A Comparative Study between the Therapeutic Results of Laser Hemorrhoidoplasty and Milligan-Morgan’s Open Surgical Hemorrhoidectomy in Patients with Hemorrhoids
Investigating and comparing the therapeutic result and possible side effects in the treatment of grade 3 and 4 hemorrhoids according to the two methods of laser hemorrhoidectomy and Milligan Morgan surgery.
Design
clinical trial with control group, with parallel groups, non-blinded, randomized on 100 patients. Calculator round function is used for randomization.
Settings and conduct
after selecting, patients will be under general anesthesia then one group of patients underwent a Milligan Morgan hemorrhoidectomy surgery and other group underwent laser hemerroidoplasty treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Ages over 18;
grade III, IV hemorrhoids;
non-respondent to medical treatment;
willing to participate in the study;
exclusion criteria:
patients with Fissure;
patients with Fistula;
patients with Coagulation disorder;
substance abuse;
patients with Irritable bowel disease;
patients who had hemorrhoid surgery treatment earlier
Intervention groups
In the control group, the procedure will be done as a Milligan Morgan classic method. in the intervention group, a 23 mm Proctoscope will be inserted into the anal canal . Once found, a 600micron optical fiber will subcutaneously be inserted into hemorrhoid through a 1 mm opening created with electrocautery in the anal vein (near the hemorrhoid base). Through optical fiber, then the laser device will be inserted into hemorrhoid and the coagulation occurs. Each shot has a power of 13 watts and a duration of 1.2 seconds. For each vessel, 5 shots will be fired 0.6 seconds apart. The other vessels will then be coagulated in a clockwise manner. The patient will be discharged 6-24 hours after surgery, depending on their physical condition.
Main outcome variables
Pain (0-10 VAS Score); Itching; Bleeding; Complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200909048672N2
Registration date:2023-01-03, 1401/10/13
Registration timing:registered_while_recruiting
Last update:2023-01-03, 1401/10/13
Update count:0
Registration date
2023-01-03, 1401/10/13
Registrant information
Name
Reza ٍٍEshraghi samani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0042
Email address
eshraghireza@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study between the Therapeutic Results of Laser Hemorrhoidoplasty and Milligan-Morgan’s Open Surgical Hemorrhoidectomy in Patients with Hemorrhoids
Public title
evaluation of the therapeutic effect of hemorrhidoplasty laser in hemorrhides
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged > 18 years
grade III, IV hemorrhoids
non-respondent to medical treatment
willing to participate in the study
Exclusion criteria:
patients with Fissure
patients with Fistula
patients with Coagulation disorder
substance abuse
Irritable bowel disease
patients who had hemorrhoid surgery treatment earlier
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
First, in the form of consecutive sampling, before the operation the patients go to the surgical clinic one by one , and then the surgeon checks the inclusion and exclusion criteria, and if it was appropriate, he randomly places patients in group A or B, so that ,The first person takes the last digit on the right side using the random function of calculator, and if the number is even, the person enters group A, and if the number is odd, he enters group B, and the second person is the opposite .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Since- Hezar jirib Street- Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.MUI.MED.REC.1400.500
Health conditions studied
1
Description of health condition studied
Anal Hemorrhoid Grade III
ICD-10 code
K64.2
ICD-10 code description
Third degree hemorrhoids
2
Description of health condition studied
Anal Hemorrhoid Grade IV
ICD-10 code
K64.3
ICD-10 code description
Fourth degree hemorrhoids
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 1st, 4th and 12th weeks after intervention
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Itching
Timepoint
Before intervention and 1st, 4th and 12th weeks after intervention
Method of measurement
asking the questions from patients
3
Description
Bleeding
Timepoint
Before intervention and 1st, 4th and 12th weeks after intervention
Method of measurement
asking the questions from patients
4
Description
Complications
Timepoint
1st, 4th and 12th weeks after intervention
Method of measurement
Visit by attending physician and asking the questions from patients
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Hemorrhoidectomy in Milligan Morgan procedure
Category
Treatment - Surgery
2
Description
Intervention group: Laser Hemorrhoidoplasty. To perform the procedure in the intervention group, a 23 mm Proctoscope will be inserted into the anal canal and a Doppler probe will search to find the upper rectal artery located 3 cm above the dentate line. Once found, a 600micron optical fiber will subcutaneously be inserted into hemorrhoid through a 1 mm opening created with electrocautery in the anal vein (near the hemorrhoid base). Through optical fiber, then the laser device will be inserted into hemorrhoid and the coagulation occurs. Each shot has a power of 13 watts and a duration of 1.2 seconds. For each vessel, 5 shots will be fired 0.6 seconds apart. The other vessels will then be coagulated in a clockwise manner. The patient will be discharged 6-24 hours after surgery, depending on their physical condition.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Reza Eshraghi
Street address
َAlzahra hospital-Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3822 0000
Email
surgery@med.mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Reza Eshraghi
Street address
Milad hospital-Bakhshi st-Janbazan st,
City
Isfahan
Province
Isfehan
Postal code
8179663467
Phone
+98 31 3513 0000
Fax
+98 31 3513 0000
Email
info@imsh.ir
Web page address
https://imsh.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Alzahra hospital-Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Eshraghi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Alzahra hospital-Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 300 2036
Email
eshraghireza@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Eshraghi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Alzahra hospital-Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 300 2036
Email
eshraghireza@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Eshraghi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Alzahra hospital-Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 300 2036
Email
eshraghireza@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data obtained from the study, including the data of the patients and statistical analysis maps and the results obtained after the official request from the competent authorities, will be provided to them.
When the data will become available and for how long
From the time of publication of the article for an unlimited period
To whom data/document is available
Official requests are answered from academic authorities and accredited scientific institutions and approved industrial centers.
Under which criteria data/document could be used
The data can be used to advance science in future articles or books, as well as to improve treatment methods with the help of new tools.
From where data/document is obtainable
Dr Reza Eshraghi
eshraghireza@med.mui.ac.ir
What processes are involved for a request to access data/document
Data will be announced after the approval of the main author of the article and the approval of the Research and Development Vice-Chancellor of Isfahan University of Medical Sciences