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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gianpiero Gravante
Scientific

via U.Maddalena 40/a
Ciampino
00043
Italy

Email	ggravante@hotmail.com

Study design	Prospective randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	400LAGB
Study objectives	To 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) studied	Obesity with BMI over 35
Intervention	Lap-Band (Laparoscopic adjustable gastric banding) versus Swedish gastric banding for obesity surgery.
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure	Weight loss and BMI reduction, assessed every six months from surgery.
Secondary outcome measures	Complications prevalence and types.
Overall study start date	12/11/2002
Completion date	12/11/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Key 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
Key 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
Date of first enrolment	12/11/2002
Date of final enrolment	12/11/2005

via U.Maddalena 40/a

Ciampino
00043
Italy

Dolan Park Hospital (UK)
Hospital/treatment centre

Stoney Lane
Tadderbige
Bromsgrove
Worcestershire
B45 6FN
England
United Kingdom

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

Hospital/treatment centre

Dolan Park Hospital (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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