471; Analysis 1.7). There was no difference in cost between MES (median 2995 Euros) and UCS (median 2928 Euros) in Targarona 2005.
1.4. Analysis.
Comparison 1 MES vs UCS, Outcome 4 Conversion to open.
1.5. Analysis.
Comparison 1 MES vs UCS, Outcome 5 Conversion to other laparoscopic instruments.
1.6. Analysis.
Comparison 1 MES vs UCS, Outcome 6 Hospital stay.
1.7. Analysis.
Comparison 1 MES vs UCS, Outcome 7 Cost.
Comparison 2. MES versus EBVS
Two studies (Hubner 2008; Targarona 2005) examined the difference between MES and EBVS. Continous data could not be pooled together as only medians and ranges were available in Targarona's study.
Primary outcomes
There was no significant difference in blood loss in MES and EBVS in Hubner 2008 (Analysis 2.1). Similarly, less blood loss in EBVS (median 100 mls) group compared to MES (median 200 mls) group, though result was not significant (Targarona 2005). No real difference in complications between MES and EBVS (Analysis 2.2). The operating time was significantly faster in EBVS group compared to MES (MD 40 minutes, 95% CI 17‐63; Analysis 2.3). This is similar in Targarona's study where the median operating time for EBVS was 110 minutes and 180 minutes in MES group (p<0.01).
2.1. Analysis.
Comparison 2 MES vs EBVS, Outcome 1 Blood loss.
2.2. Analysis.
Comparison 2 MES vs EBVS, Outcome 2 Complications.
2.3. Analysis.
Comparison 2 MES vs EBVS, Outcome 3 Operating time.
Secondary outcomes
No difference was found in the case of conversion to open between two groups (Analysis 2.4). Three of the MES group and one of the EBVS group converted to other laparoscopic instruments but there was no significant difference (Analysis 2.5). No difference in hospital stay was found between MES and EBVS in Hubner 2008 (Analysis 2.6) and Targarona 2005 (MES, median stay 7 days, EBVS median stay 6 days). In terms of surgeon's satisfaction (Hubner 2008) the median satisfaction for MES and EBVS were the 7.7 and 8.0 respectively. Major advantages of EBVS over MES was bleeding control (median 8.4 vs 5.1; p<0.001), safety aspects (median 8.6 vs 6.0; p<0.001), whilst handling was similar in MES and EBVS (median 8.8 vs 7.9). Base on case load of 100/annum, the cost of laparoscopic colectomy using EBVS was significantly cheaper compared to MES (MD 267 Euros, 95% CI 58‐476; Analysis 2.7). No difference in cost between MES (median 2995 Euros) and EBVS (Median 2664 Euros) was observed (Targarona 2005).
2.4. Analysis.
Comparison 2 MES vs EBVS, Outcome 4 Conversion to open.
2.5. Analysis.
Comparison 2 MES vs EBVS, Outcome 5 Conversion to other laparoscopic instruments.
2.6. Analysis.
Comparison 2 MES vs EBVS, Outcome 6 Hospital stay.
2.7. Analysis.
Comparison 2 MES vs EBVS, Outcome 7 Cost.
Comparison 3. UCS versus EBVS
Three studies examined the difference between UCS and EBVS (Hubner 2008; Rimonda 2009; Targarona 2005). As mentioned above, continuous data in Targarona 2005 were given as medians and ranges therefore not suitable for meta‐analysis.
Primary outcomes
There was no difference in blood loss and complications between UCS and EBVS (Analysis 3.1; Analysis 3.2). Median blood loss in both UCS and EBVS was 100 mls in Targarona 2005. No difference in operative time between two instruments (Analysis 3.3). No difference in median operating time in Targarona 2005 (UCS 120 minutes, EBVS 110 minutes).
3.1. Analysis.
Comparison 3 UCS vs EBVS, Outcome 1 Blood loss.
3.2. Analysis.
Comparison 3 UCS vs EBVS, Outcome 2 Complications.
3.3. Analysis.
Comparison 3 UCS vs EBVS, Outcome 3 Operating time.
