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
About this trial
This is an interventional prevention trial for Vomiting, Postoperative
Eligibility Criteria
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
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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