HaemorrhoidHeMuLaNCT07404774
Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty
An observational study of Haemorrhoid and Haemorrhoidal Bleeding, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoid, Haemorrhoidal Bleeding, Anorectal Surgeries
- What is being tested?
- Laser Haemorrhoidoplasty and Suture Mucopexy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2026to Jan 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Ippokrateio Hospital
Athens
George Theodoropoulos, +30 213 208 8000, georgetheocrs@live.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Laser Haemorrhoidoplasty and Suture Mucopexy
- Keywords
- haemorrhoid, laser, mucopexy, suture mucopexy, LHP, haemorrhoidoplasty
- Medical subject headings
- Hemorrhoids, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Haemorrhoidoplasty and Suture MucopexyProcedure or 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Defined as the number of days from surgery until the complete cessation of all opioid and non-opioid pain medications.
Measured: perioperatively
Primary Symptom Relief
Patient-reported cessation of bleeding and/or pain.
Measured: perioperatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: 3 months
Complications
Postoperative complications, specifically tracking urinary retention, bleeding, and anal stenosis (yes/no)
Measured: 12 months
Reoperation Rate
Need for secondary surgical intervention for recurrence or complications.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Theodoropoulos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404774
- Sponsor's protocol ID
- 100/22-12-2025
- Acronym
- HeMuLa
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study
- ClinicalTrials.gov ID
- NCT07404774
- Acronym / sponsor ID
- HeMuLa / 100/22-12-2025
- Keywords
- haemorrhoid, laser, mucopexy, suture mucopexy, LHP, haemorrhoidoplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Haemorrhoidoplasty and Suture MucopexyThe 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. | Procedure or surgery | – |
Primary outcome
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.
Primary Symptom Relief
Time frame: perioperatively
Patient-reported cessation of bleeding and/or pain.
4 secondary outcomes
Nyström Hemorrhoid Severity Score (HSS)
Time frame: 12 months
Morbidity
Time frame: 3 months
Complications
Time frame: 12 months
Reoperation Rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhoid and Haemorrhoidal Bleeding, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Theodoropoulos (+30 213 208.8000, georgetheocrs@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: perioperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.