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| Sponsored by: |
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 | Intervention | Phase |
|---|---|---|
|
Obesity Diabetes Hypertension |
Procedure: Laparoscopic Roux-en-Y Gastric Bypass Procedure: Laparoscopic Biliopancreatic Diversion with Duodenal Switch |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | April 2012 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Torsten Olbers, MD, PhD | +46-31-3421000 ext 28347 | torsten.olbers@vgregion.se |
| Contact: My Svensson, RN | +46-31-3421000 ext 28404 | my.svensson@vgregion.se |
| Norway | |
| Dept of Surgery, Aker University Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Torgeir Sovik, MD +47-22 89 40 00 Torgeir.Sovik@akersykehus.no | |
| Contact: Erlend T Aasheim, MD +47-22 89 40 00 e.t.aasheim@medisin.uio.no | |
| Principal Investigator: Jon Kristinsson, MD, PhD | |
| Sub-Investigator: Tom Mala, MD, PhD | |
| Sweden | |
| Dept of Surgery, Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, 41345 | |
| Contact: My Svensson, RN +46-31- 3421000 ext 28404 my.svensson@vgregion.se | |
| Contact: Sofia Björkman, RD +46-31-3421000 sofia.bjorkman@vgregion.se | |
| Principal Investigator: Torsten Olbers, MD, PhD | |
| Sub-Investigator: Hans H Lönroth, MD, PhD | |
| Study Chair: | Hans H Lönroth, MD, PhD | Sahlgrenska University Hospital, Sweden |
| Study Chair: | Tom Mala, MD, PhD | Aker University Hospital, Oslo, Norway |
| Study Chair: | Jon Kristinsson, MD, PhD | Aker University Hospital, Oslo, Norway |
More Information
| Study ID Numbers: | SU688-02 |
| Study First Received: | May 18, 2006 |
| Last Updated: | October 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00327912 History of Changes |
| Health Authority: | Sweden: The National Board of Health and Welfare; Norway: Norwegian Board of Health |
|
Obesity Surgery Gastric bypass Biliopancreatic diversion with Duodenal switch Laparoscopy |
|
Body Weight Signs and Symptoms Obesity Vascular Diseases Diabetes Mellitus |
Nutrition Disorders Overweight Overnutrition Hypertension |
|
Body Weight Signs and Symptoms Obesity Vascular Diseases Nutrition Disorders |
Overweight Overnutrition Cardiovascular Diseases Hypertension |
