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Completed

NCT Number: NCT02931292

A Decade of Sleeve Gastrectomy: 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous history of obesity surgery

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

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.

Primary outcomes

  1. 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

  1. Hemoglobin A1c (HbA1c)

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

    Definitions of glycemic outcomes after sleeve gastrectomy

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Medical Park Gaziantep Hospital

Other

Collaborators

  • Harran University

Registry information

Official study title

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

Acronym: SG

Important dates

Study start
2005
Primary completion
2015
Study completion
2016
First posted
Oct 13, 2016
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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