Long-term outcomes of HAL Doppler or HAL-RAR treatment for hemorrhoids
Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After Hemorrhoidal Artery Ligation (HAL)
This study looks at how well HAL Doppler and HAL-RAR treatments for hemorrhoids work over the long term by checking if patients have any recurrence of their symptoms at least 10 years after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT04731064 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the recurrence rate of hemorrhoidal disease in patients who have undergone HAL Doppler or HAL-RAR interventions at least 10 years prior. The HAL technique involves the ligation of hemorrhoidal arteries and recto-anal repair to address both vascular and mechanical aspects of the condition. Patients are treated under various anesthesia options, often on an outpatient basis, following rectal preparation. The study aims to gather long-term data on the effectiveness of these treatments in preventing recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have undergone treatment for hemorrhoidal disease at least 10 years ago.
Not a fit: Patients who are minors or those who oppose participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of HAL Doppler and HAL-RAR treatments for hemorrhoidal disease.
How similar studies have performed: While the HAL technique has been used in various countries, this study specifically focuses on long-term outcomes, making it a novel approach in assessing recurrence rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient operated for hemorrhoidal disease for 10 or more * Age 18 and over * Informed patients Exclusion Criteria: * Patient opposition * Minor patient
Where this trial is running
Grenoble
- CHU Grenoble-alpes — Grenoble, France (Recruiting)
Study contacts
- Principal investigator: Giorgia Mastronicola — CHU Grenoble Alpes
- Study coordinator: Giorgia Mastronicola, MD
- Email: GMastronicola@chu-grenoble.fr
- Phone: 0033476767079
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.