Comparing radiofrequency ablation and Doppler-guided ligation for treating hemorrhoids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of radiofrequency ablation (RFA) and Doppler-guided haemorrhoidal artery ligation (DGHAL) in treating symptomatic Grade II and III internal hemorrhoids. Both procedures are minimally invasive alternatives to traditional hemorrhoidectomy, with RFA showing promising outcomes and lower recurrence rates in preliminary studies. The trial will assess the non-inferiority of RFA compared to DGHAL in terms of failure rates, providing valuable insights into the best treatment options for patients. Participants will be monitored for postoperative outcomes to determine the most effective approach.

Why it matters

Who can join: the full rules

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
* 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's running

• Centre Hospitalier Universitaire
  Amiens, France Recruiting
• Centre Hospitalier Universitaire
  Angers, France Recruiting
• Maison de Santé Bagatelle
  Bordeaux, France Recruiting
• Centre Hospitalier Privé
  Brest, France Recruiting
• Clinique du val d'Ouest
  Écully, France Recruiting
• Centre Hospitalier Départemental de Vendée
  La Roche-sur-Yon, France Recruiting

Study contacts

• Principal investigator: Marc-Henri JEAN, Dr — Centre Hospitalier Departemental Vendée
• Study coordinator: Agnès DORION
• Email: agnes.dorion@ght85.fr
• Phone: 251446380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.