Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Study Overview
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Brief Summary
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Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be used to reduce the leakage rate after sleeve gastrectomy.

Official Title
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Staple-line Suture Reinforcement: Could it Help Contain the Leak?

Conditions
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Bariatric Surgery Candidate, Obesity, Morbid, Leak, Anastomotic, Bleeding

Intervention / Treatment
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* Procedure: laparoscopic sleeve gastrectomy without suture reinforcement
* Procedure: laparoscopic sleeve gastrectomy with suture reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI>40 kg/m2 BMI>35 kg/m2with at least one associated major comorbidity Exclusion Criteria: secondary obesity due to endocrine and psychological disorders patients under antiaggregant and anticoagulant therapy re-do surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement<br>Laparoscopic sleeve gastrectomy running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely. | Procedure: laparoscopic sleeve gastrectomy with suture reinforcement<br>* The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access. At this point, it is applied running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.<br>|
| Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement<br>Laparoscopic sleeve gastrectomy without staple line reinforcement. | Procedure: laparoscopic sleeve gastrectomy without suture reinforcement<br>* The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the importance of staple line reinforcement | reduction of the leak rate in the suture group | 1 year | 
| the importance of staple line reinforcement | the differences of operative time between two groups | During Surgery |