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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doppler-Guided Haemorrhoidal Artery Ligation | Active Comparator | Patients will be treated by DGHAL procedure. |
|
| Radiofrequency Ablation | Experimental | Patients will be treated by radiofrequency ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doppler-Guided Haemorrhoidal Artery Ligation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnès DORION | Contact | 251446380 | +33 | agnes.dorion@ght85.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marc-Henri JEAN, Dr | Centre Hospitalier Departemental Vendée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Recruiting | Amiens | France |
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|
| Radiofrequency ablation | Procedure | 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. |
|
| Centre Hospitalier Universitaire | Recruiting | Angers | France |
|
| Maison de Santé Bagatelle | Recruiting | Bordeaux | 33000 | France |
|
| Centre Hospitalier Privé | Recruiting | Brest | France |
|
| Clinique du val d'Ouest | Recruiting | Écully | France |
|
| Centre Hospitalier Départemental de Vendée | Recruiting | La Roche-sur-Yon | France |
|
| Hôpital de la Louvière | Recruiting | Lille | France |
|
| CHU Limoges | Recruiting | Limoges | France |
|
| Clinique de la Sauvegarde | Recruiting | Lyon | France |
|
| Centre Hospitalier Universitaire | Recruiting | Nantes | France |
|
| Clinique Jules Verne | Recruiting | Nantes | France |
|
| Hôpital Saint Joseph | Recruiting | Paris | France |
|
| Institut Mutualiste Montsouris | Recruiting | Paris | France |
|
| Centre Hospitalier Interrégional | Recruiting | Poissy | France |
|
| Centre Hospitalier Universitaire | Recruiting | Rennes | France |
|
| Cabinet de Proctologie | Not yet recruiting | Saint-Herblain | France |
|
| hôpital d'Instruction des Armées | Recruiting | Saint-Mandé | France |
|
| Clinique de l'Estuaire | Recruiting | Saint-Nazaire | France |
|
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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