HaemorrhoidsRADIOLIGANCT06170736
Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease
A study testing Doppler-Guided Haemorrhoidal Artery Ligation and Radiofrequency ablation in people with Haemorrhoids and Internal Haemorrhoids, run by Centre Hospitalier Departemental Vendee at 18 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemorrhoids, Internal Haemorrhoids, Grade II/III Haemorrhoids
- What is being tested?
- Doppler-Guided Haemorrhoidal Artery Ligation and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 18 sitesFrance
- Study dates
- 21 Feb 2024to 15 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- Patient affiliated to the social security system or entitled to it.
Who cannot join
- 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)
- History of colorectal cancer
- History of inflammatory bowel disease
Show all 12Show fewer
- History of rectal resection
- Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
- Patient who is pregnant, breastfeeding or able to procreate without effective contraception* at the time of inclusion
- Patient under guardianship, curators or deprived of liberty.
- Patient under court protection.
- oral contraceptive (pill), monthly vaginal ring, weekly transdermal patch, subcutaneous implant, intrauterine devices (IUD), or sterilisation.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
France18 sites, 18 recruiting
- Recruiting
Centre Hospitalier Universitaire
Amiens
Centre H Universitaire
Charles SABBAGH
- Recruiting
Centre Hospitalier Universitaire
Angers
Aurélien VENARA
- Recruiting
Maison de Santé Bagatelle
Bordeaux, 33000
Dominique BOUCHARD, Dr
- Recruiting
Centre Hospitalier Privé
Brest
Clément COUETTE
- Recruiting
Clinique du val d'Ouest
Écully
Philippe GUILLEM, PH
- Recruiting
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon
Marc-Henri JEAN, Dr
- Recruiting
Hôpital de la Louvière
Lille
Antoine LAMBLIN
- Recruiting
CHU Limoges
Limoges
Pierre-Alexandre FERRERO
- Recruiting
Clinique de la Sauvegarde
Lyon
Benjamin DARNIS
- Recruiting
Centre Hospitalier Universitaire
Nantes
Centre H Universitaire
Emilie DUCHALAIS-DASSONEVILLE
- Recruiting
Clinique Jules Verne
Nantes
Farouk DRISSI
- Recruiting
Hôpital Saint Joseph
Paris
Amine ALAM
- Recruiting
Institut Mutualiste Montsouris
Paris
Marie-Lise THIERRY
- Recruiting
Centre Hospitalier Interrégional
Poissy
Béatrice VINSON-BONNET
- Recruiting
Centre Hospitalier Universitaire
Rennes
Centre H Universitaire
Amandine LANDEMAINE
- Not yet recruiting
Cabinet de Proctologie
Saint-Herblain
Damien SOUDAN
- Recruiting
hôpital d'Instruction des Armées
Saint-Mandé
Anne-Cécile EZANNO
- Recruiting
Clinique de l'Estuaire
Saint-Nazaire
Yann REDON
About this study
Official title: Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority 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%.
Read more
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
- Being tested
- Doppler-Guided Haemorrhoidal Artery Ligation, Radiofrequency ablation
- Keywords
- Haemorrhoids, Radiofrequency, Doppler-guided haemorrhoidal artery ligation
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler-Guided Haemorrhoidal Artery LigationProcedure or 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 ablationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Doppler-Guided Haemorrhoidal Artery Ligation | Active comparator | Patients will be treated by DGHAL procedure. Receives: Procedure: Doppler-Guided Haemorrhoidal Artery Ligation |
| Radiofrequency Ablation | Experimental | Patients will be treated by radiofrequency ablation. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start21 Feb 2024
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Henri JEAN, Dr, Principal investigator, Centre Hospitalier Departemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170736
- Sponsor's protocol ID
- CHD22_0066
- Acronym
- RADIOLIGA
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06170736
- Acronym / sponsor ID
- RADIOLIGA / CHD22_0066
- Keywords
- Haemorrhoids, Radiofrequency, Doppler-guided haemorrhoidal artery ligation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Sep 2030 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doppler-Guided Haemorrhoidal Artery Ligation | Active comparator | Procedure: Doppler-Guided Haemorrhoidal Artery LigationPatients will be treated by DGHAL procedure. |
| Radiofrequency Ablation | Experimental | Procedure: Radiofrequency ablationPatients will be treated by radiofrequency ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
- Patient affiliated to the social security system or entitled to it.
Key exclusion criteria (12 listed)
- 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)
- History of colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doppler-Guided Haemorrhoidal Artery LigationThe 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. | Procedure or surgery | Doppler-Guided Haemorrhoidal Artery Ligation |
| Radiofrequency ablationThe 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. | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Failure rate at one year post-operatively
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Haemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc-Henri JEAN, Dr principal investigator
Centre Hospitalier Departemental Vendée
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doppler-Guided Haemorrhoidal Artery Ligation and Radiofrequency ablation in people with Haemorrhoids and Internal Haemorrhoids, run by Centre Hospitalier Departemental Vendee at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnès DORION (251446380 ext. +33, agnes.dorion@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate at one year post-operatively (time frame: one year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.