RING: Creating a Laparoscopic Banded Sleeve Gastrectomy

Sponsor

Rijnstate Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04610099

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Device: Banded Sleeve Gastrectomy Device: Standard SG	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Creating a Laparoscopic Banded Sleeve Gastrectomy

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard SG 100 patients undergo a standard sleeve gastrectomy	Device: Standard SG Standard SG
Experimental: Banded SG 100 patients undergo a banded sleeve gastrectomy	Device: Banded Sleeve Gastrectomy banded sleeve gastrectomy Other Names: BSG

Arm

Intervention/Treatment

Active Comparator: Standard SG

100 patients undergo a standard sleeve gastrectomy

Device: Standard SG

Standard SG

Experimental: Banded SG

100 patients undergo a banded sleeve gastrectomy

Device: Banded Sleeve Gastrectomy

banded sleeve gastrectomy

Other Names:

BSG

Outcome Measures

Primary Outcome Measures

Percentage Total Body Weight loss (%TBWL) [3 years]
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms

Secondary Outcome Measures

Percentage Excess Weight Loss (%EWL) [3 years]
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
Quality of life due to questionnaire [3 years]
Measuring BAROS
Quality of life due to questionnaire [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.
Quality of life due to questionnaire [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
Gastroesophageal reflux disease [3 years]
Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Reduction of comorbidities [3 years]
Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem	Gelderland	Netherlands	6815AD
2	Zuyderland Medisch Centrum	Heerlen	Limburg	Netherlands	6419PC
3	St. Antonius Ziekenhuis	Nieuwegein	Utrecht	Netherlands	3435CM

Sponsors and Collaborators

Rijnstate Hospital

Investigators

Principal Investigator: Hazebroek, Rijnstate Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rijnstate Hospital

ClinicalTrials.gov Identifier:

NCT04610099

Other Study ID Numbers:

NL70754.091.19

First Posted:

Oct 30, 2020

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of May 2, 2022