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 |
| Protocol serial number | 403-4 |
| Sponsor | Dolan Park Hospital (UK) |
| Funder | Dolan Park Hospital (UK) |
- 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
Scientific
via U.Maddalena 40/a
Ciampino
00043
Italy
| ggravante@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Weight loss and BMI reduction, assessed every six months from surgery. |
| Key secondary outcome measure(s) |
Complications prevalence and types. |
| Completion date | 12/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- Italy
Study participating centre
via U.Maddalena 40/a
Ciampino
00043
Italy
00043
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
