Comparison of Laparoscopic Sleeve Gastrectomy Bleeding and Leakage Rates in Four Staple-Line Reinforcement Methods: A Prospective Observational Study

Abstract

Introduction:

Staple-line bleeding and gastric leakage are the most serious complications of laparoscopic sleeve gastrectomy (LSG). Reinforcement of the staple line is reported to be a method to reduce these complications rates, but the question of which method is preferable is a matter of controversy in the literature. In this study, we compared different staple-line reinforcement methods to assess their efficiency in preventing staple-line bleeding and leakage.

Materials and Methods:

Two hundred patients eligible for LSG were enrolled in the study and randomized into five groups based on the reinforcement method used during surgery: no reinforcement, oversewing using 3-0 polydioxanone (PDS) suture, oversewing using 4-0 barbed absorbable closure device (V-Lock), fibrin sealant glue, and buttress material. Intraoperative and postoperative complications were recorded and analyzed. Differences were considered statistically significant for P < .05.

Results:

The no-reinforcement group showed higher bleeding rates (20%), although only 2.5% of the patients required reintervention. All groups using staple-line reinforcement showed better outcomes in bleeding rates (P < .05). No statistically significant differences were observed among the groups in terms of the leakage rate, reintervention rate, intraoperative complications, and operative times.

Conclusion

: The reinforcement of the staple line decreased the bleeding rate in sleeve gastrectomy but did not affect the gastric leakage rate.

Introduction

Laparoscopic sleeve gastrectomy (LSG) is the most widely performed type of bariatric surgery worldwide.¹ Many studies have shown that LSG promotes weight loss that is both effective and long-lasting, as well as the reduction of comorbidities.^2–3 The most serious complications of LSG are staple-line leaking and bleeding. Both complications have an unfavorable impact on patient's clinical outcomes and health care costs.⁴ Many surgeons have attempted to reduce the leak and bleeding rates by using different methods to reinforce the gastric sleeve stapled line. In 2013, Parikh et al. collected data from 9991 LGS patients, concluding that reinforcement with absorbable material does not reduce the incidence of gastric leak.⁵

A systematic review by Gagner and Buchwald in 2014, including 88 studies and 8920 patients, evaluated the leak rate after LSG using different staple-line reinforcements. The absorbable polymer membrane (APM) staple-line reinforcement showed better outcomes than oversewing the staple line, using nonabsorbable bovine pericardial strip (BPS) reinforcement, or using no reinforcement.² A prospective randomized study in 2016 compared various reinforcement techniques with the simple section of the stomach without reinforcement, concluding that reinforcement only increased the operative times.⁶

In contrast, a recent study of 1000 patients by Coskun and Yardimci concluded that fibrin sealant is a reliable and useful tool to reinforce the staple line.⁷ The purpose of this prospective observational study was to compare no reinforcement stapled-line LSG to four reinforcement stapled-line methods: buttress material (EndoGIA™ reinforced reload with Tri-Staple™ technology; Medtronic), oversewing with 3-0 polydioxanone (PDS) suture (MIC 54; Ethicon Endo-Surgery), oversewing with a 4-0 barbed absorbable closure device (V-Lock 90; Medtronic), and the application of tissue fibrin sealant (Tisseel; Baxter).

Materials and Methods

Between July and September 2019 at Policlinico San Marco, “Italian Society of Bariatric Surgery and Metabolic Diseases” (SICOB) center of excellence for bariatric surgery (Corso Europa 7, 24040, Osio Sotto, Italy), we selected obese patients to participate in the study, which was approved by the local Institutional Review Board. Inclusion criteria were patient age >18, and a body mass index (BMI) over 40 kg/m² and BMI >35 kg/m² with obesity-related diseases according to the “International Federation for the Surgery of Obesity and Metabolic Disorders” and SICOB guidelines.⁸ Exclusion criteria were patients older than 65 years, previous bariatric procedures, “American Society of Anesthesiologists” classification IV or higher, previous major supramesocolic surgery, and a history of one or more bariatric surgeries.

