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

Haemorrhoids Clinical Trial

— RADIOLIGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170736
• Other study ID #: CHD22_0066
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: September 15, 2028

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Departemental Vendee
• Contact: Agnès DORION
• Phone: 251446380
• Email: agnes.dorion[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: September 15, 2028
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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.

Related Conditions & MeSH terms

• Haemorrhoids
• Hemorrhoids

Intervention

Procedure:
• Doppler-Guided Haemorrhoidal Artery Ligation
The principle consists of locating the signal emitted by the haemorrhoidal arteries using a Doppler probe. Once identified, the arteries are ligated in order to remove the arterial vascularization of the haemorrhoidal bundles. The treatment of the prolapse is reinforced by a folding of the mucosa of the lower rectum, called mucopexy.
• Radiofrequency ablation
The principle consists of inserting a metal probe under the mucosa of the anus, in contact with the haemorrhoidal bundles to be treated. A source of radiofrequency is then delivered through this probe in contact with the haemorrhoidal veins which will be sclerosed. The procedure is repeated for each haemorrhoidal bundle to be treated.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Amiens
France	Centre Hospitalier Universitaire	Angers
France	Centre Hospitalier Privé	Brest
France	Centre Hospitalier Départemental de Vendée	La Roche sur Yon
France	Hôpital de la Louvière	Lille
France	Clinique de la Sauvegarde	Lyon
France	Centre Hospitalier Universitaire	Nantes
France	Hôpital Saint Joseph	Paris
France	Institut Mutualiste Montsouris	Paris
France	Centre Hospitalier Interrégional	Poissy
France	Centre Hospitalier Universitaire	Rennes
France	hôpital d'Instruction des Armées	Saint-Mandé
France	Clinique de l'Estuaire	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate at one year post-operatively	The evaluation of failure rate will be based on the calculation of the HDSS score grouping the different symptoms (pain, discomfort, bleeding, soiling and prolapse). Failure rate will be defined by a score greater than or equal to the preoperative score or by a reoperation (surgical or instrumental) for relapse of the symptoms.	one year post-operatively