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Active, Not Recruiting

NCT Number: NCT05357807

Extending and Banding the Roux-en-Y Gastric Bypass

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard RYGB

Procedure

Roux-en-Y Gastric bypass

Other names: S-RYGB

Extended Pouch RYGB

Procedure

Roux-en-Y gastric bypass with an extended pouch

Other names: EP-RYGB

Banded extended pouch RYGB

Procedure

Roux-en-Y gastric bypass with a banded extended pouch

Other names: BEP-RYGB

Primary outcomes

  1. Percentage Total Body Weight Loss (%TBWL)

    Time frame: 3 years

    ((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms

Secondary outcomes

  1. Percentage Excess Weight Loss (%EWL)

    Time frame: 3 years

    ((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms

  2. BODY-Q: Quality of life after bariatric surgery

    Time frame: 3 years

    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. BAROS: Quality of life after bariatric surgery

    Time frame: 3 years

    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.

  4. SF-36: Quality of life after bariatric surgery

    Time frame: 3 years

    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

  5. Gastroesophageal reflux disease

    Time frame: 3 years

    GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.

  6. Change in comorbidities in patients pre- and postoperative

    Time frame: 3 years

    Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Acronym: UPGRADE

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
May 3, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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