Reinforcement Method in Laparoscopic Sleeve Gastrectomy
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ClinicalTrials.gov Identifier: NCT03051919 |
Recruitment Status :
Completed
First Posted : February 14, 2017
Last Update Posted : February 23, 2017
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Condition or disease | Intervention/treatment |
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Laparoscopic Sleeve Gastrectomy | Other: observation |
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 |
Actual Enrollment : | 118 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | October 2014 |
Group/Cohort | Intervention/treatment |
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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.
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Other: observation |
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.
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Other: observation |
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.
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Other: observation |
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.
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Other: observation |
- assessing prevalence of leaks among different reinforcement methods [ Time Frame: 3 months ]observation
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- body mass index >40 kg/m2
Exclusion Criteria:
- disruption of the resected stomach during extraction from the abdomen.
Responsible Party: | M.Timucin Aydin, Attending Surgeon, Department of Surgery, Fatih Sultan Mehmet Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT03051919 |
Other Study ID Numbers: |
FSMTRH |
First Posted: | February 14, 2017 Key Record Dates |
Last Update Posted: | February 23, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Laparoscopic sleeve gastrectomy reinforcement leak |