Laparoscopic adjustable gastric bandings: a prospective randomised study of 400 operations performed with two different devices

ISRCTN ISRCTN22839090
DOI https://doi.org/10.1186/ISRCTN22839090
Secondary identifying numbers 403-4
Submission date
04/02/2007
Registration date
06/07/2007
Last edited
06/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gianpiero Gravante
Scientific

via U.Maddalena 40/a
Ciampino
00043
Italy

Email ggravante@hotmail.com

Study information

Study designProspective randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronym400LAGB
Study objectivesTo evaluate eventual differences between the Lap-Band and the Swedish gastric banding for obesity surgery.
Ethics approval(s)No ethics approval required as the interventions involved only well known procedures with widely used devices for the management of obese patients.
Health condition(s) or problem(s) studiedObesity with BMI over 35
InterventionLap-Band (Laparoscopic adjustable gastric banding) versus Swedish gastric banding for obesity surgery.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureWeight loss and BMI reduction, assessed every six months from surgery.
Secondary outcome measuresComplications prevalence and types.
Overall study start date12/11/2002
Completion date12/11/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants400
Key inclusion criteriaAll 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
Key exclusion criteria1. 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
Date of first enrolment12/11/2002
Date of final enrolment12/11/2005

Locations

Countries of recruitment

  • Italy
  • United Kingdom

Study participating centre

via U.Maddalena 40/a
Ciampino
00043
Italy

Sponsor information

Dolan Park Hospital (UK)
Hospital/treatment centre

Stoney Lane
Tadderbige
Bromsgrove
Worcestershire
B45 6FN
England
United Kingdom

Email mlacey@thehospitalgroup.org
ROR logo "ROR" https://ror.org/03be8p176

Funders

Funder type

Hospital/treatment centre

Dolan Park Hospital (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/10/2007 Yes No