Reinforcement Method in Laparoscopic Sleeve Gastrectomy
Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks
1 other identifier
observational
118
0 countries
N/A
Brief Summary
Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement methods are used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2014
Shorter than P25 for all trials
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
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedFebruary 23, 2017
February 1, 2017
6 months
April 1, 2015
February 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assessing prevalence of leaks among different reinforcement methods
observation
3 months
Study Arms (4)
no reinforcement
Group I: 25 patients; no reinforcement (NoR) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
fibrin glue
Group II: 26 patients; fibrin glue (FG) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
suture reinforcement
Group III: 44 patients; suture reinforcement with 2-0 polypropylene suture (S) Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
biological buttressing materaia
Group IV: 14 patients; biological buttressing material Observation : Patients would be followed up for any signs of leaks. If any, treatment would be offered appropriataly but the results of treatment are not affiliated as a part in the study.
Interventions
Eligibility Criteria
118 patients with body mass index \>40 kg/m2 underwent sleeve gastrectomy and were enrolled into four groups
You may qualify if:
- body mass index \>40 kg/m2
You may not qualify if:
- disruption of the resected stomach during extraction from the abdomen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
resected stomachs
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Surgeon, Department of Surgery
Study Record Dates
First Submitted
April 1, 2015
First Posted
February 14, 2017
Study Start
March 1, 2014
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
February 23, 2017
Record last verified: 2017-02