Secondary outcomes
No difference had been found and open conversion, conversion to other laparoscopic instruments, hospital stay and cost between UCS and EBVS were relatively similar in characteristics (Analysis 3.4; Analysis 3.5; Analysis 3.6; Analysis 3.7). Median hospital stay (UCS 8 days, EBVS 6 days) of both instruments were also not significant (Targarona 2005). Overall median satisfaction, bleeding control, safety aspects were comparable between UCS and EBVS. However handling was a less satisfactory in UCS (4.8; 7.9 in EBVS).
3.4. Analysis.
Comparison 3 UCS vs EBVS, Outcome 4 Conversion to open.
3.5. Analysis.
Comparison 3 UCS vs EBVS, Outcome 5 Conversion to other laparoscopic instruments.
3.6. Analysis.
Comparison 3 UCS vs EBVS, Outcome 6 Hospital stay.
3.7. Analysis.
Comparison 3 UCS vs EBVS, Outcome 7 Cost.
Comparison 4. 5 mm EBVS versus 10 mm EBVS
Only one study examined the difference between 5 mm EBVS and 10 mm EBVS (Hubner 2007).
Primary outcomes
There was significant less blood loss when using 5 mm EBVS compared to 10 mm EBVS (MD 93 mls, 95% CI 20‐167; Analysis 4.1), however complications were comparable between the two groups (Analysis 4.2). No difference in operating time between the two instruments (Analysis 4.3).
4.1. Analysis.
Comparison 4 5 mm LigaSure vs 10 mm Ligasure, Outcome 1 Blood loss.
4.2. Analysis.
Comparison 4 5 mm LigaSure vs 10 mm Ligasure, Outcome 2 Complications.
4.3. Analysis.
Comparison 4 5 mm LigaSure vs 10 mm Ligasure, Outcome 3 Operating time.
Secondary outcomes
Open conversion, hospital stay were similar between the two groups (Analysis 4.4; Analysis 4.5).
4.4. Analysis.
Comparison 4 5 mm LigaSure vs 10 mm Ligasure, Outcome 4 Conversion to open.
4.5. Analysis.
Comparison 4 5 mm LigaSure vs 10 mm Ligasure, Outcome 5 Hospital stay.
With regards to surgeon's evaluation of the instruments, the 5 mm EBVS was significantly favoured by the surgeons over the 10 mm EBVS in terms of dissection (median score of 8.7 vs 6.2), visibility conditions (8.4 vs 7.3), handgrip (7.9 vs 6.3), handling (8.5 vs 5.7), limited space for dissection (8.2 vs 6.1) and overall satisfaction (8.4 vs 6.9). There was no statistically significant difference between the two instruments for the following specifics: sealing and cutting capacity, speed of dissection, management of bleeding, seal and cut width, security and reliability. The main advantage of the 5 mm EBVS was its trocar flexibility and it is a drawback for the 10 mm instrument.
Comparison 5. Laparoscopic staplers/clips versus EBVS
One study examined the vascular pedicle ligation techniques during laparoscopic colectomy (Marcello 2006) using either laparoscopic staplers/clips versus 10 mm EBVS.
Primary outcomes
There was no difference in bleeding and complications between the two techniques in pedicle ligation (Analysis 5.1; Analysis 5.2). Operating time was similar between the two techniques (Analysis 5.3).
5.1. Analysis.
Comparison 5 Laparoscopic staplers/clips vs LigaSure, Outcome 1 Bleeding.
5.2. Analysis.
Comparison 5 Laparoscopic staplers/clips vs LigaSure, Outcome 2 Complications.
5.3. Analysis.
Comparison 5 Laparoscopic staplers/clips vs LigaSure, Outcome 3 Operating time.
Secondary outcomes
There was no conversion in either groups (Analysis 5.4). There were 14 cases of vessel ligation failure in staplers/clips group compared to 5 in EBVS group and the result was significant (RR 3.1, 95% CI 1.2‐8.4; Analysis 5.5). There was a significant cost reduction in the EBVS group compared to laparoscopic staplers/clips in pedicle ligation (MD 83 US dollars, CI 51‐115; Analysis 5.6).
5.4. Analysis.
Comparison 5 Laparoscopic staplers/clips vs LigaSure, Outcome 4 Conversion to open.
5.5. Analysis.
Comparison 5 Laparoscopic staplers/clips vs LigaSure, Outcome 5 Vessel ligation failure.
