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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.: PACTR201212000471432 Date registered: 2012/12/12
TRIAL DESCRIPTION
Public title Glucose irrigation for hysteroscopy
Official scientific title The use of glucose 5% as irrigating fluid during hysteroscopy reduces the incidence of hyponatraemic encephalopathy. Double blinded randomized study.
Brief summary describing the background
and objectives of the trial
100 patients will be equally randomized in 2 groups according to irrigation fluid used. 50 patients will glycine 1.5% solution (glycine grp) and 50 will use glucose 5% solution (glucose grp. Patient demographics, operative time, hospital stay, postoperatie amino acid glycine assay and perioperative complications will be observed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2012-11-15
Actual trial start date 2012-11-15
Anticipated date of last follow up 2012-11-30
Actual date of last follow up 2012-11-30
Anticipated target sample size (number of participants) 100   
Actual target sample size (number of participants)   
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 sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Glycine 1.5% 10L as irrigating fluid 24 hours Glycine group 50 Active
Experimental group Glucose 5% 10L 2 hours Glocose group 50

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
A total of 100 patients undergoing operative hysteroscopy at Gynecology dept, Tanta University Hospitals Patients younger than 18 and older than 60 years 18 Years 60 Years Female

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 2012/10/30 Tanta University Ethics Commmittee
Ethics Committee Address
Street address City Postal code Country
Tanta Univeristy, El-guish Street Tanta Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum Na pre and post-operative
Primary Outcome serum glucose pre and post-operative
Primary Outcome hematocrite level pre and post-operative
Secondary Outcome encephalopathy pre and post-operative
Secondary Outcome hematocrite level pre and post-operative

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine El-guish Street Tanta Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, University of Tanta El-guish Street Tanta Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Tanta El-guish Street Tanta Egypt University

COLLABORATORS
Name Street address City Postal code Country
Hesham Abdelaziz Salem El-guish Street Tanta Egypt
Ghada Abdulmomem Suliman El-guish Street Tanta Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 00201003318113
Street address City Postal code Country Position / Affiliation
17 elemam moslem Street Tanta Egypt
Role Name Email Phone Fax
Scientific Enquiries Prof Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 00201003318113
Street address City Postal code Country Position / Affiliation
17 elemam moslem Street Tanta Egypt Assistant Professor of Anesthesia
Role Name Email Phone Fax
Principal Investigator Prof Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 00201003318113
Street address City Postal code Country Position / Affiliation
17 elemam moslem Street Tanta Egypt Assistant Professor of Anesthesia