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NCT03104023 Clinical Trial

Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Vomiting, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03104023
Other study ID # HGUE 2016-33
Secondary ID
Status Recruiting
Phase Phase 3
First received March 24, 2017
Last updated June 25, 2017
Start date January 2017
Est. completion date August 2017

Study information
Verified date March 2017
Source Hospital General Universitario Elche
Contact Lorea Zubiaga, MD, PhD
Email obesidadhospitalgeneralelche@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- BMI >40

- BMI>35 with obesity-related comorbidities

Exclusion Criteria:

- Patients undergoing other bariatric techniques than sleeve gastrectomy

- Laparotomic approach

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Staple line inversion
A staple line inversion will be performed with a running suture of Polypropylene 2/0
Combination Product:
• Staple line buttressing
The gastric section will be performed with a stapler with preloaded buttress material

Locations
Country Name City State
Spain Hospital general Universitario de Elche Elche Alicante

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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