Clinical Trials Directory

Trials / Completed

CompletedNCT02931292

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
562 (actual)
Sponsor
Medical Park Gaziantep Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic sleeve gastrectomySpecial 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.

Timeline

Start date
2005-06-01
Primary completion
2015-06-01
Completion
2016-06-01
First posted
2016-10-13
Last updated
2016-10-13

Source: ClinicalTrials.gov record NCT02931292. Inclusion in this directory is not an endorsement.