Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Postoperative nausea and vomits
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI>35 with obesity-related comorbidities
Exclusion Criteria
- •Patients undergoing other bariatric techniques than sleeve gastrectomy
- •Laparotomic approach
Outcomes
Primary Outcomes
Postoperative nausea and vomits
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jaime Ruiz-Tovar, MD, PhD
Head of Bariatric Surgery Unit. Hospital general Elche
Hospital General Universitario Elche