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NCT Number: NCT06170736

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

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

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Key information

Conditions

Haemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Grade II/III Haemorrhoids Hemorrhoids Internal Haemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doppler-Guided Haemorrhoidal Artery Ligation

Procedure

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

Procedure

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.

Primary outcomes

Failure rate at one year post-operatively

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnès DORION

CONTACT

[email protected]

251446380 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

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

Acronym: RADIOLIGA

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2030
First posted: Dec 14, 2023
Registry last updated: Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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