About this trial
Hemorrhoidal disease is a common condition that can cause symptoms such as rectal bleeding and protrusion of tissue through the anal canal. For patients with symptomatic grade II, III, or IV internal hemorrhoids who require surgery, different surgical techniques are available.
This randomized controlled trial will compare postoperative pain between two surgical treatments for hemorrhoids: laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The study will include adult patients aged 20-50 years with symptomatic grade II, III, or IV internal hemorrhoids who are suitable for elective surgery.
A total of 68 participants will be enrolled and randomly allocated in a 1:1 ratio to either open Milligan-Morgan hemorrhoidectomy or laser hemorrhoidoplasty. Postoperative pain will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The primary outcome will be the VAS pain score 24 hours after surgery. Pain will also be assessed 72 hours after surgery as a secondary outcome.
The study will also record the need for rescue analgesia and the total amount of rescue tramadol administered during the first 72 hours after surgery. Relevant postoperative complications will also be monitored.
The purpose of the study is to determine whether there is a difference in postoperative pain between laser hemorrhoidoplasty and open Milligan-Morgan hemorrhoidectomy. The findings may provide locally relevant information regarding postoperative pain and early recovery following these two surgical approaches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Open Milligan-Morgan Hemorrhoidectomy
Procedure/SurgeryParticipants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for the treatment of symptomatic grade II, III, or IV internal hemorrhoids. The procedure will be performed as per the standard surgical practice of the institution.
Laser Hemorrhoidoplasty
Procedure/SurgeryParticipants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for the treatment of symptomatic grade II, III, or IV internal hemorrhoids. Laser energy will be applied using a submucosal approach to produce thermal coagulation followed by shrinkage of the hemorrhoidal tissue.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain score
Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Locations
Sponsors and contacts
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