The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: 1. %TBWL 5 years after surgery. Secondary

Objectives: 2. Percentage Excess Weight Loss (%EWL) 5 years after surgery. 3. Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints). 4. Improvement of quality of life: SF-36 and OBESI-Q questionnaires. 5. Incidence and severity of dumping syndrome. 6. Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire. 7. Incidence and complications due to silicone band. Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery: Expected advantages of bOLGB versus OLGB: 1. Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight. 2. Long term decrease of weight regain. 3. Decrease of incidence of dumping. Possible disadvantages of bOLGB versus OLGB: 1. Band-related complications such as erosion, infection, stenosis, or pouch dilatation. 2. Functional gastro-intestinal complains such as dysphagia and reflux.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients meet IFSO criteria for Bariatric Surgery

• Age 18 and above

Locations
Other Locations
Netherlands
Ziekenhuisgroep Twente
RECRUITING
Almelo
Contact Information
Primary
Marc J van Det, MD PhD
m.vdet@zgt.nl
+31887087878
Backup
Maureen Tissink, MD
m.tissink@zgt.nl
+31887087878
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 210
Treatments
Experimental: Banded Mini Gastric Bypass
Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Gastric Ring (Bariatric Solutions GmbH, Stein am Rhein Switzerland)
Active_comparator: non-Banded Mini Gastric Bypass
Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB)
Sponsors
Leads: Marc van Det
Collaborators: Ziekenhuisgroep Twente

This content was sourced from clinicaltrials.gov