Reinforcement Method in Laparoscopic Sleeve Gastrectomy

Overview

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.

Full Title of Study: “Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2014

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.

Interventions

  • Other: observation

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • assessing prevalence of leaks among different reinforcement methods
    • Time Frame: 3 months
    • observation

Participating in This Clinical Trial

Inclusion Criteria

  • body mass index >40 kg/m2 Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fatih Sultan Mehmet Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: M.Timucin Aydin, Attending Surgeon, Department of Surgery – Fatih Sultan Mehmet Training and Research Hospital

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