Creating a Laparoscopic Banded Sleeve Gastrectomy (RING)

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 Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Device: Standard SG; Device: Banded Sleeve Gastrectomy

Detailed 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)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazebroek, MD, PhD; Phone Number: +31880055970; Email: info@vitalys.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Recruiting
      • Rijnstate Hospital
      • Contact: Hazebroek; Phone Number: 0880055970; Email: info@vitalys.nl
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419PC
      • Recruiting
      • Zuyderland Medisch Centrum
      • Contact: E.G. Boerma
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • Not yet recruiting
      • St. Antonius Ziekenhuis
      • Contact: Wiezer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Total Body Weight loss (%TBWL)	((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of life due to questionnaire	Measuring BAROS	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.	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	3 years
Gastroesophageal reflux disease	Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.	3 years
Reduction of comorbidities	Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA	3 years

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Hazebroek, Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: NL70754.091.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No