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| Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity |
| Current status of trial | Active, not recruiting |
| Sponsors and collaborators | Göteborg University |
| Information provided by | Göteborg University |
| ClinicalTrials.gov identifier | NCT00327912 |
| Purpose | The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2). |
| Condition(s) | Obesity Diabetes Hypertension |
| Intervention(s) | Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch Procedure: Laparoscopic Roux-en-Y Gastric Bypass |
| Phase | Phase IV |
| Study type and design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Official title | Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial |
| Further study details | Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting. Superobesity (BMI > 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity. This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years. |
| Primary outcome | BMI 5 y Yes Metabolic normalization 5y Yes Gastro-intestinal side effects 5y Yes |
| Secondary outcome | Health economics 5y Yes Vitamin/mineral deficiencies 5y Yes Body composition 5y No Quality of life 5y Yes Eating pattern 5y Yes |
| Study start | April 2006 |
| Minimum age | 20 Years |
| Maximum age | 50 Years |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - BMI 50-60 kg/m2 Exclusion Criteria: - Prior obesity operation - Prior major abdominal surgical procedure - Severe disabling cardiopulmonary disease - Malignancy - Oral steroid treatment - Condition associated with poor compliance |
| Study chairs or principal investigators | Hans H Lönroth, MD, PhD, Study Chair, Sahlgrenska University Hospital, Sweden Tom Mala, MD, PhD, Study Chair, Aker University Hospital, Oslo, Norway Jon Kristinsson, MD, PhD, Study Chair, Aker University Hospital, Oslo, Norway |
| Locations | Norway Dept of Surgery, Aker University Hospital Oslo Sweden Dept of Surgery, Sahlgrenska University Hospital Gothenburg 41345 |
| Study ID numbers | SU688-02 |
| Last updated | December 20, 2010 |
| Record first received | May 18, 2006 |
| ClinicalTrials.gov identifier | NCT00327912 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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