5.6. Analysis.
Comparison 5 Laparoscopic staplers/clips vs LigaSure, Outcome 6 Cost.
Discussion
Laparoscopic colectomy is increasing being utilised for both benign and malignant bowel conditions. Advancements in surgical technology and improved choice of surgical instruments have enabled more complex operations to be performed. So what is the evidence so far?
Summary of main results
Comparison 1. MES versus UCS
All three studies have shown significantly less blood loss in the UCS when compared to MES. This would translate to better haemostatic control of UCS during operations as compared to MES which had less control. There was no difference in terms of complications reported between these two instruments. Operating time was not significantly different when results from the two studies were pooled, but the findings showed that there was heterogeneity (I2=87%). The other study (Targarona 2005) showed that operating time was significantly shorter in the UCS group compared to MES. No difference in conversion to open between two groups was found but more cases in the MES group were converted to other laparoscopic instruments (to UCS in Morino’s study) due to various reasons including difficulties with exposure or continuous dissection, presence of fibrotic tissue or abdominal adhesions. Hospital stay was significant between the two groups although the difference was less than 1 day. Two studies examined the cost of using these two instruments. There was significant savings in performing laparoscopic colectomy with UCS; this is based on the annual caseload of 100. No difference in cost was indicated in Targarona’s study. In terms of procedural costs, this is dependent mainly on the cost materials and the operating time.
Comparison 2. MES versus EBVS
There was no difference in blood loss, complications, open conversion, conversion to other laparoscopic instruments and hospital stay between these two instruments. Operating time was significantly shorter in EBVS compared to MES. In terms of surgeon’s satisfaction, the major advantages of EBVS over MES include bleeding control and its safety aspect. Similar to the above comparison (Comparison 1), there was a significant cost saving in the EBVS group compared to the MES group but no difference in these 2 groups in Targarona’s study.
Comparison 3. UCS versus EBVS
There was no difference in outcomes between these two instruments although it was found that there was a preference over one instrument to another; handling of instruments was less satisfactory in UCS compared to EBVS.
Comparison 4. 5 mm EBVS versus 10 mm EBVS
There was significantly less blood loss in the 5 mm instrument compared to the 10 mm instrument. No difference was found relating to complications, operating time, open conversion and hospital stay. The 5 mm EBVS was preferred by surgeons particularly around dissection, visibility conditions, handgrip, handling, limited space for dissection and its trocar flexibility.
Comparison 5. Laparoscopic staplers/clips versus EBVS
No difference in bleeding, complications, operating time, open conversion between two different techniques was found. There was significantly more failure in vessel ligation in staplers/clips group compared to using EBVS. The cost of using EBVS was cheaper between the two techniques.
Overall completeness and applicability of evidence
The main draw back of this review is the low number of publications available in the literature and the heterogenous nature of these studies. However the evidence from this review can act as a guide to help surgeons choose the appropriate instruments to suit their needs.
Quality of the evidence
Due to the nature of the studies it was difficult to the blind assessors; who would in most instances be the surgeons performing the operations. Overall the studies quality were good, appeared to be well designed, methodical in approach and delivery. The quality of individual studies are discussed below:
There was no mention of sequence generation in the study and it would appear that a sample size calculation was not undertaken. There was a small sample size with 15 participants in each group. Inclusion criteria was left‐sided colectomy. The study provided no mention of undertaking an intention‐to‐treat analysis. The baselines between the two groups were comparable. No financial support for this study.
There was no mention of sequence generation in the study. Sample size calculation was performed and a total of 61 participants were recruited. Inclusion criteria was left sided colectomy and the study had defined exclusion criteria. No intention‐to‐treat analysis mentioned. The baselines between two groups were comparable. No financial support for the study.
There was no mention of sequence generation in the study. Sample size calculation was performed with total of 100 participants. Inclusion criteria was right, left and total colectomy and participants converted to open procedure before pedicle ligation or colon mobilisation were excluded from the study. There was BMI difference in the baselines. The lead author is a consultant to Valleylab and the study was funded in part by a grant from Valleylab.
There was adequate generation of sequence performed produced through a series of computer generated range of random numbers. Sample size calculation was performed with a total of 146 participants recruited to the trial. Inclusion criteria was right, left colectomy and anterior resection. Pathology of transverse colon, previous large bowel surgery and abdomino‐perineal excision of rectum was excluded. Intention‐to‐treat analysis was applied. Baselines was similar in both groups. There was no financial support for the study.
