An observational study in Haemorrhoid, Haemorrhoidal Bleeding and Anorectal Surgeries, sponsored by National and Kapodistrian University of Athens. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by National and Kapodistrian University of Athens · Observational
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 100 is below the median of 151 across 49 observational studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
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Participants will be drawn from the outpatient and surgical patient base of the Department of Colorectal Surgery at Ippokrateio University Hospital. All individuals presenting with symptomatic hemorrhoidal disease of Goligher Grades II-IV, regardless of prior non-excisional treatment, are eligible for invitation to the study. This cohort represents a real-world clinical population of patients undergoing minimally invasive hemorrhoid management within a single, high-volume colorectal surgery practice.
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Exclusion Criteria:
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.
Duration of analgesia
Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications.
Time frame: perioperatively
Primary Symptom Relief
Patient-reported cessation of bleeding and/or pain.
Time frame: perioperatively
Nyström Hemorrhoid Severity Score (HSS)
5 items (pain, itching, bleeding, prolapse, soiling) scored 0-3 (higher score indicates worse symptoms), assessed at preoperative baseline, 6 weeks, 6 months, and 12 months.
Time frame: 12 months
Morbidity
Postoperative morbidity (Clavien-Dindo classification), ranging from Grade I (minor, no intervention) to Grade V (death), at 30 days and 90 days.
Time frame: 3 months
Complications
Postoperative complications, specifically tracking urinary retention, bleeding, and anal stenosis (yes/no)
Time frame: 12 months
Reoperation Rate
Need for secondary surgical intervention for recurrence or complications.
Time frame: 12 months
Plan to share: Undecided
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