Single incision laparoscopic cholecystectomy: for what benefit?

Abstract

Background A single-incision laparoscopic cholecystectomy (SILC) was developed to improve outcomes as compared with the four-port classic laparoscopic cholecystectomy (CLC). Any potential benefits associated with a SILC have been suggested by previous studies reporting few patients with different surgical techniques. The aim of this study was to describe the experience with a standardized SILC as compared with CLC.

Methods From June 2010 to January 2012, 40 patients underwent a SILC [median age: 47.5 years (25–92)] and operative and peri-operative data were prospectively collected. Over the same period, 37 patients underwent a CLC. A 10-point visual analogue scale (VAS) was used for qualitative data. The costs of SILC and CLC were also compared.

Results For those patients undergoing a SILC the median operating time was 70 min (24–110). There were no conversions. An additional trocar was necessary in 16 patients. Four patients developed post-operative complications. The median immediate post-operative pain score was 5 (0–10). The median quality of life and cosmetic satisfaction at the initial post-operative visit were 10 (6–10) and 10 (5–10), respectively (VAS). Although the surgical results of both groups were similar, post-operative complications were exclusively reported in the SILC group (two incisional hernias).

Conclusion Standardization of SILC is possible but associated with an important rate of additional trocar placement and a disturbing rate of incisional hernias.

Introduction

Laparoscopic cholecystectomy is one of the most common procedures in general surgery with few complications and relatively little loss of normal activity.¹ A single incision laparoscopic cholecystectomy (SILC) was developed in the late 1990s as a natural evolution of the reduced port concept in order to improve the outcomes of a four-port laparoscopic cholecystectomy.^2,3 The underlying principle for using fewer incisions is to minimize tissue trauma and improve post-operative pain and cosmesis for patients. These benefits of SILC have been suggested by several surgical teams^2–21 and a recent meta-analysis advocated that SILC is a safe procedure for the treatment of uncomplicated gallstone disease, with a post-operative outcome similar to that of a standard multiport laparoscopic cholecystectomy.¹⁰ However, most of these previous studies reported small numbers of patients and different surgical techniques. Indeed, some authors reported the use of a multiport device whereas others used three separate trocars in one incision.^2,9,11–21

Locally, SILC was commenced in February 2009. In spite of previous advanced experience in laparoscopic liver surgery,^22–24 several difficulties were encountered in the authors’ first attempts of SILC. The main reason for this was that instrument triangulation, which allows a good dissection of the cystic pedicle during conventional laparoscopic cholecystectomy, was not possible during SILC. Thus, a considerable initial experience was necessary in order to standardize the technique of SILC.

The aim of this retrospective study was to report an experience of a standardized SILC and examine the short- and long-term benefits associated with this procedure as compared with the four-port classic laparoscopic cholecystectomy (CLC). Furthermore, the cost of SILC was compared with CLC to assess whether this procedure was sustainable.

Methods

In a preliminary period, 20 SILC procedures were performed using different surgical devices (0° or 30° rigid laparoscope, approved or not multiport trocars and curved or not laparoscopic instruments) and those patients who formed the initial learning curve and permitted to standardize the technique, were excluded. After June 2010, all consecutive patients were operated with the standardized technique and were included in this study. The inclusion criteria for SILC were: gallstones, gallbladder polyps, a previous episode of biliary pancreatitis and a previous episode of gallstone migration. Exclusion criteria were: cholecystitis, a suspicion or proved persistence of a choledocholithiasis, necrotic pancreatitis, a body mass index (BMI) higher than 40 and a history of liver disease or upper abdominal surgery. Patients undergoing CLC during the same time period for the same indications were included for comparison.

