Comparing radiofrequency and Doppler-assisted techniques for treating hemorrhoids
Prospective, Multicentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
This study is testing whether a new radiofrequency treatment works better than a Doppler-assisted method for helping people with grade II or III hemorrhoids who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 2 sites (Saint-Doulchard and 1 other locations) |
| Trial ID | NCT04896268 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of two surgical techniques for treating hemorrhoidal disease: radiofrequency and arterial ligation followed by recto-anal repair with Doppler guidance. The study targets patients with grade II or III hemorrhoids who have not responded to medical treatments. Participants will be monitored for symptom relief and any potential complications following the procedures. The trial aims to determine which method provides better outcomes for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with grade II or III hemorrhoids who have failed previous medical treatments.
Not a fit: Patients with chronic inflammatory bowel disease, anal fistulas, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less invasive treatment options for patients with hemorrhoidal disease.
How similar studies have performed: Other studies have explored similar minimally invasive techniques for hemorrhoids, indicating potential for success, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female consulting for hemorrhoidal pathology (grade II or III) after failure of medico-instrumental treatments. * Age ≥ 18 years and \< 75 years * Mandatory affiliation to a health insurance system. * Patient having been informed of the study and having given informed consent Exclusion Criteria: * Patients with chronic inflammatory bowel disease * Patients with suspected gastro-colic pathology * Haematological diseases * Anal fistulas * Patients unable to discontinue anti-vitamin K or oral anticoagulants * Associated anal fissure * External haemorrhoidal disease * Pregnant or breastfeeding women * Patients under legal protection
Where this trial is running
Saint-Doulchard and 1 other locations
- Private hospital Guillaume de Varye — Saint-Doulchard, France (Recruiting)
- Centre Clinical — Soyaux, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Pflieger Hannah, MD
- Email: docteurhannahpflieger@gmail.com
- Phone: (0)2 48 68 85 63
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.