Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Helse Sor-Ost | OTHER_GOV |
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Laparoscopic Biliopancreatic diversion with Duodenal switch |
|
| 2 | Active Comparator | Laparoscopic Roux-en-Y Gastric Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Biliopancreatic diversion with Duodenal switch | Procedure |
| ||
| Laparoscopic Roux-en-Y Gastric Bypass |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | 5 y | |
| Metabolic normalization | 5y | |
| Gastro-intestinal side effects | 5y |
| Measure | Description | Time Frame |
|---|---|---|
| Health economics | 5y | |
| Vitamin/mineral deficiencies | 5y | |
| Body composition |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hans H Lönroth, MD, PhD | Sahlgrenska University Hospital | Study Chair |
| Tom Mala, MD, PhD | Aker University Hospital, Oslo, Norway | Study Chair |
| Jon Kristinsson, MD, PhD | Aker University Hospital, Oslo, Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Surgery, Aker University Hospital | Oslo | Oslo | Norway | |||
| Dept of Surgery, Sahlgrenska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38829616 | Derived | Salte OBK, Olbers T, Risstad H, Fagerland MW, Sovik TT, Blom-Hogestol IK, Kristinsson JA, Engstrom M, Mala T. Ten-Year Outcomes Following Roux-en-Y Gastric Bypass vs Duodenal Switch for High Body Mass Index: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414340. doi: 10.1001/jamanetworkopen.2024.14340. | |
| 25650964 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| 5y |
| Quality of life | 5y |
| Eating pattern | 5y |
| Gothenburg |
| Gothenburg |
| 41345 |
| Sweden |
| Risstad H, Sovik TT, Engstrom M, Aasheim ET, Fagerland MW, Olsen MF, Kristinsson JA, le Roux CW, Bohmer T, Birkeland KI, Mala T, Olbers T. Five-year outcomes after laparoscopic gastric bypass and laparoscopic duodenal switch in patients with body mass index of 50 to 60: a randomized clinical trial. JAMA Surg. 2015 Apr;150(4):352-61. doi: 10.1001/jamasurg.2014.3579. |
| 21893621 | Derived | Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005. |
| 20035530 | Derived | Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, Schou CF, Lonroth H, Mala T, Olbers T. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg. 2010 Feb;97(2):160-6. doi: 10.1002/bjs.6802. |
| 19439456 | Derived | Aasheim ET, Bjorkman S, Sovik TT, Engstrom M, Hanvold SE, Mala T, Olbers T, Bohmer T. Vitamin status after bariatric surgery: a randomized study of gastric bypass and duodenal switch. Am J Clin Nutr. 2009 Jul;90(1):15-22. doi: 10.3945/ajcn.2009.27583. Epub 2009 May 13. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided