Creating a Laparoscopic Banded Sleeve Gastrectomy

N/AActive Not RecruitingNCT04610099

Rijnstate Hospital211 enrolled

Overview

A Sleeve Gastrectomy (SG) 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 sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy. Study is a prospective, randomized, multi centre trial. Study population: patients who qualify for a SG are eligible to participate. The primary SG 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 SG is compared with a banded-SG (BSG)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

211

Conditions

Morbid Obesity

Interventions

Banded Sleeve GastrectomyDEVICE

banded sleeve gastrectomy

Standard SGDEVICE

Standard SG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Alle patients who are eligible for a primary SG Exclusion Criteria: * Bariatric surgery in medical history * BMI \> 60kg/m2 or a planned two-stage procedure. * 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) or hepatic dysfunction (liver function twice the normal values) * Pregnancy during follow-up * Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

Locations (3)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Zuyderland Medisch Centrum

Heerlen, Limburg, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 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

Quality of life due to questionnaire

Measuring BAROS

Time frame: 3 years

Quality of life due to questionnaire

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

Quality of life due to questionnaire

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

Time frame: 3 years

Gastroesophageal reflux disease

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

Data from ClinicalTrials.gov

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