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IRCT20250908067174N3 IRCT 2025-10-06 Hamedan University of Medical Sciences Investigation of the results of laser and conventional hemorrhoid surgery Comparative study of outcomes of laser hemorrhoidoplasty and conventional hemorrhoidectomy in patients with grade II-III hemorrhoids: a randomized clinical trial 2025-10-23 anticipated 80 Complete https://irct.ir/trial/86244 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To allocate patients to treatment groups (A: conventional hemorrhoidectomy and B: laser hemorrhoidopexy), a block randomization method with a fixed block size of 4 will be used. This approach is adopted to ensure appropriate balance and predictability of allocation throughout the study; in each block of four, two patients are always assigned to group A and two patients to group B. The exact allocation sequence in each block (such as AABB or BABA) will be selected completely randomly from six possible possibilities, and this sequence generation process will be performed by a statistician independent of the study implementation team. To ensure allocation concealment and prevent bias, the randomly generated sequences will be placed inside opaque, sealed, and numbered envelopes. The opaqueness of the envelopes ensures that the internal content (letter A or B) is not visible from the outside, and their sealing prevents premature opening. The final group assignment process takes place in the operating room, just after the patient is put under anesthesia. At this point, the surgical team opens the next sealed envelope, and the letter inside the envelope determines the type of surgical intervention (A or B). N/A Hemorrhoids. Intervention 1: Intervention group: Laser hemorrhoid surgery in lithotomy position with general anesthesia. Intervention 2: Intervention group: Hemorrhoid surgery performed using the conventional method (Milligan-Morgan-Ferguson) in the lithotomy position under general anesthesia. Yes - There is a plan to make this available What will be shared: The information of all the participants without individual information will be published in most of the tables as a general conclusion. When: After the end of the patient admission and the final analysis of the data To whom: The general public Conditions: In order to increase people's awareness in the field of hemorrhoid surgery methods and to improve the clinical skills of patients in the field of choosing a more effective surgical method according to the lifestyle and clinical condition of patients. Where to obtain: Valid databases for publishing articles How to obtain: Refer to the desired database and use keywords to access the article Comments:
public Rohollah Taghavi
Valiasr Hospital., Jomhuri Blvd.
Qom Iran (Islamic Republic of) 3716764811 +98 25 3212 2200 fateme1380samiee@gmail.com Hamedan University of Medical Sciences scientific Rohollah Taghavi
Valiasr Hospital., Jomhuri Blvd.
Qom Iran (Islamic Republic of) 3716764811 +98 25 3212 2200 fateme1380samiee@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age Patients with grade 2 and 3 hemorrhoids according to the Golliger classification who have not responded to medical treatments 18 years no limit Both Patients with grade four hemorrhoids Pregnant women Women who are menstruating at the time of surgery Patients with other anal diseases, including anal fistulas and abscesses, rectal cancers, and inflammatory bowel diseases that affect the rectum (Crohn's disease and ulcerative colitis) Thrombosed hemorrhoids Patients with recurrent hemorrhoids K64 Hemorrhoids and perianal venous thrombosis Treatment - Surgery Treatment - Surgery Intervention group: Laser hemorrhoid surgery in lithotomy position with general anesthesia. Intervention group: Hemorrhoid surgery performed using the conventional method (Milligan-Morgan-Ferguson) in the lithotomy position under general anesthesia. Post operative pain. Timepoint: 24 hours, 3 days, 7 days, 14 days, and 1 month after surgery. Method of measurement: Visual analog scale. Symptoms of hemorrhoids (pain, bleeding, itching, dirt, and prolapse). Timepoint: Before surgery and two weeks, one month, three months, six months after surgery. Method of measurement: Rorvik scale. Hamedan University of Medical Sciences Approved 2025-09-06 Ethics committee of Hamadan University of Medical Sciences 5th Floor, Central Headquarters of University of Medical Sciences, Research Square, Shahid Fahmideh Blvd, Hamadan Hamadan Hamadan Iran (Islamic Republic of)