NCT07404774

Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty

Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective cohort study evaluates whether combining "suture mucopexy" (a simple stitch-based lift of prolapsed tissue) with Laser Hemorrhoidoplasty (LHP) can effectively relieve pain, bleeding and prolapse in adults with moderate-to-severe hemorrhoids (Grades II-IV). Participants will undergo the combined, non-Doppler-guided procedure and be followed for one year. The primary question is how long patients need post-operative pain medication and if they first experience complete symptom relief; secondary questions examine quality-of-life, safety (bleeding, urinary retention, stenosis) and the rate of hemorrhoid recurrence/re-operation.

Detailed description

Laser Hemorrhoidoplasty (LHP) offers a minimally invasive option for symptomatic hemorrhoids, yet in advanced disease (Goligher III/IV) recurrence rates of 20-35 % have been reported because residual mucosal prolapse persists. Adding a suture-based mucopexy (SM) eliminates the prolapse and ligates feeding vessels without the need for Doppler guidance, thereby potentially reducing recurrence while preserving the low-pain advantage of LHP. Preliminary experience with 50 patients at this centre demonstrated feasibility, low early complication rates, and promising symptom control, justifying a formal prospective evaluation. The present study is a single-center, prospective observational cohort enrolling consecutive eligible adults over a 24-month accrual period. All participants receive the same combined LHP + SM technique; no comparator arm is planned. Follow-up visits occur at postoperative week 6, month 6 and month 12.

Conditions

• Haemorrhoid
• Haemorrhoidal Bleeding
• Anorectal Surgeries
• Anorectal Diseases

Interventions

Type	Name	Description
PROCEDURE	Laser Haemorrhoidoplasty and Suture Mucopexy	The procedure combines laser ablation (LHP) with suture mucopexy (SM) performed without Doppler guidance. Suture Mucopexy (SM): Using a slotted proctoscope, continuous suture mucopexy (plication) is performed at standardized anatomical positions (typically 4, 7, 11 o'clock) to lift the prolapse and ligate feeding vessels. Sutures are placed approximately 2-4 cm proximal to the dentate line. Laser Hemorrhoidoplasty (LHP): A 1470nm diode laser fiber is inserted into the hemorrhoidal cushion. Energy is delivered (approx. 250-350 J per pile) to induce shrinkage and fibrosis.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Greece