Back to results

Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Primary Purpose

Vomiting, Postoperative

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Staple line inversion

Staple line buttressing

About this trial

This is an interventional prevention trial for Vomiting, Postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

BMI >40
BMI>35 with obesity-related comorbidities

Exclusion Criteria:

Patients undergoing other bariatric techniques than sleeve gastrectomy
Laparotomic approach

Sites / Locations

Hospital general Universitario de ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Staple line inversion

Staple line buttressing

Arm Description

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

The gastric section will be performed with preloaded buttress material .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03104023

First Posted

March 24, 2017

Last Updated

June 25, 2017

Sponsor

Hospital General Universitario Elche

1. Study Identification

Unique Protocol Identification Number

NCT03104023

Brief Title

Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (Actual)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vomiting, Postoperative

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Staple line inversion

Arm Type

Active Comparator

Arm Description

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

Arm Title

Staple line buttressing

Arm Type

Experimental

Arm Description

The gastric section will be performed with preloaded buttress material .

Intervention Type

Procedure

Intervention Name(s)

Staple line inversion

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

Staple line buttressing

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative nausea and vomits

Description

Time Frame

24 hours after surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI >40 BMI>35 with obesity-related comorbidities Exclusion Criteria: Patients undergoing other bariatric techniques than sleeve gastrectomy Laparotomic approach

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lorea Zubiaga, MD, PhD

obesidadhospitalgeneralelche@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Diez, MD, PhD

neuroestimulacionobesidad@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaime Ruiz-Tovar

Organizational Affiliation

Hospital general Elche

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital general Universitario de Elche

City

Elche

State/Province

Alicante

ZIP/Postal Code

03202

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaime Ruiz-Tovar, MD, PhD

Phone

0034-630534808

jruiztovar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

We'll reach out to this number within 24 hrs