Outcomes of Laparoscopic Sleeve Gastrectomy

Overview

The aim of this study is to assess 5 year long-term outcomes of laparoscopic sleeve gastrectomy emphasizing weight loss and modification of comorbidities such as type 2 diabetes mellitus, hypertension and gastroesophageal reflux disease from a developing country, Turkey. Prospectively-collected patient data will retrospectively reviewed. To measure the efficacy of the procedure, we will calculate the excess weight loss percentage (EWL %). Effective weight loss after LSG will accepted as more than 50%. The changes in the status of the type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease will be observed.

Full Title of Study: “Long Term Outcomes of Laparoscopic Sleeve Gastrectomy: First Five Years’ Results of a Single Center From a Developing Country”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2013

Interventions

  • Procedure: Laparoscopic sleeve gastrectomy
    • Each procedure will be completed with laparoscopy with five trocars. A 36F bougie will used to calibrate the volume of the remnant stomach. Linear gastrectomy will begin 2 cm proximal of the pylor and will continue until the gastroesophageal junction. According to the intraoperative decision and experience of the surgeon, endoscopic clips would be used to ensure hemostasis of the stapler line.

Arms, Groups and Cohorts

  • Experimental: Study group
    • Patients who undergo laparoscopic sleeve gastrectomy

Clinical Trial Outcome Measures

Primary Measures

  • Weight loss
    • Time Frame: 5 years
    • Weight loss after surgery

Secondary Measures

  • Remision of comorbid diseases
    • Time Frame: 5 years
    • The pharmacological treatment status of comorbidities related to obesity of type 2 diabetes (T2DM) and hypertension and gastroesophageal reflux will be observed with questions about “did it stop after surgery (improvement), did the dose or number of medications used reduce (resolution), or were there no changes?”

Participating in This Clinical Trial

Inclusion Criteria

Inclusion criteria were, patients between 18 to 65 years old, initial body mass index (BMI) 40 kg/m2 or BMI of 35 kg/m2 in the presence of additional comorbidity and failure of conservative treatment for 2 years. Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hakan Seyit, Principal Investigator – Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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