Surgical technique

The standardized technique of SILC was as follows. All surgeons had extensive experience with a classic four trocar laparoscopic cholecystectomy. A 2-cm incision on the umbilicus was performed and an approved disposable four instrument channels trocar (Quadriport, Olympus, Rungis, France) was employed (Fig. 1). A flexible laparoscope system (endoEYE, Olympus) was used with a non-disposable double-curved grasper to avoid having to cross instruments. In the situations where Calot's triangle could not be adequately exposed, the fundus of the gallbladder was grasped and attached to the upper abdominal wall with a stitch. The infundibulum was grasped with a forceps and retracted laterally and slightly upward to expose Calot's triangle. The cystic duct and the cystic artery were carefully dissected and subsequently ligated, using 8-mm absorbable clips (Laproclip, Covidien, France) and sectioned. The gallbladder was then grasped and retracted so that it could be dissected from the liver bed in a retrograde manner. Once freed, the gallbladder was extracted through the umbilicus protected by the single incision trocar. Conversion to a conventional laparoscopic cholecystectomy was performed when needed by the addition of one or two non-disposable trocars. After removing the single incision trocar, the umbilical fascia was closed with a 0 polyglactin running suture. This closure was sometimes difficult as the aponeurotic incision was larger than the cutaneous incision.

Figure 1.

Control of the cystic duct by single incision laparoscopy

Classic procedures were performed with two 5-mm ports and two 10-mm ports and non-disposable instruments as previously reported.^1,25

Statistical analysis

Data concerning all patients who underwent SILC were prospectively collected. Operative and peri-operative outcomes were analysed. The surgical variables evaluated were the duration of the intervention, conversion rate, number of additional trocars, peri-operative morbidity (including a haemorrhage defined as any bleeding from the cystic artery or the liver bed requiring the use of an irrigation suction device and bipolar coagulation). The post-operative variables assessed were peri- and post-operative morbidity, length of hospital stay, post-operative pain scores at hospital discharge and at the initial post-operative follow visit using a standard 10-point visual analog scale (VAS). The quality of life (QOL) and the patient cosmetic satisfaction was measured at the initial post-operative visit using a standard 10-point scale.

The cost of SILC and CLC were collected. For every cholecystectomy, the costs of materials and the costs related to duration of surgery (cost per hour) and hospital stay (ambulatory surgery cost and cost per hospitalization day) were recorded. The costs of the materials were the sum of the consumables (clips, suture, single incision trocar and additional disposble trocar). Fixed costs that are independent of the type of procedure, such as maintenance, fluids, electricity and the costs of the anaesthesia, were not taken into account.

Statistical analysis was carried out with the SPSS statistical package (IBM Company, Los Angeles, CA, USA). Continuous variables were expressed as median (range) and were compared using the Mann-Whitney U-test. For categorical variables, comparisons were made using chi-square or Fisher's exact tests, when appropriate.

Results

From June 2010 to January 2012, 40 patients underwent a SILC [25 women and 15 men, median age: 47.5 years (25–92)] and 37 patients underwent a CLC. Demographic characteristics of patients undergoing a SILC or CLC were similar in both groups as shown in Table 1.

Table 1.

Demographic characteristics of patients undergoing a single incision laparoscopic cholecystectomy and standard laparoscopic cholecystectomy

	SILC	Standard laparoscopy	P
	(n = 40)	(n = 37)
Gender (F/M)	25/15	25/12	0.822
Median age (year) (range)	47.5 (25–92)	52 (24–86)	0.456
Median BMI (kg/m2) (range)	24.4 (17.6–36.2)	26.2 (19–35)
ASA (I/II/III)	22/15/3	18/14/5
Previous abdominal surgery, n	17	23	0.113
Surgical indication, n
Gallstones	31	26	0.653
Gallbladder polyps	2	0	0.542
Previous episode of gallstone migration	4	6	0.548
Previous episode of biliary pancreatitis	3	5	0.554

SILC, single incision laparoscopic cholecystectomy; BMI, body mass index; ASA, American Society of Anesthesiologists physical status score.

