Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease (RF-GREP)

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhoids; Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: Radiofrewuency surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75015
      • Recruiting
      • BLOMET clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female consultant for a grade II or III haemorrhoidal pathology after failure of medical-instrumental treatments.
• Age > 18 years old and < 75 years old
• Patient having signed an informed consent
• Affiliate or beneficiary of a social security scheme
• For patients taking anti-vitamin K (AVK) or oral anticoagulants (OACs) a short stop will be recommended according to HAS recommendations.
• For patients on antiplatelet agents (APA), the relay and stopping procedures will be carried out according to the current recommendations of the HAS (26)
• Patient eligible to be an outpatient

Exclusion Criteria:

• Patient with IBD (inflammatory bowel diseases)
• Patient with haematological disease at risk of bleeding
• Patient with anal fistulas
• Patient unable to interrupt VKAs, OACs or APAs.
• Patient with an associated anal fissure
• External hemorrhoidal pathology
• Patient participating in another clinical study
• Pregnant or lactating women
• Patient with pacemaker or implantable defibrillator
• Protected patient: adult under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RF ARM; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEMO-FISS-QoL	The primary endpoint for assessing changes in the patient's quality of life will be the total score obtained on the HEMO-FISS-QoL Quality of Life Questionnaire at 3 months.	3 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Dr Abramowitz

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: hemorrhoids; radiofrequency surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: 2018-A03220-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No