Clinical trial NCT06170736: Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Haemorrhoids
Internal Haemorrhoids
Grade II/III Haemorrhoids
Keywords: Haemorrhoids
Radiofrequency
Doppler-guided haemorrhoidal artery ligation
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Failure rate at one year post-operatively
timeFrame: one year post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Brest
country: France
facility: Centre Hospitalier Privé
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
city: Lille
country: France
facility: Hôpital de la Louvière
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Poissy
country: France
facility: Centre Hospitalier Interrégional
city: Rennes
country: France
facility: Centre Hospitalier Universitaire
city: Saint-Mandé
country: France
facility: hôpital d'Instruction des Armées
city: Saint-Nazaire
country: France
facility: Clinique de l'Estuaire
Study officials:
affiliation: Centre Hospitalier Departemental Vendée
name: Marc-Henri JEAN, Dr
role: PRINCIPAL_INVESTIGATOR
References: