Abstract
Objective
Intracorporeal reconstruction of the digestive tract is technically challenging. The V-Loc 180 wound closure device (Covidien) is a self-anchoring unidirectional barbed suture that obviates the need for knot tying. The aim of this prospective cohort study was to investigate the use of the novel suture in gastrointestinal enterotomy closure.
Methods
The subjects comprised patients with malignant disease who were scheduled to undergo laparoscopic gastrectomy with curative intent. The barbed suture was used to close the entry hole for the linear stapler during intracorporeal reconstruction following laparoscopic gastric resection. The primary endpoint was the proportion of patients who developed anastomotic leakage at the site where the barbed suture was applied.
Results
Between July 2012 and March 2015, 242 patients were enrolled. Of 362 anastomoses, the enterotomy hole at 256 sites was closed using the barbed suture. These 256 sites consisted of 95 gastroduodenostomies, 25 gastrogastrostomies, 13 gastrojejunostomies, 90 jejunojejunostomies, 17 esophagojejunostomies and 16 primary closures of the stomach following local gastric resection. There were no anastomosis-related complications, conversion to usual sutures, mechanical closure of the entry hole and reoperation due to adhesive obstructions or mortality over a median follow-up period of 17.8 months.
Conclusions
The use of the unidirectional barbed absorbable suture for gastrointestinal closure is safe and effective in laparoscopic gastrectomy.
Keywords: gastric cancer, intracorporeal anastomosis, laparoscopic gastrectomy, barbed suture
Introduction
Since laparoscopy-assisted distal gastrectomy was first reported by Kitano et al. in 1994 (1), the use of laparoscopic gastrectomy (LG) for cancer has been increasing rapidly and gaining popularity worldwide because it is associated with earlier patient recovery compared with open surgery (2–9). Moreover, improvements in instruments and laparoscopic techniques have permitted completely laparoscopic gastric resections with intracorporeal digestive reconstruction (10–14). Other investigators and our group have demonstrated the feasibility, safety and efficiency of totally laparoscopic gastrectomy (TLG), even with a relatively prolonged operating time (10,12,15). However, TLG has the disadvantages of technical difficulties in intracorporeal anastomosis and additional costs associated with the use of linear stapler cartridges (10). In addition, intracorporeal suturing and knot tying for anastomoses is one of the most tedious and time-consuming procedures in laparoscopic digestive surgery. It requires a safe and reproducible technique because most of the morbidity and mortality after digestive surgery are caused by leaks and fistulas.
Barbed sutures have recently been proposed to facilitate laparoscopic suturing. One of these novel sutures, the V-Loc 180 (Covidien, Mansfield, MA) consists of a barbed absorbable thread armed with a surgical needle at one end and a loop at the other end, which is used to secure the suture (Fig. 1). The barb and loop end make it possible to approximate the tissues without the need to tie surgical knots. The V-Loc 180 closure device is a unidirectional barbed variant of the absorbable copolymer polyglyconate (Maxon, Covidien). It has the same material and degradation properties as a Maxon (monofilament polyglyconate) suture, and its tissue closing strength is approximately 50% at 30 days, with complete absorption in 180 days. Although etching the barbs reduces the core diameter of these sutures, they have been sized according to their postetching diameter, and the 3-0 V-Loc suture has the same tensile strength as a 3-0 Maxon suture. A loop at the end of the suture can be used for knotless suturing, and the first 2 cm of the suture lacks barbs to allow throws to be readjusted before the barbs are engaged (Fig. 1).
Figure 1.
A 30 cm 3-0 V-Loc™ 180 suture on a V-20 needle (26 mm tapered): (a) there are no barbs in the first 2 cm of the suture, permitting readjustment of the throw without adverse effects, and a loop at the other end for passing the needle to secure the suture; (b) a close-up of the unidirectional barbed suture; (c) micrograph of the laser-etched barbs.
Recently, investigators have described numerous techniques for intracorporeal reconstruction in an attempt to improve surgical efficiency and invasiveness (13,16–19). We previously described our technique and initial experience from intracorporeal staple-conserving, delta-shaped gastroduodenostomy after distal gastrectomy in 2011, including the first use of barbed sutures for gastrointestinal suturing (20). There are some reports on the use of barbed sutures in digestive surgery to date, but there have been no prospective reports of bowel anastomosis in laparoscopic gastric surgery for malignant disease (21–24).
This prospective study aimed to investigate the safety and feasibility of the knotless, unidirectional barbed suture (V-Loc 180) for intracorporeal reconstruction of the digestive tract after LG for cancer.
Patients and methods
Study design and eligibility criteria
This prospective, single-center, single-arm, observational study was designed to evaluate the safety of the V-Loc during intracorporeal anastomoses in LG in terms of the incidence of anastomotic leakage. The study protocol was approved by the Ethical Committee on Clinical Investigation of Osaka Medical College Hospital and also registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), identification number UMIN 000008365.
The eligibility criteria for this study were as follows: (i) LG scheduled with curative intent; (ii) intracorporeal reconstruction scheduled by either functional end-to-end anastomosis or isoperistaltic side-to-side anastomosis using a linear stapler in LG; (iii) a patient aged over 20 years; (iv) no past history of surgery to the upper abdomen except laparoscopic cholecystectomy for gallstones; (v) an Eastern Cooperative Oncology Group performance status (ECOG PS) of either 0 or 1; (vi) acceptable major organ function based on laboratory data, and surgery can be tolerated; (vii) informed written consent to participate in the study obtained from the patient.
The exclusion criteria for this study were as follows: (i) women who are pregnant/possibly pregnant or breastfeeding; (ii) patients who are continuing to use a systemic steroid preparation (oral or intravenous); (iii) patients with poorly controlled diabetes mellitus (HbA1C > 8.0); (iv) patients who are allergic to nickel chrome (as specified in the package insert); (v) patients with psychiatric disorders or psychiatric symptoms and who are judged to have difficulty participating in the study; (vi) other patients who are considered not suitable for participation in this study by the physician in charge.
Indications for LG for cancer at our institute include the following: (i) all tumors confined to the muscularis propria and not amenable to endoscopic mucosal resection, with lymph node involvement limited to N1; (ii) patients requiring salvage surgery after incomplete endoscopic resection; (iii) patients over 80 years of age with advanced gastric cancer; (iv) enrolled patients for the randomized controlled trial to evaluate laparoscopic versus open surgery for advanced gastric cancer (UMIN 000003420: JLSSG0901: Adv.GC-LAP/OPEN, PII/III).
Operative procedure
The type of laparoscopic gastric resection was determined according to the tumor location, tumor size, depth of invasion and clinical nodal status based on Japanese treatment guidelines (25,26). Distal gastrectomy (DG) is indicated for distal and middle third gastric cancers in which tumor margins of at least 2 cm for early and 3–5 cm for advanced lesions are possible. Some patients with very early disease may undergo a more limited resection such as pylorus-preserving gastrectomy (PPG) (13). PPG is indicated for lesions of the body of the stomach limited to the mucosa (<4 cm in diameter) or submucosa (<2 cm in diameter) with no evidence of lymph node involvement, for which a sufficient distal remnant to permit an antral cuff of at least 4 cm for gastrogastric anastomosis is necessary. Proximal gastrectomy (PG) is indicated for early gastric cancer in the upper third of the stomach with no evidence of lymph node involvement. Total gastrectomy (TG) is indicated for locally advanced proximal lesions or multiple lesions for which the distal stomach cannot be preserved. Finally, local resection of the stomach (LR) is indicated for submucosal tumors with suspected malignancy.
The reconstruction method after each type of gastrectomy is as follows: (i) after DG, Billroth I reconstruction by the delta-shaped method was performed in principle (Fig. 2) (20), but Roux-en-Y reconstruction, which incorporated totally mechanical gastrojejunostomy with intracorporeal side-to-side jejunojejunostomy, was applied for patients with a small remnant stomach (Fig. 3) (14,26–28); (ii) after PPG, Billroth I gastrogastrostomy by the delta-shaped method was performed; (iii) after TG, Roux-en-Y reconstruction, which consists of intracorporeal side-to-side esophagojejunostomy and intra- or extracorporeal side-to-side jejunojejunostomy, was performed; (iv) after PG, the double-tract method, which consists of intracorporeal side-to-side esophagojejunostomy and extracorporeal gastrojejunostomy and jejunojejunostomy via an umbilical minilaparotomy, was performed; (v) after LR, a two-layered continuous technique for gastrotomy closure using a barbed suture was performed.
Figure 2.
