Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Sponsor

Hospital General Universitario Elche (Other)

Overall Status

Unknown status

CT.gov ID

NCT03104023

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vomiting, Postoperative	Procedure: Staple line inversion Combination Product: Staple line buttressing	Phase 3

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Staple line inversion

Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0.

Procedure: Staple line inversion

A staple line inversion will be performed with a running suture of Polypropylene 2/0

Experimental: Staple line buttressing

The gastric section will be performed with preloaded buttress material .

Combination Product: Staple line buttressing

The gastric section will be performed with a stapler with preloaded buttress material

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI >40
BMI>35 with obesity-related comorbidities

Exclusion Criteria:

Patients undergoing other bariatric techniques than sleeve gastrectomy
Laparotomic approach

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital general Universitario de Elche	Elche	Alicante	Spain	03202

Sponsors and Collaborators

Hospital General Universitario Elche

Investigators

Principal Investigator: Jaime Ruiz-Tovar, Hospital general Elche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jaime Ruiz-Tovar, MD, PhD, Head of Bariatric Surgery Unit. Hospital general Elche, Hospital General Universitario Elche

ClinicalTrials.gov Identifier:

NCT03104023

Other Study ID Numbers:

HGUE 2016-33

First Posted:

Apr 7, 2017

Last Update Posted:

Jun 27, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vomiting

Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Jun 27, 2017