Contact information
Type
Scientific
Primary contact
Dr Gianpiero Gravante
ORCID ID
Contact details
via U.Maddalena 40/a
Ciampino
00043
Italy
ggravante@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
403-4
Study information
Scientific title
Acronym
400LAGB
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Obesity with BMI over 35
Intervention
Lap-Band (Laparoscopic adjustable gastric banding) versus Swedish gastric banding for obesity surgery.
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measures
Weight loss and BMI reduction, assessed every six months from surgery.
Secondary outcome measures
Complications prevalence and types.
Overall trial start date
12/11/2002
Overall trial end date
12/11/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant 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
Recruitment start date
12/11/2002
Recruitment end date
12/11/2005
Locations
Countries of recruitment
Italy, United Kingdom
Trial participating centre
via U.Maddalena 40/a
Ciampino
00043
Italy
Sponsor information
Organisation
Dolan Park Hospital (UK)
Sponsor details
Stoney Lane
Tadderbige
Bromsgrove
Worcestershire
B45 6FN
United Kingdom
mlacey@thehospitalgroup.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Dolan Park Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17938309
Publication citations
-
Results
Gravante G, Araco A, Araco F, Delogu D, De Lorenzo A, Cervelli V, Laparoscopic adjustable gastric bandings: a prospective randomized study of 400 operations performed with 2 different devices., Arch Surg, 2007, 142, 10, 958-961, doi: 10.1001/archsurg.142.10.958.