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

Официальное название

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

Обзор

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

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Failure rate at one year post-operatively [Срок оценки: one year post-operatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 18 центров

• Centre Hospitalier Universitaire — Amiens
• Centre Hospitalier Universitaire — Angers
• Maison de Santé Bagatelle — Bordeaux
• Centre Hospitalier Privé — Brest
• Clinique du val d'Ouest — Écully
• Centre Hospitalier Départemental de Vendée — La Roche-sur-Yon
• Hôpital de la Louvière — Lille
• CHU Limoges — Limoges
• … и ещё 10 центров

Идентификаторы

NCT: NCT06170736 · CHD22_0066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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