Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
Recruiting now · Not applicable
Conditions studied: Haemorrhoids, Internal Haemorrhoids, Grade II/III Haemorrhoids
In brief
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
Key facts
- Study ID
- NCT06170736
- Run by
- Centre Hospitalier Departemental Vendee
- People needed
- 168
- Starts
- 2024-02-21
- Expected to finish
- 2030-09-15
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Clinique de l'Estuaire — Saint-Nazaire, France (enrolling)
- Centre Hospitalier Universitaire — Angers, France (enrolling)
- Maison de Santé Bagatelle — Bordeaux, France (enrolling)
- Centre Hospitalier Privé — Brest, France (enrolling)
- Clinique du val d'Ouest — Écully, France (enrolling)
- Centre Hospitalier Départemental de Vendée — La Roche-sur-Yon, France (enrolling)
- Hôpital de la Louvière — Lille, France (enrolling)
- CHU Limoges — Limoges, France (enrolling)
- Clinique de la Sauvegarde — Lyon, France (enrolling)
- Centre Hospitalier Universitaire — Nantes, France (enrolling)
- Clinique Jules Verne — Nantes, France (enrolling)
- Hôpital Saint Joseph — Paris, France (enrolling)
- Institut Mutualiste Montsouris — Paris, France (enrolling)
- Centre Hospitalier Interrégional — Poissy, France (enrolling)
- Centre Hospitalier Universitaire — Rennes, France (enrolling)
- Centre Hospitalier Universitaire — Amiens, France (enrolling)
- hôpital d'Instruction des Armées — Saint-Mandé, France (enrolling)
- Cabinet de Proctologie — Saint-Herblain, France
Full record on ClinicalTrials.gov
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