Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lund University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.
Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.
Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal gastrojejunal bypass | Experimental | RYGB with 200 cm BP limb and 150 cm common limb |
|
| RYGB | Active Comparator | RYGB with 60 cm BP limb and 150 cm alimentary limb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distal gastrojejunal bypass | Procedure | RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight reduction | Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc. | 2 years from end of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient assessed quality of life | We employ SF-36, Op-9, GSRS, TFEQ scales | 2 years from end of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term complications | Time to discharge, leaks, bleeding | 0-30 days postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Hedenbro, MD,PhD | Contact | +46705132572 | jan.hedenbro@aleris.se | |
| Hjortur G Gislason, MD,PhD | Contact | +4748891375 | hjortur.gislason@aleris.no |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aleris Obesity | Recruiting | Lund | Sweden |
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RYGB | Procedure | RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |