Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG
Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 27, 2017
March 1, 2017
7 months
March 24, 2017
June 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Staple line inversion
ACTIVE COMPARATORPatients will undergo a staple line inversion with a a running suture of Polypropylene 2/0.
Staple line buttressing
EXPERIMENTALThe gastric section will be performed with preloaded buttress material .
Interventions
A staple line inversion will be performed with a running suture of Polypropylene 2/0
The gastric section will be performed with a stapler with preloaded buttress material
Eligibility Criteria
You may qualify if:
- BMI \>40
- BMI\>35 with obesity-related comorbidities
You may not qualify if:
- Patients undergoing other bariatric techniques than sleeve gastrectomy
- Laparotomic approach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital general Universitario de Elche
Elche, Alicante, 03202, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Ruiz-Tovar
Hospital general Elche
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Bariatric Surgery Unit. Hospital general Elche
Study Record Dates
First Submitted
March 24, 2017
First Posted
April 7, 2017
Study Start
January 1, 2017
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
June 27, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share