Comparing radiofrequency ablation and Doppler-guided ligation for treating hemorrhoids
Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial
This study is testing whether a new method called radiofrequency ablation works as well as another method called Doppler-guided ligation for treating bothersome internal hemorrhoids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 18 sites (Amiens and 17 other locations) |
| Trial ID | NCT06170736 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic Grade II or III hemorrhoids requiring surgical management.
Not a fit: Patients with hemostasis disorders, external hemorrhoidal disease, or a history of colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and less recurrent treatment option for hemorrhoidal disease.
How similar studies have performed: While there have been successful studies on RFA for hemorrhoids, this is the first to directly compare it with DGHAL.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens and 17 other locations
- 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)
- Hôpital de la Louvière — Lille, France (Recruiting)
- CHU Limoges — Limoges, France (Recruiting)
- Clinique de la Sauvegarde — Lyon, France (Recruiting)
- Centre Hospitalier Universitaire — Nantes, France (Recruiting)
- Clinique Jules Verne — Nantes, France (Recruiting)
- Hôpital Saint Joseph — Paris, France (Recruiting)
- Institut Mutualiste Montsouris — Paris, France (Recruiting)
- Centre Hospitalier Interrégional — Poissy, France (Recruiting)
- Centre Hospitalier Universitaire — Rennes, France (Recruiting)
- Cabinet de Proctologie — Saint-Herblain, France (Not_yet_recruiting)
- hôpital d'Instruction des Armées — Saint-Mandé, France (Recruiting)
- Clinique de l'Estuaire — Saint-Nazaire, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.