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Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease

Study acronym: RADIOLIGA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jan 15, 2026 to Feb 15, 2028
    • Study sites: 16 to 18
    • Study completion date: Sep 15, 2028 to Sep 15, 2030
    v5
  2. Study sites: 13 to 16
    • Eligibility criteria revised
    v4
  3. Site details revised at 8 of 13 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2024 to Feb 21, 2024
    • Site details revised at 13 of 13 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years. Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate \< 5%. To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids. The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease
Trial Details
NCT Number NCT06170736
Lead Sponsor Centre Hospitalier Departemental Vendee
Conditions
(from sponsor)		 Haemorrhoids, Internal Haemorrhoids, Grade II/III Haemorrhoids
Related terms Hemorrhoids
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov