NCT07404774

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jan 2029

Study Start

First participant enrolled

January 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 29, 2026

Last Update Submit

February 8, 2026

Conditions

HaemorrhoidHaemorrhoidal BleedingAnorectal SurgeriesAnorectal Diseases

Keywords

haemorrhoidlasermucopexysuture mucopexyLHPhaemorrhoidoplasty

Outcome Measures

Primary Outcomes (2)

  • Duration of analgesia

    Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications.

    perioperatively

  • Primary Symptom Relief

    Patient-reported cessation of bleeding and/or pain.

    perioperatively

Secondary Outcomes (4)

  • Nyström Hemorrhoid Severity Score (HSS)

    12 months

  • Morbidity

    3 months

  • Complications

    12 months

  • Reoperation Rate

    12 months

Interventions

Laser Haemorrhoidoplasty and Suture MucopexyPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ippokrateio Hospital

Athens, Greece

RECRUITING

MeSH Terms

Conditions

HemorrhoidsRectal Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

George Theodoropoulos

CONTACT

+30 213 208.8000georgetheocrs@live.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 11, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

GR(1)