M-C-LASER Trial: A randomized controlled trial comparing Chivates suture mucopexy combined with diode laser hemorrhoidoplasty versus sclerotherapy and Milligan-Morgan hemorrhoidectomy for symptomatic internal hemorrhoids.

This is a single center prospective randomized controlled trial at the Department of General Surgery IPGMER and SSKM Hospital Kolkata India. Adults aged 18 to 70 years with symptomatic internal hemorrhoids Grade II III or IV by Goligher classification will be enrolled after written informed consent.

A total of 160 participants will be randomized in a 1 to 1 ratio using grade stratified randomization with variable block sizes and allocation concealment using sequentially numbered opaque sealed envelopes. Surgeons will be unblinded. Participants outcome assessors and data analysts will be blinded to treatment allocation.

Participants will be allocated to either an experimental arm or a control arm based on hemorrhoid grade. In the experimental arm patients will undergo Chivate suture mucopexy combined with diode laser hemorrhoidoplasty. In the control arm Grade II patients will undergo sclerotherapy with 3 percent sodium tetradecyl sulfate and Grade III to IV patients will undergo Milligan Morgan open hemorrhoidectomy.

The primary outcome is postoperative pain assessed using the Visual Analog Scale at 6 24 48 and 72 hours after the procedure. Secondary outcomes include time to return to normal activities postoperative complications including bleeding infection and urinary retention requirement for opioid analgesics health related quality of life using the EQ 5D 5L recurrence at 6 and 12 months and bowel continence using the Wexner Incontinence Score. Follow up visits are planned at Day 30 Day 180 and Day 365.