NCT04229784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 18, 2020

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

January 13, 2020

Last Update Submit

January 13, 2020

Conditions

HemorrhoidsSurgical Procedure, Unspecified

Keywords

hemorrhoidsradiofrequency surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

RF ARM

EXPERIMENTAL

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

Interventions

Radiofrewuency surgeryPROCEDURE

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

RF ARM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BLOMET clinic

Paris, IDF, 75015, France

RECRUITING

Related Publications (1)

  • Laurain A, Bouchard D, Rouillon JM, Petit P, Liddo A, Vinson Bonnet B, Venara A, Didelot JM, Bonnaud G, Senejoux A, Higuero T, Delasalle P, Tarrerias AL, Devulder F, Castinel A, Thomas C, Pillant Le Moult H, Favreau-Weltzer C, Abramowitz L. French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease. Tech Coloproctol. 2023 Oct;27(10):873-883. doi: 10.1007/s10151-023-02787-1. Epub 2023 Apr 2.

    PMID: 37005961DERIVED

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Marie Barba

CONTACT

+330664888704mh.barba@ecten.eu

Jean Francois OUDET

CONTACT

+33683346567jf.oudet@ecten.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

July 1, 2019

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

January 18, 2020

Record last verified: 2019-09

Locations

FR(1)