Banded Versus Non-banded Roux-en-y Gastric Bypass | NCT02545647

Studies
Banded Versus Non-banded Roux-en-y Gastric Bypass

NCT02545647

Sponsor

Rijnstate Hospital

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

130Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

BRYGB

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

May 2019Actual

Completion Date

May 2023Actual

First Submitted Date

Sep 3, 2015

First Submission Date that Met QC Criteria

Sep 7, 2015

First Posted Date

Sep 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2024

Last Update Posted Date

Jun 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Roux-en-Y Gastric Bypass (RYGB) 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 pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

Detailed Description

The Study design is a prospective, randomized, single center study.

Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB 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 RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard RYGB	No Intervention	65 patients undergo a standard Roux-en-Y gastric bypass
Banded RYGB	Active Comparator	65 patients undergo a banded RYGB (BRYGB)	Device: BRYGB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BRYGB	Device	65 patients undergo a banded RYGB	Banded RYGB	banded RYGB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage total body weight loss (%TBWL)	weight loss is measured in kilogram.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage excess weight loss (%EWL)	excess weight loss is measured in kilogram.	3 years
percentage total body weight regain (%TBWR)	Weight regain is measured in kilogram.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients who are eligible for a primary RYGB

Exclusion Criteria:

Bariatric surgery in history
Patients with a language barrier which may affect the compliance with medical advice
Any kind of genetic disorders which can be of influence on the monitoring of 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
Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate Hospital		Arnhem		6800WC	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided