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.: PACTR202007500437121 Date of Approval: 01/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of topical application of Moist Exposed Burn Ointment (MEBO) on post-operative healing after hemorrhoidectomy
Official scientific title Impact of post-hemorrhoidectomy topical application of Moist Exposed Burn Ointment (MEBO) on postoperative pain and quality of life: a prospective randomized controlled trial
Brief summary describing the background and objectives of the trial Post-operative pain is the most distressing concern for the patient after hemorrhoidectomy. Many topical drugs were used for alleviation of post-hemorrhoidectomy pain including Botulinum toxin, Calcium Channel Blockers, GlycerylTrinitrate (GTN), local anesthetics, Metronidazole, Opioids, and Sucralfate. Most of these topical drugs act by local anesthetic effect or relaxing the internal sphincter and hence decrease pain and circulation to the wound which may also improve healing. However loss of anoderm and delayed wound healing due to infection and edema may also participate in increasing post-operative pain, delay discharge from the hospital, and affect the postoperative quality of life. Moist Exposed Wound Ointment (MEBO) (Julphar Gulf Pharmaceutical Industries, UAE) is the basis of MEBT (Moist Exposed Burn Therapy). It has been popularized two decades ago by Xu Rongxiang from the Beijing Chinese Burn Center. It offers the advantages of a moist environment for wound healing in addition to those of the open treatment technique avoiding cumbersome, bulky, and expensive dressings. Chinese literature has demonstrated that the ointment markedly reduces evaporation from the wound surface. It has an inhibitory effect on smooth muscle cells, which is dose-related and has no evident effect on the humoral and cellular immune defense mechanisms (16, 17). The aim of this work is to study the impact of post-hemorrhoidectomy topical application of MEBO on wound healing, post-operative pain, and quality of life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/07/2020
Actual trial start date
Anticipated date of last follow up 15/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 348
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 randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group hemorrhoidectomy with application of MEBO ointment on the wound of the hemorrhoidectomy topical application twice daily for 6 weeks Moist Exposed Wound Ointment (MEBO) (Julphar Gulf Pharmaceutical Industries, UAE) 174
Control Group Hemorrhoidectomy with no application of MEBO no application No application Hemorrhoidectomy with no application of MEBO 174 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients above 18 years with grade III and IV hemorrhoids. Patients who have concomitant ano-rectal disorder, recurrent hemorrhoids or complicated hemorhhoids will be excluded from the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 05/06/2020 The Research Ethics Committee at King Khalid University
Ethics Committee Address
Street address City Postal code Country
Guraiger, Abha 62529, Saudi Arabia Abha 62529 Saudi Arabia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain measured by Modified Visual Analog Scale after 2, 4 and 8 weeks by the patient and recorded by the surgeon during follow-up visits in outpatient clinic.
Primary Outcome Quality of life using the Cleveland Global Quality of life score (CGQl) after 4 and 8 weeks to be filled by the patients and recorded by the surgeon during follow-up visits in outpatient clinic
Primary Outcome Healing time defined as complete healing of the external wound to be reported by the surgeon during follow-up visits in outpatient clinic.
Secondary Outcome Detection of early and late postoperative complications in the two groups by the surgeon during follow-up visits in outpatient clinic after 2, 4 and 8 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospitals 1 kolleyet al teb Street, Azareetah, Alexandria Egypt Alexandria 21526 Egypt
Aseer Central Hospital Al Rabwah, Abha 62523, Arabia Saudita Arabia Abha 62523 Saudi Arabia
Abha Private International Hospital Imam Mohammed ben Saud, Al Sadd District, Abha 62521, Saudi Arabia Abha 62521 Saudi Arabia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Walid Mohamed Abd El Maksoud King khalid university, faculty of Medicine, surgery department PO 641 Abha 61421 Saudi Arabia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Main University Hospital 1 kolleyet al teb Street, Azareeta, Alexandria, Egypt Alexandria 21526 Egypt Hospital
Primary Sponsor Aceer Central Hospital Al Rabwah, Abha 62523 Abha 62523 Saudi Arabia Hospital
COLLABORATORS
Name Street address City Postal code Country
There are no collaborators included in the study none none 00000 Saudi Arabia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Abd El Maksoud wabdulmksoud@kku.edu.sa 00966543128555 Guraiger, Abha 62529
City Postal code Country Position/Affiliation
Abha 61421 Saudi Arabia Associate professor of surgery
Role Name Email Phone Street address
Public Enquiries Walid Abd EL Maksoud wabdulmksoud@kku.edu.sa 00966543128555 Guraiger, Abha 62529
City Postal code Country Position/Affiliation
Abha 61421 Saudi Arabia Associate professor of surgery
Role Name Email Phone Street address
Scientific Enquiries Walid Abd El Maksoud wabdulmksoud@kku.edu.sa 00966543128555 Guraiger, Abha 62529
City Postal code Country Position/Affiliation
Abha 61421 Saudi Arabia Associate professor of surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary results within the trial registration record. This will be done within 12 months of the study completion date. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12 months of data completion. patients IDs will be concealed, otherwise, access to data will be open.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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