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Clinical Trials/NCT03104023
NCT03104023UnknownPhase 3

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

Hospital General Universitario Elche2 sites in 1 country100 target enrollmentStarted: January 1, 2017Last updated:
Conditions

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

Sponsor
Hospital General Universitario Elche
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaime Ruiz-Tovar, MD, PhD

Head of Bariatric Surgery Unit. Hospital general Elche

Hospital General Universitario Elche

Study Sites (2)

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