Creating a Laparoscopic Banded Sleeve Gastrectomy
RING
1 other identifier
interventional
211
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJune 28, 2024
June 1, 2024
5.3 years
October 26, 2020
June 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage Total Body Weight loss (%TBWL)
((preoperative weight - current weight) / (preoperative weight)) x 100%. Weight loss measured in kilograms
3 years
Secondary Outcomes (6)
Percentage Excess Weight Loss (%EWL)
3 years
Quality of life due to questionnaire
3 years
Quality of life due to questionnaire
3 years
Quality of life due to questionnaire
3 years
Gastroesophageal reflux disease
3 years
- +1 more secondary outcomes
Study Arms (2)
Standard SG
ACTIVE COMPARATOR100 patients undergo a standard sleeve gastrectomy
Banded SG
EXPERIMENTAL100 patients undergo a banded sleeve gastrectomy
Interventions
Eligibility Criteria
You may qualify if:
- Alle patients who are eligible for a primary SG
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rijnstate Hospital
Arnhem, Gelderland, 6815AD, Netherlands
Zuyderland Medisch Centrum
Heerlen, Limburg, 6419PC, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435CM, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hazebroek
Rijnstate Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 30, 2020
Study Start
September 1, 2020
Primary Completion
December 31, 2025
Study Completion
March 1, 2026
Last Updated
June 28, 2024
Record last verified: 2024-06