Early Clinical outcome of Modified retropubic Versus Transvesical prostatectomy in Management of Benign prostatic hyperplasia: a Randomised Clinical Trial
| ISRCTN | ISRCTN78922760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78922760 |
| Protocol serial number | 001 |
| Sponsor | Mulago Hospital (Uganda) |
| Funders | Mulago Hospital (Uganda), Resources of Investigator as part of Masters' thesis in surgery |
- Submission date
- 20/08/2007
- Registration date
- 10/07/2008
- Last edited
- 11/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 Masaba Joseph Benon
Scientific
Scientific
Department of Surgery
Mulago Hospital
Po Box 7051
Kampala
256
Uganda
| Phone | +256 77536089 |
|---|---|
| jmasaba@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-blinded, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | ECMVTMB: RCT |
| Study objectives | There is no clinical advantage of modified retropubic prostatectomy over transvesical prostatectomy. |
| Ethics approval(s) | 1. Research and Ethics Committee of the Faculty of Medicine, Makerere University. Date of approval: 30/07/2007 2. The Mulago National Referral Hospital Research and Ethics Committee. Date of approval: 30/07/2007 |
| Health condition(s) or problem(s) studied | Benign prostatic hyperplasia |
| Intervention | 1. Modified retropubic prostatectomy 2. Transvesical prostatectomy |
| Intervention type | Other |
| Primary outcome measure(s) |
Blood loss determined by haemoglobin and haematocrit levels on the third post operative day |
| Key secondary outcome measure(s) |
1. Wound sepsis following surgery |
| Completion date | 28/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 68 |
| Key inclusion criteria | 1. Patients admitted between August 2007 and March 2008 with diagnosis of Benign Prostatic Hyperplasia (BPH) 2. Haemoglobin level of 10 g/dL or more 3. Haematocrit of more than 30% |
| Key exclusion criteria | 1. Suspected prostatic carcinoma 2. Renal failure 3. Cardiac disease 4. Abnormal bleeding tendencies |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 28/02/2008 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Department of Surgery
Kampala
256
Uganda
256
Uganda
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
