Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204939
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-08
Brief Title:
Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI45
Sponsor:
L van Hogezand
Organization:
St Antonius Hospital
Study Overview
Official Title:
Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPANT
Brief Summary:
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
Detailed Description:
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 sizepouch in the RYGB possibly leading to more weightloss 12
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 4567
Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage since only one anastomosis is made 68 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 havent 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
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 sizepouch in the RYGB possibly leading to more weightloss 12
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 4567
Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage since only one anastomosis is made 68 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 havent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None