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.: PACTR201403000769361 Date of Approval: 08/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ligation Anopexy in treatmeat hemoroidal disease.
Official scientific title Ligation Anopexy versus conventional hemoroidectomy in treatment of grade II and III hemoroidal disease.
Brief summary describing the background and objectives of the trial The objectives of the study were to compare ligation anopexy (LA) and conventional hemorrhoidectomy (CH) 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,hemoroidal disease,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2010
Actual trial start date 01/01/2011
Anticipated date of last follow up 08/06/2013
Actual Last follow-up date 08/06/2013
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Stopped early/ terminated
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 by computer software Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ligation anopexy 100 operative procedure 100
Control Group Conventional hemorroidectomy 100 The classical milligram Morgan hemorroidectomy 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 failed medical treatment age 18 to 71 years of age. Patients excluded if they had acute thrombosed piles previous hemorrhoidectomy anal stricture fissure in ano fistula in ano faecal incontinence medical conditions that made the patient unfit for elective surgery who had not consent to the trial. 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 01/01/2011 Alexandria Ethical Committee
Ethics Committee Address
Street address City Postal code Country
El mery , EL azzaritta alexandria 20122 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative pain score seven days 14 day 21 day 28 days after surgery. 6 months one year two years
Secondary Outcome Early postoperative complications Tell the first month
Secondary Outcome Recurrence Tell two years
Primary Outcome Patient satisfiaction At 14 day, 28 days 6 months One year Two years
Secondary Outcome Early postoperative complications Tell the first month
Secondary Outcome Recurrence Tell two years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria main university hospital El mery El azzaritta Alexandria 21212 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria University main university, El shatby Alexandria 21212 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University El mery El azzaritta Alexandria 21212 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Walid G Elshazly El mery El azzaritta Alexandria 21212 Egypt
Abd Elhamid Gazal El mery El azzaritta Alexandria 21212 Egypt
Khalid Madbouly El mery El azzaritta Alexandria 21212 Egypt
Maher El zeny El mery El azzaritta Alexandria 21212 Egypt
Ahmed Hussen El mery El azzaritta Alexandria 21212 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Elshazly wshazly@hotmail.com 0021221100756 el mery El azzaritta
City Postal code Country Position/Affiliation
Alexandria 21111 Egypt Associate professor of surgery
Role Name Email Phone Street address
Public Enquiries israa aly israa.aly@alexmed.edu.eg 0021287740750 el mery El azzaritta
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt ethical committee reponsible
Role Name Email Phone Street address
Scientific Enquiries Walid El bana wshazly@gmail.com 0021223493268 el mery El azzaritta
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt head of the surgical department
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