Creating a Laparoscopic Banded Sleeve Gastrectomy

Morbid Obesity Clinical Trial

— RING  

Official title:

Creating a Laparoscopic Banded Sleeve Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610099
• Other study ID #: NL70754.091.19
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2025

Study information

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

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• Banded Sleeve Gastrectomy
banded sleeve gastrectomy
• Standard SG
Standard SG

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Zuyderland Medisch Centrum	Heerlen	Limburg
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	Quality of life due to questionnaire	Measuring BAROS	3 years
Secondary	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.	3 years
Secondary	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	3 years
Secondary	Gastroesophageal reflux disease	Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.	3 years
Secondary	Reduction of comorbidities	Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA	3 years