Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Study Overview
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Brief Summary
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Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material Postoperative nausea and vomits during the first 24 hours will be investigated.

Detailed Description
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Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA). Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.

Official Title
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Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)

Conditions
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Vomiting, Postoperative

Intervention / Treatment
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* Procedure: Staple line inversion
* Combination Product: Staple line buttressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >40 BMI>35 with obesity-related comorbidities Exclusion Criteria: Patients undergoing other bariatric techniques than sleeve gastrectomy Laparotomic approach
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staple line inversion<br>Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0. | Procedure: Staple line inversion<br>* A staple line inversion will be performed with a running suture of Polypropylene 2/0<br>|
| Experimental: Staple line buttressing<br>The gastric section will be performed with preloaded buttress material . | Combination Product: Staple line buttressing<br>* The gastric section will be performed with a stapler with preloaded buttress material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomits | Postoperative nausea and vomits will be measured using the postoperative nausea and vomiting intensity scale, described by Wengritzky et al (Br J Anaesth 2010;104:158-166). In this scale, the number of vomits are quantified, the frequence of nausea and if it is constant or varying are determined, and the duration of the feeling of nausea is established. | 24 hours after surgery |