Home
 


Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR2010010001793131 Date registered: 2009/12/07
TRIAL DESCRIPTION
Public title The use of three methods for endoscopic removal of prostate
Official scientific title A Randomized Comparison between three types of irrigating fluids during Transurethral Resection in Benign Prostatic Hyperplasia
Brief summary describing the background
and objectives of the trial
The comparison of three types of irrigating fluids during Transurethral Resection of the prostate
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 360   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Group 1 - 5% glucose 10 litres 24 hours 5% glucose 120
Experimental group Group 2 - Glycine 1.5% 10 litres 24 hours Glycine 1.5% 120
Control group Control - Saline .9% Not Indicated Not Indicated Not Indicated 120 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Adult male patients suffering from moderate to severe urinary outlet obstruction due to benign prostatic hyperplasia any contraindication to regional aneshtesia, sepsis, coagulopathy 18 Years 80 Years Male

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2009/11/02 Ethical Commitee of University of Tanta
Ethics Committee Address
Street address City Postal code Country
El-Guish street Tanta Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemaglobin Before, during and after treatment
Primary Outcome serum sodium before, during and after treatment
Primary Outcome TURP Syndrome before, during and after treatment
Secondary Outcome Serum glucose before, during and after treatment
Secondary Outcome serum potassium before, during and after treatment

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Urology Department, University of Tanta El-guish street Tanta Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Elguish Street Tanta Egypt
Tanta University Elguish Street Tanta Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Elguish Street Tanta Egypt Hospital
Primary Sponsor Tanta University Elguish Street Tanta Egypt Hospital

COLLABORATORS
Name Street address City Postal code Country
Ghada Abdulmomen Elemam Moslem Street Tanta Egypt
Mahmoud el sharaby Elestad Street Tanta Egypt
Abdelnaser Elgamasy El-Fateh Street Tanta Egypt
Ghada Abdulmomen Elemam Moslem Street Tanta Egypt
Mahmoud el sharaby Elestad Street Tanta Egypt
Abdelnaser Elgamasy El-Fateh Street Tanta Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Ayman Abd El-maksoud Yousef ayman.yousef@rocketmail.com 0020103497767 0020403328004
Street address City Postal code Country Position / Affiliation
17 El-Emam Moslem Street Tanta Egypt lecturer of Anesthesiology
Role Name Email Phone Fax
Public Enquiries Dr Ayman Abd El-maksoud Yousef ayman.yousef@rocketmail.com 0020103497767 0020403328004
Street address City Postal code Country Position / Affiliation
17 El-Emam Moslem Street Tanta Egypt Lecturer of Anesthesiology
Role Name Email Phone Fax
Scientific Enquiries Dr Ayman Abd El-maksoud Yousef ayman.yousef@rocketmail.com 0020103497767 0020403328004
Street address City Postal code Country Position / Affiliation
17 El-Emam Moslem Street Tanta Egypt Lecturer of Anesthesiology