Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Hospital of Vestfold | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main study objective:
To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).
The main study hypothesis:
Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.
Technical data will later be published in detail
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long-limb bypass | Active Comparator | Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb) |
|
| Distal gastric bypass | Active Comparator | Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long-limb gastric bypass | Procedure | Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome: weight loss | physical examination | 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome: Quality of life | questionnaire | 2 years postoperative |
| Adverse events | medical history, journals | 2 years postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tom Mala MD, PhD Rune Sandbu, MD, PhD | Aker University Hospital / The Hospital of Vestfold | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep. | Oslo | 0514 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41553109 | Derived | Salte OB, Hagen RE, Svanevik M, Fagerland MW, Risstad H, Hjelmesaeth J, Kristinsson JA, Sandbu R, Mala T. Effect of standard versus long alimentary limb distal Roux-en-Y gastric bypass on weight loss and nutritional outcomes at 10 years in patients with BMI 50-60 kg/m2-a secondary analysis of a randomized clinical trial. Br J Surg. 2025 Dec 24;113(1):znaf285. doi: 10.1093/bjs/znaf285. | |
| 34791048 |
| Label | URL |
|---|---|
| hospital site | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| distal gastric bypass | Procedure | Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb) |
|
| Number of patients with vitamin deficiencies | Blood samples | 2 years postoperative |
| Number of patients with mineral deficiencies | Blood samples | 2 years postoperative |
| Number of participants with malnutrition | Blood samples | 2 years postoperative |
| Weight loss 5 year | physical examination | 5 year postoperative |
| Health related Quality of life | questionnaire | 5 years postoperative |
| Number of patients with malnutrition | Blood samples | 5 years postoperative |
| Number of patients with mineral deficiencies | Blood samples | 5 years postoperative |
| Number of patients with vitamin deficiencies | Blood samples | 5 years postoperative |
| Adverse events | Medical history, journals | 5 years |
| Weight loss 10 years | Weight measure | 10 years postoperative |
| Adverse events | Medical history, journals | 10 years postoperative |
| Number of patients with malnutrition | Blood samples | 10 years postoperative |
| Number of patients with mineral deficiencies | Blood samples | 10 years postoperative |
| Number of patients with vitamin deficiencies | Blood samples | 10 years postoperative |
| Health related Quality of life | questionnaire | 10 years postoperative |
| Derived |
| Salte OBK, Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Johnson LK, Fagerland MW, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Standard versus distal Roux-en-Y gastric bypass in patients with BMI 50-60 kg/m2: 5-year outcomes of a double-blind, randomized clinical trial. BJS Open. 2021 Nov 9;5(6):zrab105. doi: 10.1093/bjsopen/zrab105. |
| 31065919 | Derived | Svanevik M, Risstad H, Hofso D, Blom-Hogestol IK, Kristinsson JA, Sandbu R, Smastuen MC, Thorsby PM, Mala T, Hjelmesaeth J. Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial. Obes Surg. 2019 Sep;29(9):2886-2895. doi: 10.1007/s11695-019-03909-1. |
| 28865057 | Derived | Svanevik M, Risstad H, Karlsen TI, Kristinsson JA, Smastuen MC, Kolotkin RL, Sovik TT, Sandbu R, Mala T, Hjelmesaeth J. Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial. Obes Surg. 2018 Mar;28(3):606-614. doi: 10.1007/s11695-017-2891-3. |
| 27626242 | Derived | Risstad H, Svanevik M, Kristinsson JA, Hjelmesaeth J, Aasheim ET, Hofso D, Sovik TT, Karlsen TI, Fagerland MW, Sandbu R, Mala T. Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1146-1155. doi: 10.1001/jamasurg.2016.2798. |
| 25761943 | Derived | Svanevik M, Risstad H, Hofso D, Schou CF, Solheim B, Sovik TT, Kristinsson J, Hjelmesaeth J, Mala T, Sandbu R. Perioperative Outcomes of Proximal and Distal Gastric Bypass in Patients with BMI Ranged 50-60 kg/m(2)--A Double-Blind, Randomized Controlled Trial. Obes Surg. 2015 Oct;25(10):1788-95. doi: 10.1007/s11695-015-1621-y. |
| hospital site | View source |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |