Extending and Banding the Roux-en-Y Gastric Bypass (UPGRADE)

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.

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Standard RYGB; Procedure: Extended Pouch RYGB; Procedure: Banded extended pouch RYGB

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.

• Study Type: Interventional
• Enrollment (Anticipated): 381
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rijnstate Hazebroek; Phone Number: +31880055970; Email: info@vitalys.nl

Study Locations

• Netherlands
  • Den Haag, Netherlands
    • Not yet recruiting
    • NOK West
    • Contact: Liem
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Recruiting
      • Rijnstate Hospital
      • Contact: Hazebroek; Phone Number: 0880055970; Email: info@vitalys.nl
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • Not yet recruiting
      • St. Antonius Ziekenhuis
      • Contact: Derksen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard RYGB; 127 patients undergo a standard Roux-en-Y gastric bypass	Procedure: Standard RYGB; Roux-en-Y Gastric bypass; Other Names: S-RYGB
Experimental: Extended Pouch RYGB; 127 patients undergo a Roux-en-Y gastric bypass with an extended pouch.	Procedure: Extended Pouch RYGB; Roux-en-Y gastric bypass with an extended pouch; Other Names: EP-RYGB
Experimental: Banded Extended RYGB; 127 patients undergo a Roux-en-Y gastric bypass with a minimizer around the extended pouch.	Procedure: Banded extended pouch RYGB; Roux-en-Y gastric bypass with a banded extended pouch; Other Names: BEP-RYGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Total Body Weight Loss (%TBWL)	((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Excess Weight Loss (%EWL)	((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms	3 years
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.	3 years
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.	3 years
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	3 years
Gastroesophageal reflux disease	GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.	3 years
Change in comorbidities in patients pre- and postoperative	Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA	3 years

Collaborators and Investigators

• Sponsor: Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2028

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: NL62168.091.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No