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
Secondary identifying numbers 001
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

Department of Surgery
Mulago Hospital
Po Box 7051
Kampala
256
Uganda

Phone +256 77536089
Email jmasaba@gmail.com

Study information

Study designNon-blinded, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymECMVTMB: RCT
Study objectivesThere 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) studiedBenign prostatic hyperplasia
Intervention1. Modified retropubic prostatectomy
2. Transvesical prostatectomy
Intervention typeOther
Primary outcome measureBlood loss determined by haemoglobin and haematocrit levels on the third post operative day
Secondary outcome measures1. Wound sepsis following surgery
2. Rate of return to operating theatre for clot retention
Overall study start date01/08/2007
Completion date28/02/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants68
Key inclusion criteria1. 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 criteria1. Suspected prostatic carcinoma
2. Renal failure
3. Cardiac disease
4. Abnormal bleeding tendencies
Date of first enrolment01/08/2007
Date of final enrolment28/02/2008

Locations

Countries of recruitment

  • Uganda

Study participating centre

Department of Surgery
Kampala
256
Uganda

Sponsor information

Mulago Hospital (Uganda)
Hospital/treatment centre

Po Box 7051
Kampala
256
Uganda

ROR logo "ROR" https://ror.org/02rhp5f96

Funders

Funder type

Hospital/treatment centre

Mulago Hospital (Uganda)

No information available

Resources of Investigator as part of Masters' thesis in surgery

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan