Suture mucopexy plus laser treatment for moderate-to-severe hemorrhoids
Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study
This study will test whether adding a stitch-based mucosal lift to laser hemorrhoidoplasty reduces pain, bleeding, and prolapse in adults with moderate-to-severe (Grade II–IV) hemorrhoids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT07404774 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational cohort in which all enrolled adults with Goligher Grade II–IV hemorrhoids receive a combined suture mucopexy and non‑Doppler laser hemorrhoidoplasty. The combined procedure aims to remove mucosal prolapse and ligate feeding vessels while preserving the low-pain recovery profile of laser treatment. Participants are followed at 6 weeks, 6 months, and 12 months to record pain medication use, time to complete symptom relief, quality of life, safety events (bleeding, urinary retention, stenosis), and recurrence or re-operation. The approach is supported by preliminary feasibility data from 50 patients at the same center but is being evaluated formally in this prospective cohort.
Who should consider this trial
Good fit: Adults over 18 with symptomatic hemorrhoidal disease (Goligher Grades II–IV), including those with prior non-stapled procedures, who can attend the Athens center are ideal candidates.
Not a fit: Patients with acutely thrombosed hemorrhoids, concurrent anal fistula or abscess requiring separate surgery, active rectal IBD, or prior stapled haemorrhoidopexy are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the combined technique could give faster symptom relief with fewer recurrences and fewer repeat operations while maintaining low post‑operative pain.
How similar studies have performed: Laser hemorrhoidoplasty is known for low‑pain recovery but higher recurrence in advanced prolapse, and single-center preliminary data (50 patients) suggest the mucopexy+LHP combination is feasible with low early complications, though larger prospective evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (\>18 years). * Symptomatic Hemorrhoidal Disease (Goligher Grades II, III, IV). * Patients with or without recurrent disease after prior procedures (e.g., RBL, infrared coagulation, Milligan-Morgan, etc). Exclusion Criteria: * Acutely thrombosed hemorrhoids. * Concomitant anal fistula or abscess requiring separate surgical management. * IBD (Crohn's/Ulcerative Colitis) with active rectal involvement. * Previous Stapled Haemorrhoidopexy (SH/Longo).
Where this trial is running
Athens
- Ippokrateio Hospital — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: George Theodoropoulos
- Email: georgetheocrs@live.com
- Phone: +30 213 208.8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.