RecruitingNot Applicable

Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease

France168 participantsStarted 2024-02-21

Plain-language summary

Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years. Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate \< 5%. To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids. The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Major patient, * With symptomatic Grade II or III haemorrhoidal disease, * Requiring surgical management, * Patient able to understand the protocol and having given written informed consent to participate in the study, * Patient affiliated to the social security system or entitled to it. Exclusion Criteria: * Hemostasis disorders * Active external haemorrhoidal disease (thrombosis) * History of surgical procedure for treatment of haemorrhoids (instrumental treatment is not a contra-indication) * Associated proctological pathology (anal fissure, chronic suppuration, external rectal prolapse) * History of colorectal cancer * History of inflammatory bowel disease * History of rectal resection * Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device * Patient who is pregnant, breastfeeding or able to procreate without effective contraception\* at the time of inclusion * Patient under guardianship, curators or deprived of liberty. * Patient under court protection. * oral contraceptive (pill), monthly vaginal ring, weekly transdermal patch, subcutaneous implant, intrauterine devices (IUD), or sterilisation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Failure rate at one year post-operatively

Timeframe: one year post-operatively

Trial details

NCT IDNCT06170736

SponsorCentre Hospitalier Departemental Vendee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-15

Contact for this trial

Agnès DORION

251446380 agnes.dorion@ght85.fr

View on ClinicalTrials.gov More Haemorrhoids trials