Comparative study of outcomes of laser hemorrhoidoplasty and conventional hemorrhoidectomy in patients with grade II-III hemorrhoids: a randomized clinical trial

Examining and comparing the intraoperative and postoperative results of two types of hemorrhoidectomy surgery (conventional hemorrhoidectomy and laser hemorrhoidoplasty)

Randomized, parallel-group, unblinded clinical trial on 80 patients

All patients with hemorrhoids referred to Valiasr Hospital in Qom are randomly assigned to one of the intervention groups: conventional hemorrhoidectomy or laser hemorrhoidoplasty.

All patients over 18 years of age with hemorrhoids were included, and patients with a history of previous anal surgery were excluded.

In laser hemorrhoidectomy surgery, a 2-3 mm skin incision is made at the anal edge of each pile and the laser fiber is inserted through the incision to the root of the internal hemorrhoid above the dentate line and is positioned in accordance with the laser fiber guide light. The laser device energy is set equal for each subgroup. The duration of each pulse for each group will be 3 seconds. This process is also performed for all other visible hemorrhoids of the patient. In the traditional surgical group that undergoes open hemorrhoidectomy (Milligan-Morgan). The hemorrhoid is grasped using Alice forceps or a hemostat and its removal from the internal anal sphincter is performed using monopolar diathermy until it reaches the base. Then the hemorrhoid base will be ligated and coagulated and a dressing will be applied. In the traditional surgical group, who undergo closed hemorrhoidectomy (Ferguson). The hemorrhoids are removed from the anorectal junction with a cautery, the base of the hemorrhoid base is transfixed, and the surgical site is closed with sutures.

Intraoperative and Postoperative Pain and Bleeding

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).

The information of all the participants without individual information will be published in most of the tables as a general conclusion.

After the end of the patient admission and the final analysis of the data

The general public

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.

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