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.: PACTR202508807010193 Date of Registration: 05/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between Laser Hemorroidoplasty and Conventional Hemorroidectomy
Official scientific title Comparative Study between Laser Hemorroidoplasty and Conventional Hemorroidectomy
Brief summary describing the background and objectives of the trial Laser Hemorrhoidoplasty (LHP) is a minimally invasive, painless laser procedure for treating hemorrhoids. Although LHP is claimed to have questionable benefits compared to conventional methods, it is still not gaining popularity as a routine practice in many countries like Egypt with no research done over Egyptian population. The aim of the study was to compare LHP versus Milligan-Morgan Hemorrhoidectomy in patients with grade III and grade IV hemorrhoids regarding operative time, intra operative bleeding, post-operative pain, post-operative bleeding, presence of discharge, anal stenosis, incontinence and recurrence.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2024
Actual trial start date 01/01/2024
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Milligan Morgan Hemorrhoidectomy 30 minutes V-shaped incision by the scalpel in the skin was made around the base of the hemorrhoid, dissection had been performed in the submucous space cranially to the pedicle to strip the entire hemorrhoid from its bed, hemorrhoidal pedicle was ligated with vicryl 0 and the distal part was excised, other hemorrhoids were similarly treated, leaving a skin bridge in between to avoid stenosis and the wound was left open and a hemostatic gauze with lignocaine cream was left in the anal canal 50 Active-Treatment of Control Group
Experimental Group Laser Hemorroidoplasty 30 minutes A skin microincision of 2 mm was made at the mucocutanous junction at the base of each hemorrhoidal node by diathermy tip or laser probe, the probe (1.85 mm of diameter) was driven through the incision in the submucosal tissue until reaching the area underneath the distal rectal mucosa, then, 10–12 effective pulses ,8 W per 3 s each, of approximately 24 Joule using a 1470-nm diode laser generator were fired. First, fire was applied to the tip of each pedicle, then two fires applied 0.5 cm distally then three fires applied to the base of the pedicle, ice packs were applied to the anal wounds for about two minutes to reduce postoperative edema and wounds were left open and sterile gauze with lignocaine cream were applied with no need for further hemostasis 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with grade III, IV hemorrhoids according to Goligher’s classification, and failure of conservative treatment unfit for surgery history of any previous anal surgery (fistula, abscess, rectal carcinoma, inflammatory bowel disease) patient with any grade of incontinence and a deficient perineum. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 09/05/2023 the research ethics committee at Faculty of Medicine Al Azhar university
Ethics Committee Address
Street address City Postal code Country
King faisal St Assuit 71523 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain, bleeding, and fecal and gas incontinence 1 week, 3 months and 6 months after the end of the surgical procedure
Secondary Outcome presence of recurrence of hemorrhoids 6 months after the end of surgical procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar university Hospital King faisal St Assuit Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar university king faisal st Assuit Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university king faisal St Assuit Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Amer goodsurgeon108@gmail.com 00201229183866 dakalt
City Postal code Country Position/Affiliation
Kafrelshikh Egypt assistant lecturer of general surgery Al Azhar university
Role Name Email Phone Street address
Public Enquiries Saad Ali saadmohaly1985@gmail.com 00201229183866 Diarb negm city
City Postal code Country Position/Affiliation
El sharkea governorat Egypt lecture of general surgery Al Azhar university
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Aboamra dr.maboamra@Azhar.edu.eg 00201001222981 Farshout
City Postal code Country Position/Affiliation
Qena Egypt professor of general surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication. 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 05/08/2025 PACTR Admin 01 Jan 2024
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 05/08/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)