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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229784
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Dr Abramowitz
Information provided by (Responsible Party):
Ramsay Générale de Santé

Brief 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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Surgical Procedure, Unspecified Procedure: Radiofrewuency surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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




Primary Outcome Measures :
  1. HEMO-FISS-QoL [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229784


Contacts
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Contact: Marie Barba +330664888704 ext +330664888704 mh.barba@ecten.eu
Contact: Jean Francois OUDET +33683346567 ext +33683346567 jf.oudet@ecten.eu

Locations
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France
BLOMET clinic Recruiting
Paris, IDF, France, 75015
Contact: Marie Barba    +330664888704 ext +330664888704    mh.barba@ecten.eu   
Contact: Jean Francois OUDET    +33683346567 ext +33683346567    jf.oudet@ecten.eu   
Sponsors and Collaborators
Ramsay Générale de Santé
Dr Abramowitz

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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT04229784    
Other Study ID Numbers: 2018-A03220-55
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramsay Générale de Santé:
hemorrhoids
radiofrequency surgery
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases