Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 13, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
Official Title  ICMJE Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemorrhoids
  • Surgical Procedure, Unspecified
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Procedure: Radiofrewuency surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Barba +330664888704 ext +330664888704 mh.barba@ecten.eu
Contact: Jean Francois OUDET +33683346567 ext +33683346567 jf.oudet@ecten.eu
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04229784
Other Study ID Numbers  ICMJE 2018-A03220-55
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ramsay Générale de Santé
Study Sponsor  ICMJE Ramsay Générale de Santé
Collaborators  ICMJE Dr Abramowitz
Investigators  ICMJE Not Provided
PRS Account Ramsay Générale de Santé
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP