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

Not Applicable

Recruiting

• Conditions: Grade II/III Haemorrhoids; Haemorrhoids; Internal Haemorrhoids
• Interventions: Procedure: Doppler-Guided Haemorrhoidal Artery Ligation; Procedure: Radiofrequency ablation

• Registration Number: NCT06170736
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2024-02-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2026-01-15
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doppler-Guided Haemorrhoidal Artery Ligation	Doppler-Guided Haemorrhoidal Artery Ligation	Patients will be treated by DGHAL procedure.
Radiofrequency Ablation	Radiofrequency ablation	Patients will be treated by radiofrequency ablation.

Primary Outcome Measures

Name	Time	Method
Failure rate at one year post-operatively	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.

Trial Locations

Locations (10)

Centre Hospitalier Universitaire; 🇫🇷 Rennes, France

Centre Hospitalier Privé; 🇫🇷 Brest, France

Clinique de la Sauvegarde; 🇫🇷 Lyon, France

Hôpital de la Louvière; 🇫🇷 Lille, France

Centre Hospitalier Départemental de Vendée; 🇫🇷 La Roche sur Yon, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Clinique de l'Estuaire; 🇫🇷 Saint-Nazaire, France

Centre Hospitalier Interrégional; 🇫🇷 Poissy, France

hôpital d'Instruction des Armées; 🇫🇷 Saint-Mandé, France