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IRCT20200909048672N2 IRCT 2023-01-03 Esfahan University of Medical Sciences evaluation of the therapeutic effect of hemorrhidoplasty laser in hemorrhides A Comparative Study between the Therapeutic Results of Laser Hemorrhoidoplasty and Milligan-Morgan’s Open Surgical Hemorrhoidectomy in Patients with Hemorrhoids 2022-09-23 anticipated 100 Complete https://irct.ir/trial/59095 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 . N/A Condition 1: Anal Hemorrhoid Grade III. Condition 2: Anal Hemorrhoid Grade IV. Intervention 1: Control group: Hemorrhoidectomy in Milligan Morgan procedure. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: From the time of publication of the article for an unlimited period To whom: Official requests are answered from academic authorities and accredited scientific institutions and approved industrial centers. Conditions: 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. Where to obtain: Dr Reza Eshraghi eshraghireza@med.mui.ac.ir How to obtain: 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 Comments:
public Reza Eshraghi
Alzahra hospital-Sofeh Blvd
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 300 2036 eshraghireza@med.mui.ac.ir Esfahan University of Medical Sciences scientific Reza Eshraghi
Alzahra hospital-Sofeh Blvd
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 300 2036 eshraghireza@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) aged > 18 years grade III, IV hemorrhoids non-respondent to medical treatment willing to participate in the study no limit no limit Both patients with Fissure patients with Fistula patients with Coagulation disorder substance abuse Irritable bowel disease patients who had hemorrhoid surgery treatment earlier K64.2 K64.3 Third degree hemorrhoids Fourth degree hemorrhoids Treatment - Surgery Treatment - Surgery Control group: Hemorrhoidectomy in Milligan Morgan procedure 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. Pain. Timepoint: Before intervention and 1st, 4th and 12th weeks after intervention. Method of measurement: Visual Analogue Scale questionnaire. Itching. Timepoint: Before intervention and 1st, 4th and 12th weeks after intervention. Method of measurement: asking the questions from patients. Bleeding. Timepoint: Before intervention and 1st, 4th and 12th weeks after intervention. Method of measurement: asking the questions from patients. Complications. Timepoint: 1st, 4th and 12th weeks after intervention. Method of measurement: Visit by attending physician and asking the questions from patients. Esfahan University of Medical Sciences Approved 2021-09-21 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Isfahan University of Medical Since- Hezar jirib Street- Isfahan Isfahan Isfehan Iran (Islamic Republic of)