|
ISRCTN
|
ISRCTN22839090
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Laparoscopic adjustable gastric bandings: a prospective randomised study of 400 operations performed with two different devices
|
|
Scientific title
|
|
|
Acronym
|
400LAGB
|
|
Serial number at source
|
403-4
|
|
Study hypothesis
|
To evaluate eventual differences between the Lap-Band and the Swedish gastric banding for obesity surgery.
|
|
Ethics approval
|
No ethics approval required as the interventions involved only well known procedures with widely used devices for the management of obese patients.
|
|
Study design
|
Prospective randomised trial
|
|
Countries of recruitment
|
Italy, United Kingdom
|
|
Disease/condition/study domain
|
Obesity with BMI over 35
|
|
Participants - inclusion criteria
|
All patients were considered eligible for bariatric surgery with:
1. A Body Mass Index (BMI: kg/m^2) greater than 40
2. BMI between 35 and 40 with associated comorbities
3. Patients with BMI greater than 60 that could not undergo derivative procedures
|
|
Participants - exclusion criteria
|
1. BMI greater than 60 (fit for derivative procedures)
2. Previous surgery on the upper abdomen
3. Psychiatric illnesses that could endanger a close postoperative follow-up
|
|
Anticipated start date
|
12/11/2002
|
|
Anticipated end date
|
12/11/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
400
|
|
Interventions
|
Lap-Band (Laparoscopic adjustable gastric banding) versus Swedish gastric banding for obesity surgery.
|
|
Primary outcome measure(s)
|
Weight loss and BMI reduction, assessed every six months from surgery.
|
|
Secondary outcome measure(s)
|
Complications prevalence and types.
|
|
Sources of funding
|
Dolan Park Hospital (UK)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17938309
|
|
Contact name
|
Dr
Gianpiero
Gravante
|
|
Address
|
via U.Maddalena 40/a
|
|
City/town
|
Ciampino
|
|
Zip/Postcode
|
00043
|
|
Country
|
Italy
|
|
Email
|
ggravante@hotmail.com
|
|
Sponsor
|
Dolan Park Hospital (UK)
|
|
Address
|
Stoney Lane
Tadderbige
Bromsgrove
|
|
City/town
|
Worcestershire
|
|
Zip/Postcode
|
B45 6FN
|
|
Country
|
United Kingdom
|
|
Email
|
mlacey@thehospitalgroup.org
|
|
Date applied
|
04/02/2007
|
|
Last edited
|
06/08/2008
|
|
Date ISRCTN assigned
|
06/07/2007
|
