Overview
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
Eligibility
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
- Associated 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.