Contact information
Type
Scientific
Primary contact
Dr Masaba Joseph Benon
ORCID ID
Contact details
Department of Surgery
Mulago Hospital
Po Box 7051
Kampala
256
Uganda
+256 77536089
jmasaba@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Acronym
ECMVTMB: RCT
Study hypothesis
There is no clinical advantage of modified retropubic prostatectomy over transvesical prostatectomy.
Ethics approval
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
Study design
Non-blinded, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Benign prostatic hyperplasia
Intervention
1. Modified retropubic prostatectomy
2. Transvesical prostatectomy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Blood loss determined by haemoglobin and haematocrit levels on the third post operative day
Secondary outcome measures
1. Wound sepsis following surgery
2. Rate of return to operating theatre for clot retention
Overall trial start date
01/08/2007
Overall trial end date
28/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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%
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
68
Participant exclusion criteria
1. Suspected prostatic carcinoma
2. Renal failure
3. Cardiac disease
4. Abnormal bleeding tendencies
Recruitment start date
01/08/2007
Recruitment end date
28/02/2008
Locations
Countries of recruitment
Uganda
Trial participating centre
Department of Surgery
Kampala
256
Uganda
Funders
Funder type
Hospital/treatment centre
Funder name
Mulago Hospital (Uganda)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Resources of Investigator as part of Masters' thesis in surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list