Status:
RECRUITING
Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
Lead Sponsor:
Centre Hospitalier Departemental Vendee
Conditions:
Haemorrhoids
Internal Haemorrhoids
Eligibility:
All Genders
18-80 years
Phase:
NA
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 bee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2028
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06170736
Start Date
February 21 2024
End Date
September 15 2028
Last Update
August 19 2025
Active Locations (16)
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1
Centre Hospitalier Universitaire
Amiens, France
2
Centre Hospitalier Universitaire
Angers, France
3
Maison de Santé Bagatelle
Bordeaux, France, 33000
4
Centre Hospitalier Privé
Brest, France