Single-incision transumbilical laparoscopic Roux-en-Y gastric bypass
| ISRCTN | ISRCTN92780988 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92780988 |
| Secondary identifying numbers | EMRP17098N |
- Submission date
- 27/09/2010
- Registration date
- 07/10/2010
- Last edited
- 07/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Yi-Da Road
Kaohsiung County
824
Taiwan
Study information
| Study design | Prospective non-randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Single-incision transumbilical laparoscopic Roux-en-Y gastric bypass: a prospective non-randomised controlled study |
| Study objectives | 1. To evaluate the feasibility and safety of single-incision transumbilical laparoscopic Roux-en-Y gastric bypass 2.To compare the surgical outcome of the single incision transumbilical and 5-ports laparoscopic Roux-en-Y gastric bypass |
| Ethics approval(s) | E-Da Institutional Review Board (IRB) approved on the 13th August 2009 (ref: EMRP17098N) |
| Health condition(s) or problem(s) studied | Morbid obesity/type II diabetes meliitus |
| Intervention | The study prospectively compares single incision transumbilical laparoscopic Roux en Y gastric bypass (intervention arm) and conventional 5-port laparoscopic Roux en Y gastric bypass (control arm). Patients can choose which surgery they prefer for themselves. The total duration for treatment is 2 years and all patients are followed 2 years. |
| Intervention type | Other |
| Primary outcome measure | Measured peri-operatively and 3 months post-operatively: 1. Operation time 2. Intra-operative complication 3. Post-operative complication 4. Analgesic use 5. Hospitalisation |
| Secondary outcome measures | 1. Excess weight loss in first year, measured at 1, 3, 6, 9 and 12 months 2. Wound satisfaction, measured at 3 months |
| Overall study start date | 01/11/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 patients |
| Key inclusion criteria | All patients (aged 18 - 65 years, either sex) considered for laparoscopic Roux-en-Y gastric bypass as the treatment method for morbid obesity or Type II Diabetes mellitus |
| Key exclusion criteria | 1. Body mass index (BMI) greater than 50 2. Body height greater than 180 cm |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Yi-Da Road
Kaohsiung County
824
Taiwan
824
Taiwan
Sponsor information
E-Da Hospital (Taiwan)
Hospital/treatment centre
Hospital/treatment centre
1 Yi-Da Road
Kaohsiung County
824
Taiwan
| Website | http://www.edah-hospital.com |
|---|---|
"ROR" |
https://ror.org/00eh7f421 |
Funders
Funder type
Hospital/treatment centre
E-Da Hospital (Taiwan)
No information available
Results and Publications
| 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 |
