Extending and Banding the Roux-en-Y Gastric Bypass (UPGRADE)
Primary Purpose
Morbid Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Standard RYGB
Extended Pouch RYGB
Banded extended pouch RYGB
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- All patients who are eligible for a primary RYGB
Exclusion Criteria:
- Bariatric surgery in medical history
- Patients with a language barrier which may affect the compliance with medical advice
- Patients with a disease not related to morbid obesity, such as Cushing or drug related.
- Chronic bowel disease for example Crohn's disease or colitis Colitis.
- Renal impairment (MDRD <30)
- Hepatic dysfunction (liver function twice the normal values)
- Pregnancy during follow-up
- Patients with treatment-resistant reflux symptoms.
Sites / Locations
- Rijnstate HospitalRecruiting
- St. Antonius Ziekenhuis
- NOK West
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Standard RYGB
Extended Pouch RYGB
Banded Extended RYGB
Arm Description
127 patients undergo a standard Roux-en-Y gastric bypass
127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.
127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.
Outcomes
Primary Outcome Measures
Percentage Total Body Weight Loss (%TBWL)
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
Secondary Outcome Measures
Percentage Excess Weight Loss (%EWL)
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
BODY-Q: Quality of life after bariatric surgery
BODY-Q: Patient reporterd outcome measurement, The questionnaire measures three domains; health related quality of life, appearance and experience of healthcare. Each domain is composed of independently functioning scales. Each scale contains different statements, which can be scored on four levels ranging from totally disagree to totally agree or from never to always. The sum of levels ranging from 1 to 4 is the raw score of the different scales. This score can be converted into a Rasch Transformed score ranging from 0, worst score, to 100, best score.
BAROS: Quality of life after bariatric surgery
BAROS; evaluates the results of obesity treatments by analyzing 3 domains: weight loss, changes in co-morbidities, and quality of life. Up to 3 points are allowed for each, and points are deducted for complications and reoperations. The final score classifies the results in 5 outcome groups, providing an objective definition of success or failure.
SF-36: Quality of life after bariatric surgery
SF-36; consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Gastroesophageal reflux disease
GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Change in comorbidities in patients pre- and postoperative
Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05357807
Brief Title
Extending and Banding the Roux-en-Y Gastric Bypass
Acronym
UPGRADE
Official Title
Extending and Banding the Roux-en-Y Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
Detailed Description
The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.
A prospective randomize controlled trial.
Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI > 40 kg/m2 without any comorbidities.
Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
381 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard RYGB
Arm Type
Active Comparator
Arm Description
127 patients undergo a standard Roux-en-Y gastric bypass
Arm Title
Extended Pouch RYGB
Arm Type
Experimental
Arm Description
127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.
Arm Title
Banded Extended RYGB
Arm Type
Experimental
Arm Description
127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.
Intervention Type
Procedure
Intervention Name(s)
Standard RYGB
Other Intervention Name(s)
S-RYGB
Intervention Description
Roux-en-Y Gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Extended Pouch RYGB
Other Intervention Name(s)
EP-RYGB
Intervention Description
Roux-en-Y gastric bypass with an extended pouch
Intervention Type
Procedure
Intervention Name(s)
Banded extended pouch RYGB
Other Intervention Name(s)
BEP-RYGB
Intervention Description
Roux-en-Y gastric bypass with a banded extended pouch
Primary Outcome Measure Information:
Title
Percentage Total Body Weight Loss (%TBWL)
Description
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage Excess Weight Loss (%EWL)
Description
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
Time Frame
3 years
Title
BODY-Q: Quality of life after bariatric surgery
Description
BODY-Q: Patient reporterd outcome measurement, The questionnaire measures three domains; health related quality of life, appearance and experience of healthcare. Each domain is composed of independently functioning scales. Each scale contains different statements, which can be scored on four levels ranging from totally disagree to totally agree or from never to always. The sum of levels ranging from 1 to 4 is the raw score of the different scales. This score can be converted into a Rasch Transformed score ranging from 0, worst score, to 100, best score.
Time Frame
3 years
Title
BAROS: Quality of life after bariatric surgery
Description
BAROS; evaluates the results of obesity treatments by analyzing 3 domains: weight loss, changes in co-morbidities, and quality of life. Up to 3 points are allowed for each, and points are deducted for complications and reoperations. The final score classifies the results in 5 outcome groups, providing an objective definition of success or failure.
Time Frame
3 years
Title
SF-36: Quality of life after bariatric surgery
Description
SF-36; consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame
3 years
Title
Gastroesophageal reflux disease
Description
GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Time Frame
3 years
Title
Change in comorbidities in patients pre- and postoperative
Description
Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who are eligible for a primary RYGB
Exclusion Criteria:
Bariatric surgery in medical history
Patients with a language barrier which may affect the compliance with medical advice
Patients with a disease not related to morbid obesity, such as Cushing or drug related.
Chronic bowel disease for example Crohn's disease or colitis Colitis.
Renal impairment (MDRD <30)
Hepatic dysfunction (liver function twice the normal values)
Pregnancy during follow-up
Patients with treatment-resistant reflux symptoms.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rijnstate Hazebroek
Phone
+31880055970
Email
info@vitalys.nl
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazebroek
Phone
0880055970
Email
info@vitalys.nl
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derksen
Facility Name
NOK West
City
Den Haag
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liem
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Extending and Banding the Roux-en-Y Gastric Bypass
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