(a) Insertion of an anvil fork into the duodenal stump, with each fork positioned to join the posterior walls together; (b) V-shaped stapler entry hole for the stapler between the stomach and the duodenum; (c) step 1 of the intracorporeal suture closure of the common enterotomy hole showing the full-thickness inner layer closure using a knotless unidirectional barbed suture, starting the corner of the greater curvature; (d) step 2 of the intracorporeal suture closure of the common enterotomy showing the second seromuscular layer closure using the same suture, returning from the lesser curvature; (e) completed delta-shaped gastroduodenostomy using a knotless unidirectional barbed suture.
Figure 3.
Intracorporeal Roux-en-Y reconstruction after distal gastrectomy consisted of totally mechanical gastrojejunostomy and side-to-side jejunojejunostomy.
Our intracorporeal anastomosis consisted of either isoperistaltic or antiperistaltic side-to-side anastomosis using a linear stapler and closing the entry hole of the stapler using the knotless, unidirectional barbed suture. All intestinal openings were closed with a continuous two-layer suture. Using a 15- or 30 cm 3-0 V-Loc 180 suture on a V-20 needle (26 mm tapered) for both layers, the full-thickness inner layer closure was started from the corner of the opening hole toward the other corner with a continuous technique. Once the full-thickness layer was complete, the second seromuscular layer was commenced, returning toward the starting point using the same barbed suture. After the last stitch, the suture was simply cut without the need for any knots to anchor the last throw (Fig. 2). However, care should be taken that the suture end was cut as short as possible because there remains a concern that the free tail of the barbed suture could generate harmful effects.
Postoperative oral intake protocol
In the 33-month study, for the first 9 months (from July 2012 to March 2013), patients were allowed to drink only water on postoperative day (POD) 3. Oral intake was started on POD 4, advancing in three steps to regular food on POD 7. However, in the following 24 months (from April 2013 to March 2015), because we started the prospective clinical trial on the enhanced recovery after surgery (ERAS) protocol in the perioperative care (UMIN 000011572), half of the patients were started on sips of water on POD 1. Oral intake was started on POD 2 with the same systematic oral intake as in the aforementioned protocol.
Endpoints
The primary study endpoint was the incidence of postoperative anastomotic leakage at the site where V-Loc 180 was applied. The secondary endpoints were the conditions of the suturing site (status of hemostasis and frequency/severity of damage to serous membranes), location suture failure, anastomotic stenosis, anastomotic hemorrhage, duration of the suturing, amount of surgical suture used, amount of hemorrhage, duration of surgery, incidence of intraoperative and postoperative adverse events, and duration of hospitalization (days). In this trial, adverse events were classified on the basis of the Common Terminology Criteria for Adverse Events version 4.0, where a Grade 1 or more anastomotic leakage was diagnosed radiologically and recorded regardless of its clinical significance.
Statistical analyses for two-group comparisons were performed applying Student's t-test for continuous variables using JMP for Windows, version 11 (SAS Institute Inc.).
Results
Between July 2012 and March 2015, 242 patients were registered in the trial. The patients' characteristics and surgical procedures are summarized in Tables 1 and 2. The mean patient age was 69.4 years (range, 29–92 years). Of the 242 patients, 162 were men and 80 were women. The indications were as follows: 219 gastric cancers, 16 gastric submucosal tumors (SMTs) (13 gastrointestinal stromal tumors and 3 leiomyoma), 1 metastatic gastric tumor from lung cancer, 1 neuroendocrine tumor and 5 duodenal bulb tumors. Comorbidities were present in 148 cases (61.1%).
Table 1.
Patient characteristics
| No. of patients | 242 |
| Age, years (range) | 69.4 ± 10.3 (29–92) |
| Gender, male/female | 162/80 |
| Body mass index, kg/m2 (range) | 22.5 ± 3.1 (14.8–30.8) |
| Indications | |
| Gastric cancer (Pathological stage I/II/III/IV)a | 219 (172/24/22/1) |
| SMT of the stomach | 16 |
| Metastatic gastric tumor | 1 |
| Gastric carcinoid | 1 |
| Duodenal tumor | 5 |
| ASA Grade (1/2/3/4/5) | 84/112/44/2/0 |
| Co-morbidity (%) | 148 (61.1) |
| Hypertension | 91 (37.6) |
| Diabetes | 41 (16.9) |
| Cardiovascular disease | 34 (14.0) |
| Cerebrovascular disease | 13 (5.4) |
| COPD | 16 (6.6) |
| Dyslipidemia | 19 (7.9) |
| Miscellaneous | 37 (15.3) |
SMT, submucosal tumor; ASA Grade, score of the American Society of Anesthesiology; COPD, chronic obstructive pulmonary disease.
