Extending and Banding the Roux-en-Y Gastric Bypass

N/AActive Not RecruitingNCT05357807

Rijnstate Hospital375 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

375

Conditions

Morbid Obesity

Interventions

Standard RYGBPROCEDURE

Roux-en-Y Gastric bypass

Extended Pouch RYGBPROCEDURE

Roux-en-Y gastric bypass with an extended pouch

Banded extended pouch RYGBPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

NOK West

The Hague, Netherlands

Outcomes

Primary Outcomes

Percentage Total Body Weight Loss (%TBWL)

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

Time frame: 3 years

Secondary Outcomes

Percentage Excess Weight Loss (%EWL)

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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