NCT04229784

Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage. The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment. The use of a radiofrequency is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue. In France, no studies have been carried out to evaluate this new technique.

Detailed description

Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus (internal hemorrhoids). Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage. The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment. The use of a radiofrequency current (Rafaelo technique) in the treatment of hemorrhoidal disease is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue. Although radiofrequency destruction of hemorrhoidal vascular tissue is already used in other European countries such as Poland, Germany, Belgium and Great Britain, there are very few studies on this minimally invasive surgical technique. This is particularly the case in France where no studies have been carried out to evaluate this new technique.

Conditions

• Hemorrhoids
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
PROCEDURE	Radiofrewuency surgery	The research procedure consists of radiofrequency destruction of hemorrhoidal vascular tissue. It consists in delivering a 4 MHz radiofrequency wave current delivered at low temperature by microfibre electrodes using a large disposable needle within the hemorrhoidal vascular tissue

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-01-18
• Last updated: 2020-01-18

Locations

1 site across 1 country: France