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

Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial

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

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.