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Banded Versus Conventional Laparoscopic Roux-en-Y (GABY) (GABY)

Primary Purpose

Morbid Obesity Requiring Bariatric Surgery

Status

Unknown status

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Conventional laparoscopic Roux-en-Y gastric bypass

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

About this trial

This is an interventional treatment trial for Morbid Obesity Requiring Bariatric Surgery focused on measuring bariatric, surgery, obesity, Roux-en-Y, gastric, medical device, bypass, adiposity, GaBP-Ring, BMI, banded, laparoscopic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

BMI ≥ 40 kg /m2 to ≤ 50 kg/m2
Eating habit: sweet eater and volume eater
Signed informed consent
Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet

Exclusion Criteria:

History of obesity surgery
History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
Patients not eligible to implement silastic ring size 6.5 cm
History of drug or alcohol abuse
History of major psychiatric illness conflicting with patient's compliance
History of recent or chronic steroid medication
Autoimmune disease
Inflammatory bowel disease or malabsorptive disease
Liver cirrhosis (CHILD B + C)
Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.)
Pregnant women or women with childbearing potential without efficient contraception
History of cancer in the last five years
Need of long-term anticoagulant medication for any reason
Any medication with ingredient ASA

Sites / Locations

Hospital Hallein (Scientific Review Board)
Hospital AZ St.-Jan AVRecruiting
AZ Sint-BlasiusRecruiting
AZ NikolaasRecruiting
Privatpraxis Chirurgie bei SchlossparkklinikRecruiting
Albert-Ludwigs-UniversityRecruiting
Universitätsklinikum Hamburg-Eppendorf (UKE)Recruiting
Chirurgische Klinik München-Bogenhausen GmbHRecruiting
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbHRecruiting
Atruim Medical CentreRecruiting
Medical University of LodzRecruiting
Centro Hospitalar de Lisboa CentralRecruiting
Hospital de Sao SebastianoRecruiting
International Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)

Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

Outcomes

Primary Outcome Measures

postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure

Secondary Outcome Measures

Full Information

NCT ID

NCT01015469

First Posted

November 17, 2009

Last Updated

February 16, 2011

Sponsor

ClinTrio Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01015469

Brief Title

Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

Acronym

GABY

Official Title

International, Multi Centre, Open, Prospective, Randomized Study: Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Unknown status

Study Start Date

February 2009 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

ClinTrio Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY). The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance. The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.

Detailed Description

GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass. At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years. Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity Requiring Bariatric Surgery

Keywords

bariatric, surgery, obesity, Roux-en-Y, gastric, medical device, bypass, adiposity, GaBP-Ring, BMI, banded, laparoscopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Conventional laparoscopic Roux-en-Y gastric bypass (Golden Standard)

Arm Title

Group B

Arm Type

Experimental

Arm Description

Conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

Intervention Type

Procedure

Intervention Name(s)

Conventional laparoscopic Roux-en-Y gastric bypass

Intervention Description

Conventional laparoscopic Roux-en-Y gastric bypass

Intervention Type

Procedure

Intervention Name(s)

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

Intervention Description

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)

Primary Outcome Measure Information:

Title

postoperative reduction of body mass index (BMI) and maintenance related to used bariatric procedure

Time Frame

0, 3, 6, 12 months and 2, 3, 4, 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI ≥ 40 kg /m2 to ≤ 50 kg/m2 Eating habit: sweet eater and volume eater Signed informed consent Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet Exclusion Criteria: History of obesity surgery History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy) Patients not eligible to implement silastic ring size 6.5 cm History of drug or alcohol abuse History of major psychiatric illness conflicting with patient's compliance History of recent or chronic steroid medication Autoimmune disease Inflammatory bowel disease or malabsorptive disease Liver cirrhosis (CHILD B + C) Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.) Pregnant women or women with childbearing potential without efficient contraception History of cancer in the last five years Need of long-term anticoagulant medication for any reason Any medication with ingredient ASA

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Burkhart Frankenberger

Phone

+49-511-38814-0

info@clintrio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Noraman

Phone

+49-511-38814-0

m.noraman@clintrio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konrad W Karcz, MD

Organizational Affiliation

Albert-Ludwigs-University of Freiburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Hallein (Scientific Review Board)

City

Hallein

ZIP/Postal Code

5400

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Hospital AZ St.-Jan AV

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno Dillemans, MD

Facility Name

AZ Sint-Blasius

City

Dendermonde

ZIP/Postal Code

9200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaques Himpens, MD

Facility Name

AZ Nikolaas

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luc Lemmens, MD

Facility Name

Privatpraxis Chirurgie bei Schlossparkklinik

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Volker Lange, Prof.

Facility Name

Albert-Ludwigs-University

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Konrad W Karcz, MD

Facility Name

Universitätsklinikum Hamburg-Eppendorf (UKE)

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Mann, MD

Facility Name

Chirurgische Klinik München-Bogenhausen GmbH

City

München

ZIP/Postal Code

81679

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Günther Meyer, MD

Facility Name

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

City

Villingen-Schwenningen

ZIP/Postal Code

78011

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert Runkel, Prof.

Facility Name

Atruim Medical Centre

City

Heerlen

ZIP/Postal Code

6401

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan W.M. Greve, MD

Facility Name

Medical University of Lodz

City

Lodz

ZIP/Postal Code

90-152

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomasz Szewczyk, MD

Facility Name

Centro Hospitalar de Lisboa Central

City

Lisboa

ZIP/Postal Code

1150-199

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui Ribeiro, MD

Facility Name

Hospital de Sao Sebastiano

City

Santa Maria de Feira

ZIP/Postal Code

4520-211

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mario Nora, MD

Facility Name

International Medical Center

City

Jeddah

ZIP/Postal Code

2172

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Walid Bukhari, MD

12. IPD Sharing Statement

Learn more about this trial

Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

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