Creating a Laparoscopic Banded Sleeve Gastrectomy (RING)
Primary Purpose
Morbid Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Banded Sleeve Gastrectomy
Standard SG
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Rijnstate HospitalRecruiting
- Zuyderland Medisch CentrumRecruiting
- St. Antonius Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard SG
Banded SG
Arm Description
100 patients undergo a standard sleeve gastrectomy
100 patients undergo a banded sleeve gastrectomy
Outcomes
Primary Outcome Measures
Percentage Total Body Weight loss (%TBWL)
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
Secondary Outcome Measures
Percentage Excess Weight Loss (%EWL)
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
Quality of life due to questionnaire
Measuring BAROS
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.
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
Gastroesophageal reflux disease
Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Reduction of comorbidities
Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04610099
Brief Title
Creating a Laparoscopic Banded Sleeve Gastrectomy
Acronym
RING
Official Title
Creating a Laparoscopic Banded Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard SG
Arm Type
Active Comparator
Arm Description
100 patients undergo a standard sleeve gastrectomy
Arm Title
Banded SG
Arm Type
Experimental
Arm Description
100 patients undergo a banded sleeve gastrectomy
Intervention Type
Device
Intervention Name(s)
Banded Sleeve Gastrectomy
Other Intervention Name(s)
BSG
Intervention Description
banded sleeve gastrectomy
Intervention Type
Device
Intervention Name(s)
Standard SG
Intervention Description
Standard SG
Primary Outcome Measure Information:
Title
Percentage Total Body Weight loss (%TBWL)
Description
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percentage Excess Weight Loss (%EWL)
Description
((Preoperative weight - current weight) / (preoperative weight - ideal weight at BMI 25)) x 100%. Weight loss measured in kilograms
Time Frame
3 years
Title
Quality of life due to questionnaire
Description
Measuring BAROS
Time Frame
3 years
Title
Quality of life due to questionnaire
Description
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
Title
Quality of life due to questionnaire
Description
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
Title
Gastroesophageal reflux disease
Description
Measuring GERD-HRQL questionnaire, a higher score on the questionnaire indicates more complaints of gastroesophageal reflux disease.
Time Frame
3 years
Title
Reduction of comorbidities
Description
Measuring reduction of diabetes, hypertension, dyslipidemia, osteoarticular disease, OSA
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazebroek, MD, PhD
Phone
+31880055970
Email
info@vitalys.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazebroek
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazebroek
Phone
0880055970
Email
info@vitalys.nl
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E.G. Boerma
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wiezer
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Creating a Laparoscopic Banded Sleeve Gastrectomy
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