Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain

NCT07846904 | Not Yet Recruiting

• 1 other identifier: 48.ERC/FMU/2024-25-23
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemorrhoid

Keywords

Hemorrhoids; Internal hemorrhoids; Laser hemorrhoidoplasty; Milligan-Morgan hemorrhoidectomy; Postoperative pain; Visual Analogue Scale; Hemorrhoidectomy; Rescue analgesia; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after surgery (postoperative day 1), before administration of the scheduled postoperative analgesic

Study Arms (2)

Open Milligan-Morgan Hemorrhoidectomy

ACTIVE COMPARATOR

Participants allocated to this group will undergo open Milligan-Morgan hemorrhoidectomy for symptomatic grade II, III, or IV internal hemorrhoids.

Procedure: Open Milligan-Morgan Hemorrhoidectomy

Laser Hemorrhoidoplasty

EXPERIMENTAL

Participants allocated to this group will undergo laser hemorrhoidoplasty (LHP) for symptomatic grade II, III, or IV internal hemorrhoids.

Procedure: Laser Hemorrhoidoplasty

Interventions

Open Milligan-Morgan Hemorrhoidectomy PROCEDURE

Participants 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.

Open Milligan-Morgan Hemorrhoidectomy

Laser Hemorrhoidoplasty PROCEDURE

Participants 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.

Laser Hemorrhoidoplasty

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients fit for elective surgery under anesthesia, classified as ASA physical status I or II.

You may not qualify if:

• Patients with associated anorectal pathologies, including anal fissure, fistula-in-ano, inflammatory bowel disease, or anorectal malignancy.
• Patients with bleeding diathesis or deranged coagulation profiles, including prolonged PT, APTT, or INR.
• Patients with chronic liver disease or portal hypertension. Patients classified as ASA physical status III or IV. Immunocompromised patients, including those with confirmed HIV infection.

Sponsors & Collaborators

• Allied Hospital Faisalabad: lead

Related Publications (4)

• Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.

  PMID: 38294832 BACKGROUND

• Wee IJY, Koo CH, Seow-En I, Ng YYR, Lin W, Tan EJK. Laser hemorrhoidoplasty versus conventional hemorrhoidectomy for grade II/III hemorrhoids: a systematic review and meta-analysis. Ann Coloproctol. 2023 Feb;39(1):3-10. doi: 10.3393/ac.2022.00598.0085. Epub 2023 Jan 3.

  PMID: 36593573 BACKGROUND

• Tan VZZ, Peck EW, Sivarajah SS, Tan WJ, Ho LML, Ng JL, Chong C, Aw D, Mainza F, Foo FJ, Koh FH. Systematic review and meta-analysis of postoperative pain and symptoms control following laser haemorrhoidoplasty versus Milligan-Morgan haemorrhoidectomy for symptomatic haemorrhoids: a new standard. Int J Colorectal Dis. 2022 Aug;37(8):1759-1771. doi: 10.1007/s00384-022-04225-4. Epub 2022 Jul 29.

  PMID: 35906356 BACKGROUND

• Naderan M, Shoar S, Nazari M, Elsayed A, Mahmoodzadeh H, Khorgami Z. A Randomized Controlled Trial Comparing Laser Intra-Hemorrhoidal Coagulation and Milligan-Morgan Hemorrhoidectomy. J Invest Surg. 2017 Oct;30(5):325-331. doi: 10.1080/08941939.2016.1248304. Epub 2016 Nov 2.

  PMID: 27806213 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Muhammad Faisal Bilal Lodhi, MBBS, FCPS General Surgery

  Allied Hospital Faisalabad

  STUDY CHAIR

Central Study Contacts

Abdul Basit, MBBS

CONTACT

+92 301 6705830; abdulbasit.ab361@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate resident

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share