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

NCT01015469 | Unknown Phase 4

• 2 other identifiers: IT5448081EudraCT-No. 2009-016718-26
• Study Type: interventional
• Target: 384
• Locations: 7 countries
• Sites: 14

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.

Conditions

Morbid Obesity Requiring Bariatric Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Procedure: Conventional laparoscopic Roux-en-Y gastric bypass

Group B

EXPERIMENTAL

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

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

Interventions

Conventional laparoscopic Roux-en-Y gastric bypass PROCEDURE

Conventional laparoscopic Roux-en-Y gastric bypass

Group A

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

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

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ClinTrio Ltd.: lead

Study Sites (14)

Hospital Hallein (Scientific Review Board)

Hallein, 5400, Austria

ACTIVE NOT RECRUITING

Hospital AZ St.-Jan AV

Bruges, 8000, Belgium

RECRUITING

AZ Sint-Blasius

Dendermonde, 9200, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

RECRUITING

Privatpraxis Chirurgie bei Schlossparkklinik

Berlin, 14059, Germany

RECRUITING

Albert-Ludwigs-University

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246, Germany

RECRUITING

Chirurgische Klinik München-Bogenhausen GmbH

München, 81679, Germany

RECRUITING

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78011, Germany

RECRUITING

Atruim Medical Centre

Heerlen, 6401, Netherlands

RECRUITING

Medical University of Lodz

Lodz, 90-152, Poland

RECRUITING

Centro Hospitalar de Lisboa Central

Lisbon, 1150-199, Portugal

RECRUITING

Hospital de Sao Sebastiano

Santa Maria de Feira, 4520-211, Portugal

RECRUITING

International Medical Center

Jeddah, 2172, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Konrad W Karcz, MD

  Albert-Ludwigs-University of Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burkhart Frankenberger

CONTACT

+49-511-38814-0; info@clintrio.com

Maria Noraman

CONTACT

+49-511-38814-0; m.noraman@clintrio.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: February 17, 2011

Record last verified: 2011-02

Locations

DE (5); AU (1); BE (3); PL (1); PT (2); NL (1); SA (1)