Condition category
Urological and Genital Diseases
Date applied
20/08/2007
Date assigned
10/07/2008
Last edited
11/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Mulago Hospital (Uganda)

Sponsor details

Po Box 7051
Kampala
256
Uganda
-

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes