Outcomes of Laparoscopic Sleeve Gastrectomy

Long Term Outcomes of Laparoscopic Sleeve Gastrectomy: First Five Years' Results of a Single Center From a Developing Country

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study group; Patients who undergo laparoscopic sleeve gastrectomy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight loss after surgery	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remision of comorbid diseases	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?"	5 years

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 25, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: BakirkoySKGeneralSurgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No