The primary endpoint was the incidence of postoperative complications such as gastric leakage and/or bleeding of the stapled line. Bleeding events were considered if one or more of the following conditions occurred after finding hemoglobin loss: blood transfusion, reintervention, or increased hospitalization. An internal management protocol with a serial blood count is triggered whenever the postoperative hemoglobin value is <10.9 g/dL or there is a loss of hemoglobin >3 g/dL, the presence of hematic fluid in the abdominal drain (>500 mL), or symptoms of hemorrhagic shock. The Yates chi-square test was performed to determine whether the observed differences were statistically significant (P < .05).

Patients were randomized into five groups using a randomization sequence created in Excel 2016 (Microsoft): no stapled-line reinforcement with only bipolar hemostasis (Group 1); oversewing sutures with 3-0 PDS (Mic 54™; Ethicon) (Group 2); oversewing sutures with 4-0 V-Loc™ suture (Medtronic) (Group 3); stapled-line reinforcement with fibrin sealant glue application (Tisseel™; Baxter) (Group 4); and stapled-line reinforcement with APM buttress (Endo GIA™ Reinforced Reload with Tri-Staple Technology; Medtronic) (group 5). The patients received 40 mg of subcutaneous enoxaparin 12 hours before surgery and 4 weeks after surgery.

Surgical technique and postoperative management

The procedure was carried out by the same team of skilled bariatric surgeons. The dissection of the gastric greater curvature was carried out using a radiofrequency vessel-sealing device (Maryland LigaSure™; Medtronic). A 38F probe was used to calibrate the stomach section. The section was performed using multiple applications of a linear stapler (Signia Tri-Staple; Medtronic). In the no-reinforcement group (Group 1), only bipolar hemostasis was performed on the gastric staple line. In Groups 2 and 3, oversewing was performed only in the upper third of the staple line. In Group 4, fibrin glue was applied along the entire length of the staple line. In Group 5, the staple line was entirely performed using buttress material. The resected stomach was removed from a 15 mm trocar. No intraoperative leak tests were performed. A perigastric drain was then inserted.

The patients were mobilized on the first postoperative day (POD). The abdominal drain was removed on the second POD after upper gastrointestinal series with water-soluble contrast (Gastrografin™; Bracco Diagnostics, Italy). Patients were discharged on the third POD. A follow-up of 6 weeks was carried out for all patients to assess the occurrence of postoperative complications. Statistical analyses were performed using “IBM SPSS statistics” version 21.

Results

A total of 200 eligible patients who underwent LSG were enrolled in the study. Each group (five groups) consisted of 40 patients. A total of 125 patients were women and 75 were men. The average age was 47.9 years (range: 21–65 years), and the average BMI was 49.2 kg/m² (range: 38.6–58.3 kg/m²). The characteristics of the patients in the five groups were similar (Table 1). No statistically significant difference was found between the groups in terms of BMI and comorbidities (Yates chi-square test, P > .05). Moreover, the operative times were similar. There were no intraoperative complications (Table 2).

Table 1.

Preoperative Patient Characteristics

	Group 1 (n = 40)	Group 2 (n = 40)	Group 3 (n = 40)	Group 4 (n = 40)	Group 5 (n = 40)	Total (n = 200)
Sex
Males, n (%)	17 (42.5)	15 (37.5)	14 (35)	14 (35)	15 (37.5)	75 (37.5)
Females, n (%)	23 (57.5)	25 (62.5)	26 (75)	26 (75)	25 (62.5)	125 (62.5)
Mean age (years)	47.8	49.3	46.1	50.1	46.2	47.9
Mean BMI (kg/m²)	51.3	48.1	54.1	47.2	45.3	49.2
Hypertension, n (%)	9 (22.5)	5 (12.5)	12 (30)	6 (15)	5 (12.5)	37 (18.5)
Diabetes mellitus, n (%)	2 (5)	1 (2.5)	1 (2.5)	1 (2.5)	1 (2.5)	6 (3)
OSAS, n (%)	14 (35)	13 (32.5)	16 (40)	14 (35)	11 (27.5)	68 (34)

This table shows patient characteristics and comorbidities before the surgery.

BMI, body mass index; OSAS, obstructive sleep apnea syndrome.

Table 2.

Outcomes of Surgery

	Group 1 (n = 40)	Group 2 (n = 40)	Group 3 (n = 40)	Group 4 (n = 40)	Group 5 (n = 40)	Total (n = 200)
Mean operative time (minutes)	59	75	67	64	58	64.6
Intraoperative complications, n (%)	0	0	0	0	0	0
Bleedings, n (%)	8 (20)	1 (2.5)	0	0	0	9 (4.5)
Blood transfusion, n (%)	0	0	0	0	0	0
Leaks, n (%)	2 (5)	1 (2.5)	1 (2.5)	0	1 (2.5)	5 (2.5)
Reintervention, n (%)	1 (2.5)	0	1 (2.5)	0	1 (2–5)	3 (1.5)
Delayed discharge^a, n (%)	8 (20)	1 (2.5)	0	0	0	9 (4.5)
Costs per single surgery (€)	0	50	25	160	53

Group 1: no staple-line reinforcement; Group 2: reinforcement using a 3-0 PDS; Group 3: reinforcement using a 4-0 barbed absorbable closure device (V-Lock); Group 4: reinforcement using fibrin sealant glue (Tisseel); Group 5: reinforcement using absorbable polymer membrane buttress.

Patients discharged after the third postoperative day.

Patients in Group 1 underwent LSG without reinforcement, and hemostasis was achieved by bipolar coagulation of the stapled line. In this group, we found 8 cases (20%) of postoperative bleeding before the discharge day. Seven patients (87.5% of bleedings in this group) were treated conservatively without blood transfusion and were discharged between the fourth and sixth PODs (lowest hemoglobin range reached by patients was 7.9 to 9.5 g/dL); 1 patient required reintervention with surgical hemostasis but no need for blood transfusion and was discharged on the fifth POD.

In the same group, we found two postoperative leaks (5%): 1 case was diagnosed on the third POD, in which we performed esophagogastric endoscopic stent placement, and the other case was diagnosed on the seventh POD, in which we performed laparoscopy, intra-abdominal collection toilet, and gastric leak suture, with subsequent placement of esophagogastric endoscopic stent.

Group 2 consisted of patients who underwent LSG with oversewing sutures using a 3-0 PDS (Mic 54; Ethicon). In this group, we found 1 case (2.5%) of postoperative bleeding that was conservatively treated, and 1 case (2.5%) of gastric leak that was treated with CT scan-guided intra-abdominal collection drainage and endoscopic esophagogastric stent placement.

In Group 3, LSG stapled lines were reinforced with a 4-0 barbed absorbable closure device (V-Lock 90; Medtronic). We found postoperative leak in 1 patient (2.5%) on the eighth POD, which was treated with laparoscopy, abdominal toilet, and suture of the gastric leak, with subsequent placement of esophagogastric endoscopic stent.

Group 4 LSG staple lines were reinforced with 4 mL of fibrin sealant glue (Tisseel; Baxter). We had no postoperative complications in this group.

In Group 5, stapled-line reinforcement was performed using an APM buttress (Endo GIA Reinforced Reload with Tri-Staple Technology; Medtronic). We diagnosed 1 case (2.5%) of postoperative leak on the seventh POD, treated with laparoscopy, abdominal toilet, and endoscopic esophagogastric stent. In Groups 3, 4, and 5, no bleeding events were observed compared with Group 1 and the difference was statistically significant (P = .0091). The difference in bleeding rate between Group 2 and Group 1 was also statistically significant (P = .0338).

All patients treated with esophagogastric endoscopic stent placement underwent CT scan with water-soluble contrast on first POD, with resumption of oral feeding on second POD. The patients were discharged on the fifth POD and the esophagogastric stent was removed 4 weeks after placement, with complete resolution of gastric leak in all cases. No deaths or conversions to laparotomy occurred among the patients.

Discussion

The LSG is a safe and feasible surgery with results in terms of weight loss outcomes and weight-associated comorbidities, similar (if not superior) to other bariatric procedures.⁹ However, the long staple line in LSG has created particular concerns about the risk of leaks, which range from 0.7% to 5.7%.^9,10 Multiple studies over the last decade have sought to identify variables linked to a lower incidence of leaks, including bougie size, distance from the pylorus, surgeon expertise, and staple-line reinforcement.^—11–15

Studies have shown improved resistance of staple lines to pressure when buttressing materials are used and this result has been attributed to the possibility that the buttressing materials distribute tension over the entire staple line more than a single spot.^16–18 Although the importance of staple-line reinforcement is described in the literature, the subject is still controversial. Surgeons use different methods for staple-line reinforcement in LSG surgery; however, a definitive joint decision has not been reached. Consten et al. in 2004 reported that APMs reduce bleeding and leakage from staple line.¹⁹ In a 2012 meta-analysis, Choi et al. reported that staple-line reinforcement has advantages for preventing postoperative leakages and general complications.²⁰

On the contrary, a 2015 work by Timucin Aydin et al. found that the routine use of reinforcement methods (sutures, buttress, fibrin glue sealant) is not mandatory during LSG, suggesting that these methods increase the costs and the operating time of the surgery.²¹ A 2019 work by Pilone et al. comparing no staple-line reinforcement versus reinforcement with omentopexy with cyanoacrylate glue showed better results in terms of reduction of leaks and bleeding in the group of omentopexy and glue.²² A 2015 monocentric comparison of three different types of reinforcement (seromuscular suture, BPS, and APM) by Barreto et al. demonstrated significantly increased readmission and reoperation rates with increased leak rates with the use of BPS in LSG patients. The bleeding rate was not statistically different among the three reinforcement techniques.²³

A 2018 retrospective monocentric study by Guerrier et al. comparing suturing versus no reinforcement suggested that staple-line reinforcement does not provide significant leak reduction, but does reduce intraoperative staple-line bleeding. In addition, oversewing the staple line was associated with postoperative sleeve stenosis without added benefits.²⁴ The same results are reached by Taha et al. in a 2018 monocentric randomized comparison between staple-line oversewing versus no reinforcement.²⁵

In contrast, in a monocentric randomized-controlled trial including 920 patients undergoing LSG, Hany and Ibrahim compared the invagination of the staple line using absorbable V-Loc with no reinforcement. This study showed significantly better outcomes in the reinforced group.²⁶ Lee et al. reported that the usage of tissue fibrin adhesives was effective on reducing the risk of anastomosis leakage.²⁷ In a retrospective study with 74 patients, it was suggested that thrombin matrix is safe and can be an alternative to other techniques for LSG.²⁸

A 2020 systematic review by Gagner and Kemmeter including 148 articles and 40,653 patients compared five reinforcement options during LSG: no reinforcement oversewing (suture), nonabsorbable BPS, tissue sealant or fibrin glue (Seal), and APM. The review showed a significantly lower rate of bleeding using APM staple-line reinforcement than the others.²⁹

Our prospective observational study compared 5 groups of 40 patients who underwent LSG with different staple-line treatments: no reinforcement, oversewing 3-0 PDS suture, oversewing with 4-0 barbed absorbable closure device, application of fibrin sealant glue, and stapled buttressed APM.

Compared with no reinforcement, we observed no significant increase in the operative times, conversion to laparotomy, or intraoperative complications rates using any of the staple-line reinforcement techniques. Staple-line reinforcement showed better results in terms of bleeding rate, regardless of the technique used, with statistically significant results (P < .05, in all groups compared with no reinforcement). However, there was no statistically significant difference in terms of reintervention rates among groups, showing that in the no-reinforcement group, despite the increased bleeding rate, most of these events were minor but still negatively impacted hospitalization costs. A cost analysis was not performed because of the internal policy of the hospital.

However, the cost per surgery is reported in Table 2 using the regional average price of each material used. Although not statistically significant, we found better outcomes with fibrin sealant glue than with other reinforcement methods without any postoperative complications. In this study, we found no association between gastric leakage and bleeding (P > .05).

The main limitation of this study was the relatively small sample size of patients in each group. Further randomized-controlled studies are required to confirm the results of this study.

Conclusion

The results of this study showed a statistically significant reduction in the bleeding rate in patients who underwent LSG with a reinforcement technique compared with those who did not. No statistically significant difference was observed in leakage rate. Comparing the different reinforcement methods, we found better outcomes using fibrin sealant glue (Tisseel), although the difference was not statistically significant.

Footnotes

Authors' Contributions

F.D.C.: writing—review and editing, formal analysis, and visualization. G.C.C.: investigation and resources. M.U.: investigation, resources, and data curation. F.C.: investigation and resources. S.O.: conceptualization, writing—original draft, methodology, and supervision.

Disclosure Statement

No competing financial interests exist.

Funding Information

The author received no financial support for the research, authorship, and/or publication of this article.

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