The surgical results of both the SILC and CLC groups were also compared and were similar (Table 2). However, post-operative complications were exclusively reported in the SILC group including two incisional hernias. There were no conversions to open surgery. In the SILC group, an additional trocar placement was necessary in 16 patients (one additional trocar: n = 11; two additional trocars: n = 5). These were needed for better exposition and never for acute bleeding. Post-operative complications included respiratory distress after gastric fluid inhalation, in a patient who was treated by antibiotics during ICU hospitalization, two incisional hernias and one stone migration. No biliary leakage or bile duct injury were reported.

Table 2.

Surgical results for patients undergoing a single incision laparoscopic cholecystectomy and standard laparoscopic cholecystectomy

	SILC	Standard laparoscopy	P
	(n = 40)	(n = 37)
Median duration of surgery (min) (range)	70 (24–110)	70 (24–90)	0.665
Additional trocar placement, n	16	0	<0.0001
Median number of additional trocars (range)	1 (1–2)	–	–
Conversion to open surgery, n	0	0	–
Peri-operative morbidity, n	7	6	1.000
Gallbladder perforation	5	2	0.445
Haemorrhage	2	4	0.465
Post-operative morbidity, n	4	0	0.125
Incisional hernia	2	0	0.536
Respiratory distress	1	0	1.000
Gallstone migration	1	0	1.000
Ambulatory surgery, n	19	19	0.852
Median post-operative stay (day) (range)	1 (0–17)	0 (0–11)	0.554

SILC, single incision laparoscopic cholecystectomy.

The median post-operative pain scores at hospital discharge and at the initial post-operative visit were similar in both groups (P = 0.298 and P = 0.552, respectively). The median quality of life at the initial post-operative visit and the median cosmetic satisfaction at initial post-operative were similar in both groups (P = 0.236 and P = 0.454, respectively). The median time to return to work and to return to moderate physical activity were also similar in both groups (P = 0.625 and P = 0.421, respectively). Post-hospitalization outcomes for patients undergoing SILC and CLC are shown Table 3.

Table 3.

Post-hospitalization outcomes for patients undergoing a single incision laparoscopic cholecystectomy

	SILC	Standard laparoscopy	P
	(n = 40)	(n = 37)
Median postoperative pain scores at hospital discharge (VAS) (range)	5 (0–10)	3 (0–8)	0.298
Localization of the pain at hospital discharge
Right upper quadrant, n	15	–	–
Single incision, n	12	–	–
Shoulders, n	7	–	–
Other, n	6	–	–
Median pain at the initial post-operative visit (VAS) (range)	0 (0–7)	0 (0–5)	0.552
Localization of the pain at initial post-operative visit
Right upper quadrant, n	2	–	–
Single incision, n	1	–	–
Shoulders, n	0	–	–
Other, n	3	–	–
No pain, n	34	–	–
Median quality of life at initial post-operative visit (VAS) (range)	10 (6–10)	10 (5–10)	0.236
Median cosmetic satisfaction at initial post-operative visit (VAS) (range)	10 (5–10)	10 (5–10)	0.454
Median time to return to work (day) (range)	15 (3–30)	12 (1–45)	0.625
Median time to return to moderate physical activity (day) (range)	15 (1–42)	10 (7–25)	0.421

SILC, single incision laparoscopic cholecystectomy; VAS, 10-point visual analogue scale.

The median cost related to the duration of surgery did not differ significantly between the SILC and CLC groups (P = 0.625) (Table 4). The median cost of hospital stay was also similar in both groups (P = 0.932). The median global cost was superior in the SILC group also it did not reach statistical significance (P = 0.541).

Table 4.

Cost analysis of patients undergoing a single incision laparoscopic cholecystectomy and standard laparoscopic cholecystectomy

	SILC	Standard laparoscopy	P
	(n = 40)	(n = 37)
Median cost related to duration of surgery (€) (range)	233 (133–367)	233 (80–300)	0.625
Median cost of hospital stay (€) (range)	1604 (1429–27268)	1429 (1429–17644)	0.932
Median global cost (€) (range)	2169 (2002–28008)	1722 (1579–17874)	0.541

SILC, single incision laparoscopic cholecystectomy.

Discussion

In order to enhance the benefits of laparoscopic surgery, surgeons in recent years have attempted to use more minimally invasive surgical techniques. Single incision laparoscopic surgery was developed for this purpose in different surgical areas.²⁶ In the unit, single incision laparoscopic surgery is developed for various procedures and this approach is now routinely used.^27,28 Laparoscopic cholecystectomy initially seemed to be an ideal procedure to develop single incision laparoscopic surgery and the use of this approach was started in 2009. After a preliminary period, a standardized SILC procedure was developed and has been used in selected patients since 2010.

The first main finding of this series was the important rate of SILC procedures that required additional trocar placement (40%) in contrast with the 10% frequently reported in the literature¹⁰ but in accordance with the 66% reported by Ma et al.¹³ Indeed, in spite of an important experience in four-port laparoscopic cholecystectomy^1,25 and laparoscopic liver surgery^22,23,24 and a learning curve period of 1 year, technical difficulties are still encountered when performing a SILC. The use of a flexible laparoscope system and double-curved graspers that avoid swordplay between the instruments has facilitated the procedure but still does not guaranty that the surgery will be performed using a single incision, even in selected patients. The nature of single-incision laparoscopic surgery means that triangulation is not possible. In some procedures such, as a sleeve gastrectomy, the dissection is performed through an anterograde approach and thus is particularly adapted to single incision laparoscopic surgery.^27,28 During a laparoscopic cholecystectomy, the dissection of the anterior and posterior part of Calot's triangle is crucial and requires triangulation that is not currently possible by SILC. Indeed, four instrument channels do not allow moving freely using three instruments and an optical system at the same time.

Interestingly, technical difficulties did not affect the intra- and post-operative outcomes which were comparable between both groups (Table 2) as frequently reported in the literature.¹⁰ A recent review of the literature advocated that SILC could be associated with a higher incidence of bile duct injuries.²⁹ The authors identified an increased bile duct injury rate of 0.72% after a SILC compared with the historic rate of 0.4% to 0.5% associated with a CLC. Considering the rarity of this complication, in order to confirm such a difference, a prospective study would require, on the basis of 80% power at a 5% significance level, approximately 900 patients in both groups. Although the incidence of bile duct injury may be considered low, the prevalence is high given the frequency with which a cholecystectomy is performed. Thus, a precise monitoring of the development of this technology should be performed as advocated by Connor.³⁰ In this series, no bile duct injury was reported; however, a rigorous selection of patients for SILC could have hidden this risk. Another interesting finding was the incidence of incisional hernias (n = 2) within the SILC group. Two controlled trials have reported port site hernias exclusively after SILC,^13,16 although the small number of patients in those studies and the low incidence of this complication does not allow us to draw any conclusion. A series of large multicentre randomized controlled trials are still required to prove the efficacy and safety of SILC especially in comparison with the more challenging mini-laparoscopy.

In this series, the cosmetic satisfaction was similar regardless of the approach used. A recent study reported pre-operative patient preferences to SILC or CLC after they were shown post-operative images and after information using published objective data.³¹ Interestingly, after an initial preference for SILC when a cosmetic appearance was presented, the majority of patients chose CLC after being informed of the contemporary outcome. In spite of a possible superiority of SILC regarding cosmetic, others benefits of this technique are still unclear.

Cost considerations must also be taken into account when considering the merits of SILC. In this series, the global cost was slightly higher in the SILC group. Two previous studies have reported similar operative costs associated with SILC compared with CLC.^32,33The lower cost efficiency of SILC seems to be mainly a result of the price of the multiport device. However, this may change in the future and, on balance, is unlikely to limit this approach.

The standardization of SILC is possible. However, the important rate of additional trocar placement and a disturbing rate of incisional hernias clearly indicated the need for further large randomized studies.

Conflicts of interest

None declared.