Reinforcement Method in Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks

Conditions
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Laparoscopic Sleeve Gastrectomy

Intervention / Treatment
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* Other: observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index >40 kg/m2 Exclusion Criteria: disruption of the resected stomach during extraction from the abdomen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no reinforcement<br>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. | Other: observation<br> <br> |
| fibrin glue<br>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. | Other: observation<br> <br> |
| suture reinforcement<br>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. | Other: observation<br> <br> |
| biological buttressing materaia<br>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. | Other: observation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing prevalence of leaks among different reinforcement methods | observation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic sleeve gastrectomy, reinforcement, leak