Skip to main content
Clinical Trials/NCT02931292
NCT02931292CompletedNot Applicable

A Decade of Sleeve Gastrectomy as a Single Bariatric/Metabolic Procedure: Analysis of Short and Long-term Outcome of 562 Patients

Medical Park Gaziantep Hospital0 sites562 target enrollmentStarted: June 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
562
Primary Endpoint
Percent excess body mass index loss (%EBMIL)

Study Overview

Brief Summary

Obesity is a chronic disease and its treatment requires close follow-up to accurately assess the efficacy and durability of any treatment strategy. It is widely accepted that bariatric surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes, and nutritional deficiencies.

The study objective was to ascertain efficacy of weight loss and complication rates in 562 consecutive cases of laparoscopic sleeve gastrectomy (LSG) in a single surgeon practice.

Detailed Description

Obesity is a major healthcare problem reaching epidemic proportion and affecting people of all age (1). The only treatment that proven effective option for a significant substantial long-term weight loss and that cures or durably improves comorbidities is still bariatric surgery (2, 3). Because obesity is a chronic disease, it is widely accepted that to accurately assess the efficacy and durability of any type of bariatric surgery requires lifetime follow-up to assess for weight loss, co-morbidity changes, and nutritional deficiencies.

Despite initially performed as a first part of the staged procedures, the laparoscopic sleeve gastrectomy (LSG) has since introduced as a stand-alone bariatric operation associated with good, short and mid-term weight loss and satisfactory complication rates when conducted in experienced hands. Although simplicity and the overall efficacy of the procedure supported by meta-analysis and systematic review (4, 5), there are still limited long-term outcome data (6). Due to publication bias or multiple controversies regarding the technique of LSG, some of the available data may have underreported which has also been resulted in questioning the long-term weight loss efficacy of the procedure.

Although addressed by a recent consensus document,12 there are multiple controversies regarding the technique of LSG, and this may in part be what has led to the variable published results.

The study objective was to assess the long-term (≥ 5 years) as well as short (1 to ≤ 3 years) and mid-term (> 3 to < 5 years) results in regard to the BMI change, resolution of co-morbidities and complications in 562 consecutive morbidly obese patients undergoing LSG as a primary procedure.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • underwent LSG for morbid obesity and related morbidities as a primary procedure

Exclusion Criteria

  • previous history of obesity surgery

Outcomes

Primary Outcomes

Percent excess body mass index loss (%EBMIL)

Time Frame: through study completion, an average of 1 year

calculated using formula: %EBMIL = \[∆BMI / (initial BMI - 25)\] x 100

Secondary Outcomes

  • change on lipid profile(through study completion, an average of 1 year)
  • Hemoglobin A1c (HbA1c)(through study completion, an average of 1 year)
  • percent of complications(through study completion, an average of 1 year)

Investigators

Sponsor
Medical Park Gaziantep Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Kaplan

Principal Investigator

Medical Park Gaziantep Hospital

Similar Trials

A Decade of Sleeve Gastrectomy: Analysis... | Clinical Trial