Continuous variables are presented as the mean ± standard deviation.
aStaging was performed according to the seventh edition of the Union Internationale Contre le Cancer classification.
Table 2.
Operative variables
| Type of gastrectomy and reconstruction | No. (%) of patients | Operative time, min | Estimated blood loss, ml |
|---|---|---|---|
| DG and Billroth Ia | 95 (39.2) | 233.3 ± 56.8 (115–315) | 44.1 ± 61.3 (5–250) |
| DG and Roux-en-Y | 67 (27.7) | 253.7 ± 41.6 (175–330) | 19.6 ± 13.9 (5–50) |
| DG and Billroth II with Braun anastomosis | 6 (2.5) | 237 ± 85.6 (170–354) | 63.3 ± 123.8 (5–410) |
| PPG and gastrogastrostomy | 25 (10.3) | 264 ± 71.6 (130–345) | 15.0 ± 4.5 (10–20) |
| LR and Hand-sewn closure | 16 (6.6) | 127.2 ± 59.0 (85–229) | 12.5 ± 7.5 (5–20) |
| TG and Roux-en-Yb | 19 (7.8) | 341.6 ± 48.7 (275–390) | 28.3 ± 15.4 (15–50) |
| PG and Double-tractc | 14 (5.8) | 290 ± 81.7 (155–432) | 48.6 ± 63.2 (5–220) |
DG, distal gastrectomy; PPG, pylorus-preserving gastrectomy; LR, local gastric resection; TG, total gastrectomy; PG, proximal gastrectomy.
Continuous variables are presented as the mean ± standard deviation.
aThere were five patients with gallstones who underwent cholecystectomy simultaneously.
bThere was a patient who underwent cholecystectomy for gallstones simultaneously.
cThere were three patients with gallstones who underwent cholecystectomy simultaneously.
All 242 gastrectomies with digestive reconstructions were performed by one senior surgeon (n = 68) and five training surgeons (n = 174) and successfully completed using pure laparoscopic techniques as follows: 168 patients (69.4%) underwent DG, whereas the remaining procedures consisted of 25 (10.3%) PPGs, 16 (6.6%) LRs, 19 (7.8%) TGs and 14 (5.8%) PGs. The method of intracorporeal anastomosis used in the DG operations were Billroth I reconstruction in 95 cases, Roux-en-Y reconstruction in 67 cases and Billroth II reconstruction with Braun anastomosis in 6 cases.
Of the 362 anastomoses of the digestive tract in 242 cases, 256 intracorporeal anastomoses with the use of the knotless unidirectional barbed suture in gastrointestinal enterotomy closure were performed. The remaining 106 anastomoses consisted of 67 intracorporeal mechanical gastrojejunostomies after DG, 16 esophagojejunostomy using the double stapling technique after 9 TGs and 7 PGs, 7 gastrojejunostomy after PG and 16 extracorporeal jejunojejunostomies via an umbilical minilaparotomy after 9 TGs and 7 PGs.
The intracorporeal suture closure of the common enterotomy hole for the stapler using the barbed suture included 95 gastroduodenostomies, 25 gastrogastrostomies, 13 gastrojejunostomies, 90 jejunojejunostomies (73 after DG, 10 after TG and 7 after TG) and 17 esophagojejunostomies (Table 3). For the remaining 16 sites, primary closure was achieved using V-Loc 180 devices following LR in patients with SMTs of the stomach (Table 3). There was no conversion to mechanical closure using linear staplers or to conventional knotted sutures in all cases.
Table 3.
