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: pactr.samrc.ac.za
Trial no.: PACTR2010010001793131 Date of Approval: 07/12/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Prostate Hyperplasia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2010
Actual trial start date
Anticipated date of last follow up 10/01/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
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 Care giver/Provider,Participants
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 80 Year(s) 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 02/11/2009 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
Ghada Abdulmomen Elemam Moslem Street Tanta Egypt
Mahmoud el sharaby Elestad Street Tanta Egypt
Mahmoud el sharaby Elestad Street Tanta Egypt
Abdelnaser Elgamasy El-Fateh Street Tanta Egypt
Abdelnaser Elgamasy El-Fateh Street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Abd El-maksoud Yousef ayman.yousef@rocketmail.com 0020103497767 17 El-Emam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of Anesthesiology
Role Name Email Phone Street address
Public Enquiries Ayman Abd El-maksoud Yousef ayman.yousef@rocketmail.com 0020103497767 17 El-Emam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Ayman Abd El-maksoud Yousef ayman.yousef@rocketmail.com 0020103497767 17 El-Emam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information