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Completed

NCT Number: NCT02545647

Banded Versus Non-banded Roux-en-y Gastric Bypass

A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, 6800WC, Netherlands

About this study

A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

The Study design is a prospective, randomized, single center study.

Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.

Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)

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 history
  • Patients with a language barrier which may affect the compliance with medical advice
  • Any kind of genetic disorders which can be of influence on the monitoring of 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) or hepatic dysfunction (liver function twice the normal values)
  • Pregnancy
  • Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

Treatment and study plan

BRYGB

Device

65 patients undergo a banded RYGB

Other names: banded RYGB

Primary outcomes

  1. Percentage total body weight loss (%TBWL)

    Time frame: 3 years

    weight loss is measured in kilogram.

Secondary outcomes

  1. Percentage excess weight loss (%EWL)

    Time frame: 3 years

    excess weight loss is measured in kilogram.

  2. percentage total body weight regain (%TBWR)

    Time frame: 3 years

    Weight regain is measured in kilogram.

  3. Decrease in type 2 diabetes mellitus

    Time frame: 3 years

    measuring glycated hemoglobin, decrease in diabetic medication

  4. Quality of life

    Time frame: 3 years

    measuring BAROS score

  5. Decrease in dyslipidaemia

    Time frame: 3 years

    decrease in medication for hypercholesterolaemie. Measuring cholesterol spectrum.

  6. Decrease in hypertension

    Time frame: 3 years

    Measuring blood pressure

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

Banded Versus Non-banded Roux-en-y Gastric Bypass, a Randomised Controlled Trial

Acronym: Bandolera

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Sep 10, 2015
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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