Laparoscopic adjustable banded gastric plication in morbid obesity
| ISRCTN | ISRCTN17213539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17213539 |
| Protocol serial number | EMRP22098N |
| Sponsor | E-DA Hospital (Taiwan) |
| Funder | E-Da hospital (Taiwan) |
- Submission date
- 21/09/2010
- Registration date
- 07/10/2010
- Last edited
- 07/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chih-Kun Huang
Scientific
Scientific
1 Yi-Da Road
Kaohsiung county
824
Taiwan
| Phone | +886 (0)9 36263146 |
|---|---|
| dr.ckhuang@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective cohort trial |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Laparoscopic adjustable banded gastric plication in morbid obesity: a prospective study |
| Study objectives | To evaluate the safety and weight loss effect of laparoscopic adjustable banded gastric plication (LABGAP) |
| Ethics approval(s) | The E-Da Institutional Review Board (IRB) approved on the 11th of May 2009 (ref: EMRP22098N) |
| Health condition(s) or problem(s) studied | Morbid obesity |
| Intervention | Gastric banding combined with total greater curvature plication. This is a single arm trial to evaluate the results and complications associated with the LABGAP. The total duration of follow up is 2 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Weight loss and BMI reduction, assessed every 3 months from surgery |
| Key secondary outcome measure(s) |
Complication and management of surgery |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Body Mass Index (BMI: kg/m^2) greater than 40 2. BMI between 35 and 40 with associated comorbidities 3. Age 18-65, either sex |
| Key exclusion criteria | 1. Substance abuse 2. Psychiatric illnesses that could endanger a close postoperative follow-up 3. History of allergic to silicon materials |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- China
- Taiwan
Study participating centre
1 Yi-Da Road
Kaohsiung county
824
Taiwan
824
Taiwan
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