There was adequate generation of sequence and was performed with computer generated random numbers. Sample size calculation was performed with a total of 140 participants. Inclusion criteria was right, left colectomy and anterior resection. Pathology of transverse colon, previous large bowel surgery and abdomino‐perineal excision of rectum was excluded. Intention‐to‐treat analysis was applied. Baselines was similar in both groups. There was no financial support for the study.
Adequate generation of sequence was available by an electronic randomisation system. Sample size calculation was performed but a potential weakness is the small sample of 38 participants. Inclusion criteria was lesion located 15 cm above the anal margin and below the splenic flexure of the colon. Exclusion criteria was advanced local disease (T4) or previous resective bowel surgery. Intention‐to‐treat analysis was applied. Baselines was similar in both groups. There was no financial support for the study.
Potential biases in the review process
The lead author in Marcello 2006 study was a consultant to Valleylab, Boulder, CO and study was funded in part from the same company.
Agreements and disagreements with other studies or reviews
N/A
Authors' conclusions
Implications for practice.
The findings showed less blood loss in UCS compared to MES. Operating time using EBVS was quicker than MES. No difference between UCS and EBVS was found. Haemostatic control was better in UCS/EBVS than MES. The cost between the use of MES, UCS, EBVS depends on the balance of instrument costs and operating time. Handling of 5 mm EBVS was better than 10 mm instrument and the advantage for 5 mm instrument was its flexibility with trocar. Laparoscopic staplers/clips used for pedicle ligation in colectomy was associated with more vessel ligation failure and costs were higher when compared to EBVS, though this finding was based on one single study.
Implications for research.
As trials included were small and heterogeneous, a well planned large RCT is needed to clarify the clinical questions. Ideally that will involve surgeons who have passed the learning curve in performing laparoscopic colectomy, comfortable with all the different types of energy source instruments and have a standard method of ligating the pedicles.
Notes
Poster presentation at European Society of Coloproctology Annual Meeting in Prague. 23‐26 September 2009. Abstract in Colorectal Diease 2009; 11 (suppl 2):40.
Acknowledgements
We would like to thank Dr H K Andersen, Stine Kjær Hovgaard, Isla Kuhn and Wendy Tou for their support in this review.
Appendices
Appendix 1. Search Strategy
The Cochrane Library (1/3/10)
#1 (surgical dissection*):ti,ab,kw 392
#2 (surgery):ti,ab,kw 68643
#3 (mes or ucs or ebvs):ti,ab,kw 100
#4 (surgical instrument*):ti,ab,kw 1817
#5 (surgical instrument*) 3300
#6 (mes or ucs or ebvs) 131
#7 (surgical dissection*) 816
#8 (surgery) 84611
#9 (surgical equipment*) 1295
#10 (laparoscop*) 37
#11 (minimal* invasive) 1675
#12 (electrosurg*) 263
#13 (ultrason*):ti,ab,kw 9424
#14 (ultrason*) 9803
#15 (#14 OR #13 OR #11 OR #10 OR #9 OR #8 OR #7 OR #6 OR #5) 93331
#16 MeSH descriptor Electrosurgery explode all trees 160
#17 MeSH descriptor Laparoscopy explode all trees 3454
#18 MeSH descriptor Colectomy explode all trees 499
#19 (colectom*) 554
#20 (electrothermal bipolar vessel seale*) or (laparoscopic coagulating shear*) or (bipolar energ*) or (ultrasonic*) or (shear*) or (vessels sealing) or (device) or (harmonic scalpel) or (ligasure) 15125
#21 MeSH descriptor Surgical Equipment explode all trees 7820
#22 (#15 OR #16 OR #17 OR #20 OR #21) 106506
#23 (#18 OR #19) 652
#24 (#22 AND #23) 567
EMBASE (1/3/10)
1. EMBASE; exp COLECTOMY/; 12216 results.
2. EMBASE; colectomy.ti,ab; 4794 results.
3. EMBASE; ("surgical dissection*" OR surgery OR MES OR UCS OR EBVS OR "surgical instrument*" OR "surgical equipment*" OR laparoscop* OR "minimal* invasive" OR electrosurg* OR ultrason*).af; 1440085 results.