Site of V-Loc 180 suturing for closure of the enterotomy
| Type of anastomosis | No. of anastomosis | Length of enterotomy for suture, cm (range) | V-Loc 180 suturing time, min (range) |
|---|---|---|---|
| Gastroduodenal anastomosis | 95 | 2.6 ± 0.6 (1.5–4.0) | 16.4 ± 4.1 (10.8–28.1) |
| Gastrogastric anastomosis | 25 | 3.1 ± 0.6 (2.5–4.0) | 16.0 ± 3.5 (11.3–20.5) |
| Gastrojejunal anastomosis | 13 | 2.8 ± 0.3 (2.5–3.0) | 16.0 ± 6.9 (9.1–23.0) |
| Jejunojejunal anastomosis | 90 | 1.8 ± 0.4 (1.5–3.0) | 12.2 ± 6.7 (5.8–26.5) |
| Esophagojejunal anastomosis | 17 | 2.5 ± 0.7 (2.0–3.5) | 19.3 ± 9.4 (8.4–35.0) |
| Closure of the stomach | 16 | 3.8 ± 1.3 (2.0–5.5) | 18.4 ± 3.9 (11.0–22.2) |
Continuous variables are presented as the mean ± standard deviation.
Regarding the process of learning of using the novel suture, the learning curve analysis for suturing time at the gastroduodenostomy sites, which was the most common procedure, showed stabilization at six cases (P < 0.001) (Fig. 4). We did not observe any complications related to technical failure in the learning period by training surgeons. The morbidity and mortality data are shown in Table 4. There were neither surgical complications, such as gastrointestinal tears or injuries during the suture, nor a need for blood transfusions during surgery. In terms of postoperative morbidities, anastomosis-related complications, including Grade 1 or greater anastomotic leakage, were not observed in the present series. Grade 2 or greater pancreatic fistula formation was observed in seven patients. Although one of these patients had postoperative hemorrhage associated with pancreatic inflammation, this case was successfully treated by endovascular coiling. Grade 2 gastric stasis was observed in three patients who underwent PPG. Grades 3 or greater postoperative bleeding were observed in two patients, and one patient was performed re-operation due to a hemoclip slipped off of the right gastroepiploic vein. Grade 2 or 3 pulmonary infection was observed in four elderly patients, and Grade 3 enterocolitis was observed in 2 elderly patients who underwent DG.
Figure 4.
Time taken to perform an intracorporeal suture closure of the gastroduodenostomy for each of seven surgeons.
Table 4.
Morbidity and mortality
| No. (%) of patients (n = 242) | |
|---|---|
| Morbidity | |
| Intraoperative | 0 |
| Postoperative | 17 (11.2) |
| Anastomotic leakage | 0 |
| Anastomotic bleeding | 0 |
| Anastomotic stricture | 0 |
| Anastomotic ulcer | 0 |
| Pancreatic fistula | 7 (2.9) |
| Intraabdominal abscess | 5 (2.0) |
| Mechanical obstruction | 0 |
| Paralytic ileus | 2 (0.8) |
| Gastric stasis | 3 (1.2) |
| Intraabdominal bleeding | 2 (0.8) |
| Wound infection | 5 (2.0) |
| Pulmonary infection | 4 (1.6) |
| Enterocolitis | 2 (0.8) |
| Mortality | 0 |
A liquid diet was reintroduced after a median of 4 days (range, 1–20 days), and the median postoperative hospital stay was 10 days (range, 7–41 days). Among 78 patients who were treated according to the ERAS protocol, the completion rate of the pathway was 88.5% (69 out of 78 cases). There was no mortality in this series after a median follow-up of 17.8 months (range, 5.7–38.2 months), whereas in the postoperative third month, an 88-year-old patient was readmitted because of a relapse of enterocolitis.
Discussion
Although the use of laparoscopic surgery for gastric disease has increased over the past two decades, a pure laparoscopic technique, consisting of both gastric resection and reconstruction, remains technically demanding. In particular, laparoscopic suturing is a technically challenging procedure even for experienced general surgeons because it requires specific advanced skills (29,30). Additionally, its complications are responsible for a large proportion of the ensuing mortality and morbidity.
It has been suggested that a knotless barbed suture should make laparoscopic suturing easier. To date, the efficacy and safety of this novel suture in gynecologic (31–35), urologic (36–38) and orthopedic surgery (39) have been reported. With respect to digestive surgery though, only a few studies, including our 2011 report of the first use of barbed sutures in gastrointestinal anastomoses, have proven the safety and suitability of barbed sutures in terms of anastomotic leakages or stenosis, but there have been no prospective studies for bowel anastomosis following LG for malignant disease. Using a porcine model, Demyttenaere et al. (40) demonstrated closure equivalence with standard absorbable monofilament sutures (Maxon) in terms of burst strength and histopathologic inflammatory response at 3, 7 and 14 days post-surgery, but faster anastomosis times. Using deceased individuals, Nemecek et al. (41) reported that the bursting strength of the suture created with the V-Loc closure device was better in the small intestine and comparable in the colon and the stomach compared with those created using monofilament suture material.
