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

NCT ID: NCT02931292

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 562 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Morbid Obesity; Obesity; Diabetes; Dyslipidemia; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• previous history of obesity surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harran University

OTHER

Sponsor Role: collaborator

Medical Park Gaziantep Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Kaplan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Kaplan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bahcesehir University, BAU

Other Identifiers

MK-009-MO-SG1

Identifier Type: -

Identifier Source: org_study_id