4. EMBASE; ("electrothermal bipolar vessel seale*" OR "laparoscopic coagulating shear*" OR "bipolar energ*" OR ultrasonic* OR shear* OR "vessels sealing" OR device* OR "harmonic scalpel" OR ligasure*).af; 210189 results.
5. EMBASE; exp SURGICAL EQUIPMENT/; 130011 results.
6. EMBASE; exp SURGICAL INSTRUMENTS/; 6312 results.
7. EMBASE; exp ELECTROSURGERY/; 5583 results.
8. EMBASE; exp SURGICAL PROCEDURES, MINIMALLY INVASIVE/; 11449 results.
9. EMBASE; 1 OR 2; 13439 results.
10. EMBASE; 6 OR 7 OR 8; 22712 results.
11. EMBASE; ("surgical dissection*" OR surgery OR MES OR UCS OR EBVS OR "surgical instrument*" OR "surgical equipment*" OR laparoscop* OR "minimal* invasive" OR electrosurg* OR ultrason*).ti,ab; 542227 results.
12. EMBASE; ("electrothermal bipolar vessel seale*" OR "laparoscopic coagulating shear*" OR "bipolar energ*" OR ultrasonic* OR shear* OR "vessels sealing" OR device* OR "harmonic scalpel" OR ligasure*).ti,ab; 156736 results.
13. EMBASE; 5 OR 11 OR 12; 758494 results.
14. EMBASE; 10 OR 13; 763658 results.
15. EMBASE; "randomised controlled trial" OR "controlled clinical trial".pt; 187575 results.
16. EMBASE; randomised OR placebo.ab; 112483 results.
17. EMBASE; CLINICAL TRIAL/; 580409 results.
18. EMBASE; randomly.ab; 124205 results.
19. EMBASE; trial.ti; 74522 results.
20. EMBASE; 15 OR 16 OR 17 OR 18 OR 19; 728068 results.
21. EMBASE; HUMANS/; 6852724 results.
22. EMBASE; 20 AND 21; 675246 results.
23. EMBASE; 9 AND 14 AND 22; 548 results.
24. EMBASE; (random* OR factorial* OR crossover* OR "cross over*" OR placebo* OR "double blind*" OR "singl* blind" OR assign* OR allocat* OR volunteer*).ti,ab; 672751 results.
25. EMBASE; CROSSOVER PROCEDURE/; 22488 results.
26. EMBASE; RANDOMIZED CONTROLLED TRIAL/; 181916 results.
27. EMBASE; SINGLE BLIND PROCEDURE/; 9078 results.
28. EMBASE; DOUBLE BLIND PROCEDURE/; 76330 results.
29. EMBASE; 24 OR 25 OR 26 OR 27 OR 28; 708812 results.
30. EMBASE; exp COLON RESECTION/; 12216 results.
31. EMBASE; (colectom* OR "colon resection*").ti,ab; 5530 results.
32. EMBASE; 30 OR 31; 13705 results.
33. EMBASE; exp SURGICAL INSTRUMENT/; 6312 results.
34. EMBASE; exp SURGICAL EQUIPMENT/; 130011 results.
35. EMBASE; exp ELECTROSURGERY/; 5583 results.
36. EMBASE; exp SURGICAL TECHNIQUE/; 545066 results.
37. EMBASE; exp MINIMALLY INVASIVE SURGERY/; 11449 results.
38. EMBASE; 11 OR 12 OR 33 OR 34 OR 35 OR 36 OR 37; 1095255 results.
39. EMBASE; 29 AND 32 AND 38; 619 results.
Medline (1/3/10)
1. MEDLINE; exp COLECTOMY/; 11805 results.
2. MEDLINE; colectomy.ti,ab; 5838 results.
3. MEDLINE; ("surgical dissection*" OR surgery OR MES OR UCS OR EBVS OR "surgical instrument*" OR "surgical equipment*" OR laparoscop* OR "minimal* invasive" OR electrosurg* OR ultrason*).af; 1518298 results.
4. MEDLINE; ("electrothermal bipolar vessel seale*" OR "laparoscopic coagulating shear*" OR "bipolar energ*" OR ultrasonic* OR shear* OR "vessels sealing" OR device* OR "harmonic scalpel" OR ligasure*).af; 271738 results.
5. MEDLINE; exp SURGICAL EQUIPMENT/; 187215 results.
6. MEDLINE; exp SURGICAL INSTRUMENTS/; 17249 results.
7. MEDLINE; exp ELECTROSURGERY/; 3283 results.
8. MEDLINE; exp SURGICAL PROCEDURES, MINIMALLY INVASIVE/; 213247 results.
9. MEDLINE; 1 OR 2; 14459 results.
10. MEDLINE; 6 OR 7 OR 8; 230462 results.
11. MEDLINE; ("surgical dissection*" OR surgery OR MES OR UCS OR EBVS OR "surgical instrument*" OR "surgical equipment*" OR laparoscop* OR "minimal* invasive" OR electrosurg* OR ultrason*).ti,ab; 675667 results.
12. MEDLINE; ("electrothermal bipolar vessel seale*" OR "laparoscopic coagulating shear*" OR "bipolar energ*" OR ultrasonic* OR shear* OR "vessels sealing" OR device* OR "harmonic scalpel" OR ligasure*).ti,ab; 210938 results.
13. MEDLINE; 5 OR 11 OR 12; 980503 results.
14. MEDLINE; 10 OR 13; 1124697 results.
15. MEDLINE; "randomised controlled trial" OR "controlled clinical trial".pt; 361132 results.
16. MEDLINE; randomised OR placebo.ab; 118224 results.
17. MEDLINE; CLINICAL TRIAL/; 453377 results.
18. MEDLINE; randomly.ab; 146226 results.
19. MEDLINE; trial.ti; 85182 results.
20. MEDLINE; 15 OR 16 OR 17 OR 18 OR 19; 674905 results.
21. MEDLINE; HUMANS/; 11011258 results.
22. MEDLINE; 20 AND 21; 610136 results.
23. MEDLINE; 9 AND 14 AND 22; 483 results.
Data and analyses
Comparison 1. MES vs UCS.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Blood loss | 2 | 186 | Mean Difference (IV, Fixed, 95% CI) | 42.09 [22.16, 62.02] |
| 2 Complications | 3 | 209 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.28 [0.72, 2.27] |
| 3 Operating time | 2 | 186 | Mean Difference (IV, Random, 95% CI) | 26.20 [‐9.60, 62.00] |
| 4 Conversion to open | 3 | 209 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.03 [0.44, 2.41] |
| 5 Conversion to other laparoscopic instruments | 2 | 169 | Risk Ratio (M‐H, Fixed, 95% CI) | 19.88 [2.71, 146.10] |
| 6 Hospital stay | 2 | 186 | Mean Difference (IV, Fixed, 95% CI) | 0.42 [‐0.00, 0.84] |
| 7 Cost | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | 263.0 [54.46, 471.54] |
Comparison 2. MES vs EBVS.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Blood loss | 1 | 41 | Mean Difference (IV, Fixed, 95% CI) | 29.90 [‐48.10, 107.90] |
| 2 Complications | 2 | 67 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.30 [0.73, 2.32] |
| 3 Operating time | 1 | 41 | Mean Difference (IV, Fixed, 95% CI) | 40.10 [16.72, 63.48] |
| 4 Conversion to open | 2 | 67 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.36 [0.10, 19.50] |
| 5 Conversion to other laparoscopic instruments | 1 | 26 | Risk Ratio (M‐H, Fixed, 95% CI) | 4.09 [0.49, 34.26] |
| 6 Hospital stay | 1 | 41 | Mean Difference (IV, Fixed, 95% CI) | 0.5 [‐3.33, 4.33] |
| 7 Cost | 1 | 41 | Mean Difference (IV, Fixed, 95% CI) | 267.0 [58.39, 475.61] |
Comparison 3. UCS vs EBVS.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Blood loss | 2 | 181 | Mean Difference (IV, Fixed, 95% CI) | ‐3.74 [‐19.04, 11.55] |
| 2 Complications | 3 | 208 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.81 [0.46, 1.40] |
| 3 Operating time | 2 | 181 | Mean Difference (IV, Fixed, 95% CI) | ‐3.22 [‐15.31, 8.87] |
| 4 Conversion to open | 3 | 208 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.03 [0.36, 2.96] |
| 5 Conversion to other laparoscopic instruments | 1 | 27 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.41 [0.02, 9.25] |
| 6 Hospital stay | 2 | 181 | Mean Difference (IV, Fixed, 95% CI) | 0.41 [‐0.49, 1.31] |
| 7 Cost | 1 | 41 | Mean Difference (IV, Fixed, 95% CI) | 4.0 [‐156.68, 164.68] |
Comparison 4. 5 mm LigaSure vs 10 mm Ligasure.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Blood loss | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐93.40 [‐166.66, ‐20.14] |
| 2 Complications | 1 | 30 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.0 [0.31, 3.28] |
| 3 Operating time | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐21.90 [‐69.14, 25.34] |
| 4 Conversion to open | 1 | 30 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.01, 7.58] |
| 5 Hospital stay | 1 | 30 | Mean Difference (IV, Fixed, 95% CI) | ‐2.40 [‐5.80, 1.00] |
Comparison 5. Laparoscopic staplers/clips vs LigaSure.
