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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Departemental Vendee

About this trial

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

Eligibility criteria

Qualifiers

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,

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Doppler-Guided Haemorrhoidal Artery Ligation
  • Radiofrequency ablation

Treatment groups

168 Participants
are divided into 2 treatment groups