Extending and Banding the Roux-en-Y Gastric Bypass

Morbid Obesity Clinical Trial

— UPGRADE  

Official title:

Extending and Banding the Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357807
• Other study ID #: NL62168.091.17
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2028

Study information

• Verified date: May 2022
• Source: Rijnstate Hospital
• Contact: Rijnstate Hazebroek
• Phone: +31880055970
• Email: info[@]vitalys.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 381
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Standard RYGB
Roux-en-Y Gastric bypass
• Extended Pouch RYGB
Roux-en-Y gastric bypass with an extended pouch
• Banded extended pouch RYGB
Roux-en-Y gastric bypass with a banded extended pouch

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	NOK West	Den Haag
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Total Body Weight Loss (%TBWL)	((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gastroesophageal reflux disease	GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.	3 years
Secondary	Change in comorbidities in patients pre- and postoperative	Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA	3 years