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|---|---|---|---|
| 1 Bleeding | 1 | 100 | Mean Difference (IV, Fixed, 95% CI) | 14.0 [‐51.31, 79.31] |
| 2 Complications | 1 | 100 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.36 [0.02, 8.64] |
| 3 Operating time | 1 | 100 | Mean Difference (IV, Fixed, 95% CI) | 11.0 [‐15.00, 37.00] |
| 4 Conversion to open | 1 | 100 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.0 [0.0, 0.0] |
| 5 Vessel ligation failure | 1 | 321 | Risk Ratio (M‐H, Fixed, 95% CI) | 3.11 [1.15, 8.44] |
| 6 Cost | 1 | 100 | Mean Difference (IV, Fixed, 95% CI) | 83.0 [51.32, 114.68] |
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Hubner 2007.
| Methods | Single centre RCT (Switzerland) | |
| Participants | Participants: 30 (details of age and gender not mentioned) | |
| Interventions | LigaSure (5 mm vs 10 mm) | |
| Outcomes | Blood loss, complications, operative time, conversions, hospital stay, (surgeon's satisfaction and handling) | |
| Notes | Inclusion criteria: left sided colectomy Exclusion criteria: not mentioned Operative time: from skin incision to skin closure (from communication with author) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Low risk | Closed envelope |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | Authors did not receive financial support from the manufacturers |
Hubner 2008.
| Methods | Single centre RCT (Switzerland) | |
| Participants | Participants: 61 (25 males, 36 females), median age 62 years, range 33‐84 | |
| Interventions | Endo Shears (5 mm) vs LigaSure (5 mm) vs Harmonic ACE (5 mm) | |
| Outcomes | Blood loss, complications, operative time, conversions (no conversion according to the author), hospital stay, (cost, surgeon's satisfaction and handling) | |
| Notes | Inclusion criteria: left sided colectomy for participants above 18 years of age Exclusion criteria: right sided or total colectomy Dissection: from dissection of inferior mesenteric vessels to complete mobilisation of left colon |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Low risk | Sealed envelope (the day before surgery to allow nursing staff to prepare allocated instruments) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | Authors did not receive financial support from the manufacturers |
Marcello 2006.
| Methods | Single centre RCT (USA) | |
| Participants | Participants: 100 (54 males, 46 females), mean age 53 (21‐84) | |
| Interventions | Laparoscopic vascular staplers (ETS‐Flex45 Endoscopic Linear Cutter)/clips (ER420 large Ligaclip) vs LigaSure Atlas (10 mm) | |
| Outcomes | Blood loss, (complications ‐ not really mentioned in the paper), operative time, conversion, device failure, cost | |
| Notes | Inclusion criteria: right, left and total colectomy Exclusion criteria: participants were converted to open before pedicle ligation or colon mobilisation Failure of vascular pedicle ligation was defined as any bleeding after proper pedicle ligation technique One participant was excluded as at the time of laparoscopy as caecal cancer invading retroperitoneum and procedure was converted to open (before ligation of pedicle) Operative time: from skin incision to wound closure BMI in 2 groups were significantly different Staplers were used for ileocolic and inferior mesenteric pedicles and clips were used for smaller vessels |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Low risk | Sealed envelope |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | High risk | Funded in part by a grant from Valleylab, author is a consultant to Valleylab, mainly about the cost BMI in 2 groups were significantly different |
Morino 2005.
