N/A
Completed N=72
Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity
Source: ClinicalTrials.gov NCT01806506 ↗Enrolled (actual)
72
Serious AEs
4.2%
Results posted
Feb 2019
Primary outcomePrimary: Excess Weight Loss From Baseline — 67.8; 64.2 percentage of EWL
Summary
Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Excess Weight Loss From Baseline |
67.8; 64.2 | — |
| SECONDARY Number of Patients With Complications |
— | — |
| SECONDARY Comorbidities Prevalence Changes |
— | — |
| SECONDARY Change in Weight From Baseline |
— | — |
| SECONDARY Change in BMI From Baseline |
— | — |
| SECONDARY Plasma Total Cholesterol at 12 Months |
— | — |
| SECONDARY Plasma HDL at 12 Months |
— | — |
| SECONDARY Plasma LDL at 12 Months |
— | — |
| SECONDARY Plasma Triglycerides at 12 Months |
— | — |
| SECONDARY Plasma Glucose at 12 Months |
— | — |
| SECONDARY Plasma Insulin at 12 Months |
— | — |
| SECONDARY Plasma C-peptide at 12 Months |
— | — |
| SECONDARY HOMA Index at 12 Months |
— | — |
| SECONDARY HbA1c at 12 Months |
— | — |
| SECONDARY Plasma CRP at 12 Months |
— | — |
| SECONDARY Plasma Uric Acid at 12 Months |
— | — |
| SECONDARY Plasma Ghrelin at 12 Months |
— | — |
| SECONDARY Plasma Leptin at 12 Months |
— | — |
| SECONDARY Plasma Glucagon at 12 Months |
— | — |
| SECONDARY Plasma IGF-1 at 12 Months |
— | — |
| SECONDARY AST Level |
— | — |
| SECONDARY ALT Level |
— | — |
| SECONDARY INR |
— | — |
| SECONDARY Albumin Level |
— | — |
| SECONDARY GGT Level |
— | — |
| SECONDARY ALP Level |
— | — |
| SECONDARY LDH Level |
— | — |
Eligibility Criteria
Inclusion Criteria
- BMI≥40 kg/m2
- BMI≥35 kg/m2 with at least one comorbidity associated with obesity
Exclusion Criteria
- BMI > 60 kg/m2
- poorly controlled significant medical or psychiatric disorders
- active alcohol or substance abuse
- active duodenal/gastric ulcer disease
- difficult to treat gastro-esophageal reflux disease with a large hiatal hernia
- previous major gastrointestinal surgery
- diagnosed or suspected malignancy
Data sourced from ClinicalTrials.gov (NCT01806506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.