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

NCT02931292 | Completed

• 1 other identifier: MK-009-MO-SG1
• Study Type: observational
• Target: 562
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Morbid Obesity; Obesity; Diabetes; Dyslipidemia; Hypertension

Keywords

sleeve gastrectomy; laparoscopy; bariatric surgery; obesity surgery; metabolic surgery

Outcome Measures

Primary Outcomes (1)

• Percent excess body mass index loss (%EBMIL)

  calculated using formula: %EBMIL = \[∆BMI / (initial BMI - 25)\] x 100

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Hemoglobin A1c (HbA1c)

  through study completion, an average of 1 year

• change on lipid profile

  through study completion, an average of 1 year

• percent of complications

  through study completion, an average of 1 year

Study Arms (1)

Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

Interventions

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.

Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• previous history of obesity surgery

Sponsors & Collaborators

• Medical Park Gaziantep Hospital: lead
• Harran University: collaborator

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Diabetes Mellitus; Dyslipidemias; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mehmet Kaplan, M.D.

  Bahcesehir University, BAU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: October 13, 2016
• Study Start: June 1, 2005
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share