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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Doppler-Guided Haemorrhoidal Artery Ligation

    Procedure/Surgery

    The principle consists of locating the signal emitted by the haemorrhoidal arteries using a Doppler probe. Once identified, the arteries are ligated in order to remove the arterial vascularization of the haemorrhoidal bundles. The treatment of the prolapse is reinforced by a folding of the mucosa of the lower rectum, called mucopexy.

  • Radiofrequency ablation

    Procedure/Surgery

    The principle consists of inserting a metal probe under the mucosa of the anus, in contact with the haemorrhoidal bundles to be treated. A source of radiofrequency is then delivered through this probe in contact with the haemorrhoidal veins which will be sclerosed. The procedure is repeated for each haemorrhoidal bundle to be treated.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Doppler-Guided Haemorrhoidal Artery LigationActive comparator 1 intervention
Group B: Radiofrequency AblationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Failure rate at one year post-operatively

The evaluation of failure rate will be based on the calculation of the HDSS score grouping the different symptoms (pain, discomfort, bleeding, soiling and prolapse). Failure rate will be defined by a score greater than or equal to the preoperative score or by a reoperation (surgical or instrumental) for relapse of the symptoms.

Time frame
one year post-operatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.