Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/02/2007
Date assigned
06/07/2007
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes