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.: PACTR201503001023100 Date of Approval: 01/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ligation anopexy versus doppler guided haemorroidal artery ligation
Official scientific title ligation anopexy versus doppler guided haemorroidal artery ligation in treatment of grade III Hemorroidal disease
Brief summary describing the background and objectives of the trial The objective of the study was to compare ligation anopexy (LA) and Haemorroidal artery ligation (HAL) in treatment of 2nd & 3rd degree hemorrhoids
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,hemorroidal disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/02/2015
Actual trial start date 02/02/2015
Anticipated date of last follow up 01/04/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status 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 radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ligation anopexy ligation of hemorroidal vessels at anatomical site 100
Control Group doppler guided hamorroid using doppler for hemorroidal artery ligation 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with symptomatic second and third degree hemorrhoids requiring hemorroidectomy after failure of conservative treatment or office based procedures (rubber band ligation or sclerotherapy) were included in the trial. Patients between 18 to 71 years of age were included. Patients excluded if they had acute thrombosed piles, previous hemorrhoidectomy, anal stricture, fissure in ano, fistula in ano, faecal incontinence, medical conditions which made the patients unfit for elective surgery 18 Year(s) 71 Year(s) Both
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 02/02/2015 Alexandria University ethical committe
Ethics Committee Address
Street address City Postal code Country
El azzarita, EL mery hospital Alexandria 21111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative pain All Patients were followed up in the outpatient clinic at seven, 14, 21, 28 days
Secondary Outcome recurrence recurrence of hemorroidal symptoms after 6 mornths at least of either bleeding or prolpase
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Colorectal unit alexandria university EL azzaritta, Alexandria , Egypt Alexandria 21111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria main university hospital El azzaitta Alexandria 21111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria university El azzritta Alexandria 21123 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Alexandria main university hospital El azzaritta Alexandria 21111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator walid elshazly wshazly@hotmail.com 034812434 El azzaritta
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt prof
Role Name Email Phone Street address
Public Enquiries isra aly israa.aly@alexmed.edu.eg 034812454 El azzaritta
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries walid el bana wshazly@gmail.com 034845434 El azzaritta
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Prof
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