Reinforcement Method in Laparoscopic Sleeve Gastrectomy

Completed

• Conditions: Laparoscopic Sleeve Gastrectomy
• Interventions: Other: observation

• Registration Number: NCT03051919
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

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.

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 Timeline

• Study Start: 2014-03
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Study First Submitted: 2015-04-01
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Last Update Submitted: 2017-02-18
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• body mass index >40 kg/m2

Exclusion Criteria

• disruption of the resected stomach during extraction from the abdomen.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biological buttressing materaia	observation	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.
no reinforcement	observation	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	observation	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	observation	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.

Primary Outcome Measures

Name	Time	Method
assessing prevalence of leaks among different reinforcement methods	3 months	observation