This prospective cohort study aimed to estimate the safety and feasibility of knotless unidirectional barbed sutures for closure of the intestinal opening after side-to-side mechanical anastomosis in a single-center consecutive series of patients who underwent TLG for tumor excision. Our hypothesis was that barbed sutures could potentially improve the efficiency of the intracorporeal reconstruction of the digestive tract after laparoscopic gastric resection, with less time needed to suture as they resist slippage and preclude the requirement for constant traction. In addition, they could reduce costs by closing the entry hole of the stapler instead of stapling.
In this study, we presented the clinical outcomes of 242 consecutive eligible patients who underwent laparoscopic gastric surgery using the knotless barbed suture. In our series, no complications occurred as a direct result of the suture, including leaks or stenosis at the anastomotic sites. Furthermore, we did not observe any complications related to technical failure in the learning period by training surgeons. The feasibility and safety of this procedure was confirmed because it was performed by both an experienced surgeon and training surgeons without any adverse events.
The overall mortality and morbidity rates were consistent with those obtained using conventional techniques in digestive surgery (19). The short-term safety was confirmed as well as the absence of stomal stenosis and bowel obstruction after surgery over a median follow-up of 17.8 months (range, 5.7–38.2 months). The findings of these studies led us to believe that the on-label use of this FDA-approved material for gastrointestinal closure was justified. Because the novel suture could facilitate sutures in laparoscopy, it should be preferred as suture material. This recommendation, however, must be reassessed in further clinical studies comparing the intracorporeal suture closure of the gastrointestinal enterotomy using the novel sutures with other closing methods using general absorbable sutures or linear staplers.
The barbed, absorbable suture appears to be ideal for intracorporeal laparoscopic suturing. First, the looped end permits rapid tethering of the suture at one end without a knot. Second, once pulled tight, the suture does not slip, obviating the need for its repeated tightening along the length of its course. Third, at the end of the closure or anastomosis, the suture is simply cut, without the need for any knots to anchor the last throw. Finally, the barbed suture allows for multiple points of fixation along the closure of the bowel, compared with only two points of fixation at the knots with traditional suture. This should permit a greater distribution of tensile strength along the wound and increase the surface area of adhesion between the tissues. Consequently, the knotless, unidirectional barbed suture reduced the time required to close the entry hole compared with conventional surgical suture with intracorporeal knots (22–24).
We use a two-layered continuous technique for enterotomy closure. Starting from the corner of the stapling line and using a long enough suture for both layers, the inner full-thickness layer is closed toward the other corner by a continuous technique. We use a 30-cm V-Loc closure device for the gastroduodenal anastomosis and a 15-cm V-Loc closure device for the jejunojejunal anastomosis. As it is difficult to control the long suture inside the body, we prefer to bring it out through the 12 mm right hand operative port before creating the next stitch. Once the inner layer is complete, the second seromuscular layer is commenced, returning towards the starting point using the same suture.
There remains a concern that the free tail of the barbed suture could result in intestinal obstruction. This complication has been described in three case reports after laparoscopic gynecologic surgery (42–44). All three case reports described initial laparoscopic pelvic surgery using barbed sutures including promontofixation, sacral colpopexy and vaginal cuff closure. All three patients were re-explored, revealing a high-grade obstruction due to the tail of the barbed suture. Two of these patients had volvulus and the third had an internal hernia created by the barbed tail entrapping the small bowel mesentery. The reports of two studies commented that the tail of the suture was approximately 4 cm in length. With the hope of overcoming the drawbacks of adhesive obstructions, we cut the suture ends as short as possible, and consequently no patients developed such an adverse event in our study. If looseness at the end site is a concern, then the surgeon may elect to take an additional pass through tissue and cut the suture flush with the bowel wall.
Conclusion
In conclusion, the use of knotless unidirectional barbed sutures in gastrointestinal enterotomy closure is safe and reproducible in laparoscopic gastric surgery. Its safety was confirmed, as none of the patients developed anastomosis-related complications, such as leakages, hemorrhage or stenosis. However, further clinical studies must be awaited.
Funding
This study was partially funded by Covidien, and registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), identification number UMIN 000008365.
Conflict of interest statement
None declared.
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