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| Name | Class |
|---|---|
| Rijnstate Hospital | OTHER |
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The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.
The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.
An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.
Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).
Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).
Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage, since only one anastomosis is made (6,8) Only performing one anastomosis leads to less operating time, shorter time of anesthesia, and less usage of staple material. Which possibly makes this a safer and cheaper procedure.
Both techniques, EPGB and OAGB, seem to be adequate alternatives for the RYGB in patients with a BMI of 45 or higher. As of yet, the two techniques haven't been compared one to one. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Pouch gastric bypass (EPGB) | Other | Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. |
|
| One Anastomosis gastric bypass (OAGB) | Other | Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomizing for EPGB procedure | Procedure | Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Weightloss short term | percentage excess weight loss | 1, 3 and 5 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Weightloss long term | percentage excess weight loss | 5-10 years postoperatively |
| Complications short term | bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilian van Hogezand, MD | Contact | +31883206151 | l.van.hogezand@antoniusziekenhuis.nl | |
| Wetenschapsloket St. Antonius Ziekenhuis | Contact | +31883208761 | wetenschapsloket@antoniusziekenhuis.nl |
| Name | Affiliation | Role |
|---|---|---|
| Wouter Derksen, MD PhD | St. Antonius Hospital | Principal Investigator |
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No sharing.
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Single blinded randomized controlled trial
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Patients will be randomized single blinded for one of two study arms/procedures. 3 years post-operative unblinding will be done for participants wishing this.
|
| Randomizing for OAGB procedure | Procedure | Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm. Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB. Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires. |
|
| up to 30 days postoperatively |
| Complications long term | vitamin/electrolyte deficiencies, internal herniation, marginal ulceration | from 30 days until 10 years postoperatively |
| Revision of the bypass | Surgical revision of bypass | until 10 years postoperatively |
| Comorbidities | Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome | until 10 years postoperatively |
| Deficiencies in blood - red blood count | Blood samples: red blood count | until 10 years postoperatively |
| Deficiencies in blood - vitamins | Blood samples vitamins | until 10 years postoperatively |
| Deficiencies in blood - electrolytes | Blood samples: electrolytes | until 10 years postoperatively |
| Reflux/dumping questionnaire | Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome | until 10 years postoperatively |
| Health related quality of life questionnaire | Questionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome | until 10 years postoperatively |
| Peroperative complications | Peroperative complications: bleeding, iatrogenic complications | until 10 years postoperatively |
| Number of patients with peroperative conversion to sleeve | Conversion to sleeve when bypass not feasible | until 10 years postoperatively |