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

Centre Hospitalier Departemental Vendee

Status: Enrolling

Conditions: Haemorrhoids; Grade II/III Haemorrhoids; Internal Haemorrhoids

Treatments: Procedure: Doppler-Guided Haemorrhoidal Artery Ligation; Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06170736

CHD22_0066

Details and patient eligibility

About

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

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Doppler-Guided Haemorrhoidal Artery Ligation

Active Comparator group

Description:

Patients will be treated by DGHAL procedure.

Treatment:

Procedure: Doppler-Guided Haemorrhoidal Artery Ligation

Radiofrequency Ablation

Experimental group

Description:

Patients will be treated by radiofrequency ablation.

Treatment:

Procedure: Radiofrequency ablation