N/A
N=293
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01754194 ↗Enrolled (actual)
293
Serious AEs
—
Results posted
Jul 2017
Primary outcome: Primary: Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) — 3; 3 Score*months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gastric Sleeve Resection (Procedure); Roux-en-Y Gastric Bypass (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) |
3; 3 | — |
| PRIMARY Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II) |
13; 13 | — |
| PRIMARY Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) |
45; 47 | — |
| SECONDARY Excess Weight Loss (EWL) |
58; 58 | — |
| SECONDARY Health Resource Utilization - Durantion of Sugery |
83.2; 135.9 | — |
| SECONDARY Health Resource Utilization - Recovery Time From Surgery |
7.7; 7.6 | — |
| SECONDARY Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization |
50.9; 51.6 | — |
| SECONDARY Surgical Complications |
7; 6; 1; 6; 2; 4 | — |
Summary
Study objectives:
1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery
2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.
Eligibility Criteria
Inclusion Criteria
- All patients aged from 18 to 65 years of age, inclusive
- BMI > 40 or BMI > 35 with co-morbidities
- Eligible for weight-loss surgery
- Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
- Insurance approval status: approved
- Written informed consent
Exclusion Criteria
- BMI > 55
- Planned two-stage procedures
- Prior bariatric procedures (including gastric banding)
- Serious mental or physical co-morbidities at the discretion of the Investigator
- Insurance approval status: rejected
Data sourced from ClinicalTrials.gov (NCT01754194). 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.