A Decade of Sleeve Gastrectomy: Analysis of Short and Long-term Outcome of 562 Patients (SG)

October 12, 2016 updated by: Mehmet Kaplan, Medical Park Gaziantep Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

From Jun 2005 to Jun 2015, overall 562 consecutive morbidly obese patients admitted to the Hatem Hospital and Medical park Gaziantep Hospital that underwent sleeve gastrectomy for morbid obesity and/or its related co-morbidities were included to the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • previous history of obesity surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sleeve Gastrectomy
Laparoscopic sleeve gastrectomy
Procedure: Laparoscopic sleeve gastrectomy
Special care was given to the complete mobilization of the gastric fundus, with meticulous dissection of the posterior gastric wall from the left pillar. A 36-Fr calibration bougie was used. Resection started 2 to 6 cm from pylorus, and it was conducted upward to 1.5 cm from the angle of His, to avoid the "critical area." A gastric remnant of 60-80 mL volume (measured by administering methylene blue saline solution via nasogastric tube) was obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: through study completion, an average of 1 year
Definitions of glycemic outcomes after sleeve gastrectomy
through study completion, an average of 1 year
change on lipid profile
Time Frame: through study completion, an average of 1 year
Change on lipid profile before and after bariatric surgery was reported according to the Adult Treatment Panel III Guidelines, 2001, of the National Heart, Lung and Blood Institute as follows: no change, improvement in dislipidemia (defined as decrease in number or dose of lipid-lowering agents with equivalent control of dyslipidemia or improved control of lipids on equivalent medication) and remission (defined as normal lipid panel off medication).
through study completion, an average of 1 year
percent of complications
Time Frame: through study completion, an average of 1 year
Complications were evaluated under two headings. Major complications were defined as any complication that resulted in a prolonged hospital stay (beyond 7 days), reintervention, or reoperation. Minor complications were included everything else that is not included under major. They were further categorized as early if observed in 30 days or late if beyond 30 days.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Park Gaziantep Hospital

Collaborators

Harran University

Investigators

  • Principal Investigator: Mehmet Kaplan, M.D., Bahcesehir University, BAU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 9, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK-009-MO-SG1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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