Clinical trial NCT02931292: A Decade of Sleeve Gastrectomy: Analysis of Short and Long-term Outcome of 562 Patients
Official title: A Decade of Sleeve Gastrectomy as a Single Bariatric/Metabolic Procedure: Analysis of Short and Long-term Outcome of 562 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Obesity
Diabetes
Dyslipidemia
Hypertension
Keywords: sleeve gastrectomy
laparoscopy
bariatric surgery
obesity surgery
metabolic surgery
Lead sponsor: Medical Park Gaziantep Hospital
Sponsor class: OTHER
Collaborators: name: Harran University
First posted: 2016-10-13
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous history of obesity surgery

Primary outcomes:
measure: Percent excess body mass index loss (%EBMIL)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: through study completion, an average of 1 year
measure: change on lipid profile
timeFrame: through study completion, an average of 1 year
measure: percent of complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Bahcesehir University, BAU
name: Mehmet Kaplan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: