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

Last updated: April 17, 2024
Sponsor: Centre Hospitalier Departemental Vendee
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhoids

Treatment

Doppler-Guided Haemorrhoidal Artery Ligation

Radiofrequency ablation

Clinical Study ID

NCT06170736
CHD22_0066
  • Ages 18-80
  • All Genders

Study 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

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 toparticipate in the study,
  • Patient affiliated to the social security system or entitled to it.

Exclusion

Exclusion Criteria:

  • Hemostasis disorders
  • Associated external haemorrhoidal disease (thrombosis)
  • History of surgical procedure for treatment of haemorrhoids (instrumental treatment isnot a contra-indication)
  • Associated proctological pathology (anal fissure, chronic suppuration, external rectalprolapse)
  • History of colorectal cancer
  • History of inflammatory bowel disease
  • History of rectal resection
  • Patient participating in another interventional clinical research protocol involving adrug or clinical investigation of a medical device
  • Patient who is pregnant, breastfeeding or able to procreate without effectivecontraception* 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

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: Doppler-Guided Haemorrhoidal Artery Ligation
Phase:
Study Start date:
February 21, 2024
Estimated Completion Date:
September 15, 2028

Connect with a study center

  • Centre Hospitalier Universitaire

    Amiens,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire

    Angers,
    France

    Active - Recruiting

  • Centre Hospitalier Privé

    Brest,
    France

    Site Not Available

  • Centre Hospitalier Départemental de Vendée

    La Roche sur Yon,
    France

    Active - Recruiting

  • Hôpital de la Louvière

    Lille,
    France

    Active - Recruiting

  • Clinique de la Sauvegarde

    Lyon,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire

    Nantes,
    France

    Active - Recruiting

  • Hôpital Saint Joseph

    Paris,
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier Interrégional

    Poissy,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire

    Rennes,
    France

    Active - Recruiting

  • hôpital d'Instruction des Armées

    Saint-Mandé,
    France

    Active - Recruiting

  • Clinique de l'Estuaire

    Saint-Nazaire,
    France

    Site Not Available

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