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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
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
March 24, 2017
Last Updated
June 25, 2017
Sponsor
Hospital General Universitario Elche
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Email
obesidadhospitalgeneralelche@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Diez, MD, PhD
Email
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
Email
jruiztovar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

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