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 range18 Years – 80 Years

SexALL

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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.

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