Health TrialsbyHealthPanel

Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty

ConditionsHaemorrhoidHaemorrhoidal BleedingAnorectal SurgeriesAnorectal Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Laser Haemorrhoidoplasty and Suture Mucopexy

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

Primary Symptom Relief

Patient-reported cessation of bleeding and/or pain.

Time frame
perioperatively

Secondary outcomes

1

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
2

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
3

Complications

Postoperative complications, specifically tracking urinary retention, bleeding, and anal stenosis (yes/no)

Time frame
12 months
4

Reoperation Rate

Need for secondary surgical intervention for recurrence or complications.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National and Kapodistrian University of Athens

Lead sponsor

Source ClinicalTrials.gov
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