| Methods | Single centre RCT (Italy) | |
| Participants | Participants: 146 (89 males, 57 females), mean age: not given | |
| Interventions | Monopolar electrocautery device vs Ultracision (10 mm), pedicles were controlled with clips | |
| Outcomes | Blood loss, complications, operative time, conversions, hospital stay, (abdominal drainage output at 48 hours post‐operation, haematological investigation at day 4 post‐operation, first passage of flatus/stool) | |
| Notes | Inclusion criteria: participants eligible for laparoscopic right, left hemicolectomy, anterior resection Exclusion criteria: pathology of transverse colon, previous large bowel surgery, APER A longer incision or an incision earlier than planned was considered conversion to laparotomy Monopolar electrocautery to Ultracision conversion if surgeons change instruments for haemostatic control Intention to treat: yes Operative time = creation of pneumoperitoneum to mini‐laparotomy |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated random numbers |
| Allocation concealment (selection bias) | Low risk | Sealed envelope |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |
Rimonda 2009.
| Methods | Single centre RCT (Italy) | |
| Participants | Participants: 140 (93 males, 47 females), median age 65.9 (range not given) | |
| Interventions | Ultracision (10 mm) vs LigaSure (10 mm), pedicles were controlled with clips | |
| Outcomes | Blood loss, complications, operative time, conversions, hospital stay, (carbon dioxide insufflation, blood transfusion, abdominal drainage output at 48 hours post‐operation, haematological investigation at day 4 post‐operation, first passage of flatus/stool) | |
| Notes | Inclusion criteria: participants eligible for laparoscopic right, left hemicolectomy, anterior resection Exclusion criteria: pathology of transverse colon, previous large bowel surgery, APER A longer incision or an incision earlier than planned was considered conversion to laparotomy Intention to treat ‐ yes Operative time = creation of pneumoperitoneum to mini‐laparotomy |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | |
Targarona 2005.
| Methods | Single centre RCT (Spain) | |
| Participants | Participants: 38 (28 males, 9 females), median age (years) was given in each group, MES 71, UCS 63, EBVS 70 | |
| Interventions | Electrosurgery vs Harmonic Scalpel (5 mm) vs LigaSure (10 mm), pedicles controlled by clips (Electrosurgery), endostapler (Harmonic Scalpel) and LigaSure (LigaSure) | |
| Outcomes | Blood loss, complications, operative time, conversions, hospital stay, (re‐operation), cost | |
| Notes | Inclusion criteria: participant with lesion located 15 cm above the anal margin and below the splenic flexure of the colon Exclusion criteria: advanced local disease (T4), or previous resective bowel surgery Conversion was defined as any change from scheduled energy device, or to hand‐assisted or open surgery Open conversion was defined as the conversion to open surgery, or any unplanned extension of the accessory incision Intention to treat ‐ yes Operating time: no mention whether was operating time or dissecting time |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated random numbers |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Unclear risk | In power calculation, power of 80% for a reduction of 30% of operative time, very small sample size for each group |
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
|---|---|
| Smart 2009 | This study used different energy source instruments on the mesenteric vessels once the colon has been removed from the participants rather than for actual dissection during the operation |
Characteristics of studies awaiting assessment [ordered by study ID]
Adamina 2009.
| Methods | Single centre RCT (USA) |
| Participants | Participants: 59 |
| Interventions | Laparosopic stapler/clips vs LigaSure |
| Outcomes | Blood loss, operating time, conversion, hospital stay, cost |
| Notes | Abstract published in 2009, awaiting full paper version |
Differences between protocol and review
N/A
Contributions of authors
Draft the protocol (ST, AIM, SDW, RLN)
Develop the search strategy (ST, AIM, SDW, RLN)
Extract data (ST, AIM)
Data analysis (ST, AIM)
Construction of review (ST, AIM, SDW, RLN)
Declarations of interest
Steven D Wexner is a consultant for SurgRx, Inc. and Ethicon Inc., and receive royalties for intellectual property from Covidien Ltd.
New
References
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