Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04610099
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2020-10-26
Brief Title:
Creating a Laparoscopic Banded Sleeve Gastrectomy
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Creating a Laparoscopic Banded Sleeve Gastrectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RING
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None