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

Primary Purpose

Hemorrhoids, Surgical Procedure, Unspecified

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrewuency surgery
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoids, radiofrequency surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BLOMET clinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RF ARM

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2020
Last Updated
January 13, 2020
Sponsor
Ramsay Générale de Santé
Collaborators
Dr Abramowitz
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1. Study Identification

Unique Protocol Identification Number
NCT04229784
Brief Title
Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
Acronym
RF-GREP
Official Title
Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Dr Abramowitz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Surgical Procedure, Unspecified
Keywords
hemorrhoids, radiofrequency surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RF ARM
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Radiofrewuency surgery
Intervention Description
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 Measure Information:
Title
HEMO-FISS-QoL
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Francois OUDET
Phone
+33683346567
Ext
+33683346567
Email
jf.oudet@ecten.eu
Facility Information:
Facility Name
BLOMET clinic
City
Paris
State/Province
IDF
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
First Name & Middle Initial & Last Name & Degree
Jean Francois OUDET
Phone
+33683346567
Ext
+33683346567
Email
jf.oudet@ecten.eu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease

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