Reinforcement Method in Laparoscopic Sleeve Gastrectomy
February 18, 2017 updated by: M.Timucin Aydin, Fatih Sultan Mehmet Training and Research Hospital
Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigator compared non-reinforced stapling with three staple line reinforcement methods (suturing, absorbable buttressing material and fibrin glue) in laparoscopic sleeve gastrectomy.
The resected stomach specimens were treated in the same manner of reinforcement as used in the surgeries of the corresponding patients and then insufflated until a burst occurred. The burst pressures of the resected stomach specimens and postoperative events of the patients were recorded.
Study Type
Observational
Enrollment (Actual)
118
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
118 patients with body mass index >40 kg/m2 underwent sleeve gastrectomy and were enrolled into four groups
Description
Inclusion Criteria:
- body mass index >40 kg/m2
Exclusion Criteria:
- disruption of the resected stomach during extraction from the abdomen.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessing prevalence of leaks among different reinforcement methods
Time Frame: 3 months
|
observation
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
April 1, 2015
First Submitted That Met QC Criteria
February 9, 2017
First Posted (ACTUAL)
February 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 18, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- FSMTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.