Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty (HeMuLa)

February 8, 2026 updated by: George Theodoropoulos, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Ippokrateio Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: perioperatively
Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications.
perioperatively
Primary Symptom Relief
Time Frame: perioperatively
Patient-reported cessation of bleeding and/or pain.
perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nyström Hemorrhoid Severity Score (HSS)
Time Frame: 12 months
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.
12 months
Morbidity
Time Frame: 3 months
Postoperative morbidity (Clavien-Dindo classification), ranging from Grade I (minor, no intervention) to Grade V (death), at 30 days and 90 days.
3 months
Complications
Time Frame: 12 months
Postoperative complications, specifically tracking urinary retention, bleeding, and anal stenosis (yes/no)
12 months
Reoperation Rate
Time Frame: 12 months
Need for secondary surgical intervention for recurrence or complications.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100/22-12-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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