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.: PACTR201511001337209 Date of Approval: 03/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sucralfate Ointment Reduces Pain & Improves Healing Following Haemorrhoidectomy: A Prospective, Randomized, Controlled & Double- Blinded Study
Official scientific title Sucralfate Ointment Reduces Pain & Improves Healing Following Haemorrhoidectomy: A Prospective, Randomized, Controlled & Double- Blinded Study
Brief summary describing the background and objectives of the trial It is clinically observed that post-haemorroidectomy pain is the most feared symptom by the patient, often leading to avoiding surgery altogether. Opioids and non-steroidal anti-inflammatory drugs are used to control post haemorrhoidectomy pain, but they have short duration of action, well-known side effects and may be expensive. These factors justify the need to search for new treatments to decrease post haemorrhoidectomy pain.Aim of the study: to evaluate the effect of using 10% sucralfate ointment on post-haemorrhoidectomy pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,post-haemorrhoidectomy pain.
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/07/2014
Actual trial start date 07/07/2014
Anticipated date of last follow up 02/11/2015
Actual Last follow-up date 02/11/2015
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 90
Recruitment status Completed
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 closed envelope at the end of the study Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group topical sucralfate ointment 1 gm of 10 % sucralfate in petrolatum tds for 28 days local application 45
Control Group topical ointment of plain petrolatum 1 gm tds for 28 days local application 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients indicated for haemorroidectomy for 3rd and 4th degree haemorrhoids and surgery done by the standard Milligan-Morgan technique of open hemorrhoidectomy Exclusion criteria included patients with associated anal or rectal pathologies (e.g. fistulae, prolapse, abscess.¿), patients younger than 21 years & older than 60 years, patients who did not complete the needed study protocol. All surgeries were carried out by the same surgeon and following the same anaethesia protocol, in order to abolish any inter-personal variation. 21 Year(s) 60 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 01/07/2014 ethics committee faculty of medicine
Ethics Committee Address
Street address City Postal code Country
gamal abdelnaser Shibin Alkom 32111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessment of post operative pain days 1, 7 and 14
Secondary Outcome assessment of wound healing day 28 post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospital gamal abdelnaser street shibeen alkom 32111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia faculty of medicine gamal abdelnaser street Shibin Alkom 32111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia faculty of medicine gamal abdelnaser street Shibin Alkom 32111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ayman A Albatanony gamal abdelnaser street Shibin Alkom 32111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Albatanony aymanalbatanony@hotmail.com 201024341333 Gamal Abdelnaser street
City Postal code Country Position/Affiliation
Shibin Alkom 32111 Egypt assistant professor of general surgery
Role Name Email Phone Street address
Public Enquiries Ayman Albatanony aymanalbatanony@hotmail.com 201024341333 Gamal Abdelnaser street
City Postal code Country Position/Affiliation
Shibin Alkom 32111 Egypt assistant professor of general surgery
Role Name Email Phone Street address
Scientific Enquiries Ayman Albatanony aymanalbatanony@hotmail.com 201024341333 Gamal Abdelnaser street
City Postal code Country Position/Affiliation
Shibin Alkom 32111 Egypt assistant professor of general surgery
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