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NCT Number: NCT07404774

Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty

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.

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Key information

Conditions

Haemorrhoid Anorectal Diseases Anorectal Surgeries Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Haemorrhoidal Bleeding Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Laser Haemorrhoidoplasty and Suture Mucopexy

Procedure

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.

Primary outcomes

  1. 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.

  2. Primary Symptom Relief

    Time frame: perioperatively

    Patient-reported cessation of bleeding and/or pain.

Secondary outcomes

  1. 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.

  2. 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. Complications

    Time frame: 12 months

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

  4. Reoperation Rate

    Time frame: 12 months

    Need for secondary surgical intervention for recurrence or complications.

Study contacts

Contact information is provided by the study sponsor or research team.

George Theodoropoulos

CONTACT

[email protected]

+30 213 208.8000

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Acronym: HeMuLa

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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