Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06204939
Other study ID # 1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 1, 2029

Study information

Verified date January 2024
Source St. Antonius Hospital
Contact Lilian van Hogezand, MD
Phone +31883206151
Email l.van.hogezand@antoniusziekenhuis.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date December 1, 2029
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria: - BMI=45 - Bariatric guidelines Fried - Age 18-65 - Dedication to guided preoperative program - Intention to follow full postoperative program Exclusion criteria: - Secondary bariatric procedure - Medical(-related) cause for morbid obesity or fast weight gain (e.g. Cushing or medication related) - Inflammatory Bowel Disease (M. Crohn or Colitis Ulcerosa) - Renal function disorder (MDRD <30) or liver disease - Anticipated absence of yearly medical follow up - Does not speak Dutch language - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Randomizing for EPGB 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.
Randomizing for OAGB 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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
L. van Hogezand Rijnstate Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Weightloss short term percentage excess weight loss 1, 3 and 5 years postoperatively
Secondary Weightloss long term percentage excess weight loss 5-10 years postoperatively
Secondary Complications short term bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality up to 30 days postoperatively
Secondary Complications long term vitamin/electrolyte deficiencies, internal herniation, marginal ulceration from 30 days until 10 years postoperatively
Secondary Revision of the bypass Surgical revision of bypass until 10 years postoperatively
Secondary Comorbidities Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome until 10 years postoperatively
Secondary Deficiencies in blood - red blood count Blood samples: red blood count until 10 years postoperatively
Secondary Deficiencies in blood - vitamins Blood samples vitamins until 10 years postoperatively
Secondary Deficiencies in blood - electrolytes Blood samples: electrolytes until 10 years postoperatively
Secondary Reflux/dumping questionnaire Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome until 10 years postoperatively
Secondary 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
Secondary Peroperative complications Peroperative complications: bleeding, iatrogenic complications until 10 years postoperatively
Secondary Number of patients with peroperative conversion to sleeve Conversion to sleeve when bypass not feasible until 10 years postoperatively
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Withdrawn NCT05845359 - Intraoperative Methadone for Postoperative Pain Control Phase 4
Not yet recruiting NCT04343040 - Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients N/A
Withdrawn NCT03095404 - Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery Early Phase 1
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT04883268 - Focusing on Body Functionality After Bariatric Surgery N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02300168 - Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery N/A
Unknown status NCT01264120 - The Impact of a Bariatric Rehabilitation Service on Patient Outcomes N/A
Recruiting NCT03972319 - Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study Early Phase 1
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Completed NCT04219852 - Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A