Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Phase 3

• Conditions: Vomiting, Postoperative
• Interventions: Combination Product: Staple line buttressing; Procedure: Staple line inversion

• Registration Number: NCT03104023
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-07
• Last Update Submitted: 2017-06-25
• Last Update Posted: 2017-06-27
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI >40
• BMI>35 with obesity-related comorbidities

Exclusion Criteria

• Patients undergoing other bariatric techniques than sleeve gastrectomy
• Laparotomic approach

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Staple line buttressing	Staple line buttressing	The gastric section will be performed with preloaded buttress material .
Staple line inversion	Staple line inversion	Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0.

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomits	24 hours after surgery	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.

Trial Locations

Locations (1)

Hospital general Universitario de Elche; 🇪🇸 Elche, Alicante, Spain