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RADO: Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

Sponsor
Elsan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04896268
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Haemorrhoids are composed of tissue rich in blood vessels and are present in all individuals inside the anus (internal haemorrhoids) or under the skin of the anus (external haemorrhoids). Haemorrhoidal disease (HD) occurs when haemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or oozing. In case of failure of medical treatment, instrumental procedures or extensive disease, surgical treatment can be considered. There are two classic surgical techniques. The first is the pedicle haemorrhoidectomy of the Milligan and Morgan type. The second classic surgical technique is the Longo stapled anopexy. Recently, less invasive surgical techniques such as arterial ligation (HAL, with or without Doppler) followed by recto-anal repair (RAR for "Recto Anal Repair") and sometimes associated with mucopexy, which allows the excess mucosa to be ligated and the muco-haemorrhoidal tissue to be fixed to the rectal wall, have developed. The use of radiofrequency current (Rafaelo technique) in the treatment of haemorrhoidal disease is an innovative technique of haemorrhoidal thermocoagulation. It is a mini-invasive technique, which can be performed under sedation or short general anaesthesia (GA), with little pain, allowing a rapid return to normal life and a short time off work. Although this technique is already used in other European countries: Poland, Germany, Belgium, Great Britain (UK), there is now a Polish, German, Spanish and English study in the process of publication. There have been no studies in France to evaluate this new technique and assess its good tolerance, the duration of work stoppage, the improvement in quality of life and the evaluation of its effectiveness.

Condition or Disease Intervention/Treatment Phase
  • Device: Radiofrequency
  • Device: Arterial ligation then recto-anal repair with Doppler
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective, Monocentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Radiofrequency

Rafaelo's technique consists of delivering a low temperature 4 MHz radiofrequency wave current into the haemorrhoidal vascular tissue using a large single-use needle with microfibre electrodes at the end. The intracellular water in the tissue and the injection of a locally injectable Xylocaine cushion serve as resistance to the vaporisation waves without releasing water vapour, thus avoiding the damage usually encountered in electrosurgery. The delayed phenomenon is cell volatilisation. Vaporisation of the tissue allows significant haemostasis without burns. Tissue changes will depend directly on the temperature emitted and the duration of exposure to the radiofrequence current. The fibrosis process starts during the session and continues for several days to weeks, allowing the reduction of the haemorrhoidal cushions.

Device: Radiofrequency
Rafaelo's technique consists of delivering a low-temperature 4 MHz radiofrequency wave current into the haemorrhoidal vascular tissue using a large single-use needle with microfibre electrodes at the end.
Active Comparator: Arterial ligation then recto-anal repair with Doppler

Arterial ligation aims to "de-arterialise" the haemorrhoids by selectively decreasing the arterial flow of the haemorrhoidal plexuses while avoiding obstructing the venous return. It is distinguished from mucopexy or recto anal repair (RAR®) which fixes the prolapsed hemorrhoidal plexus. Instead of excising the haemorrhoids, the principle is to reduce their size and to restore the anatomical relationships of the haemorrhoidal plexuses in the anal canal.

Device: Arterial ligation then recto-anal repair with Doppler
The aim of arterial ligation is to "de-arterialise" the haemorrhoids by reducing the arterial flow of the haemorrhoidal plexuses while avoiding obstructing the venous return.

Outcome Measures

Primary Outcome Measures

  1. To demonstrate an increase in quality of life, at 1 month post-procedure, when haemorrhoidal disease is managed with radiofrequency versus HAL-RAR with Doppler [1-month visit]

    The Haemorrhoidal Disease and Anal Fissure questionnaire

Secondary Outcome Measures

  1. Pain evaluation [1-month visit]

    Numerical scale (minimum: 0; maximum: 10)

  2. Pain evaluation [6-month visit]

    Numerical scale (minimum: 0; maximum: 10)

  3. feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant. [6-month visit]

    Success rate of radiofrequency procedure to be compared between patients taking or not taking AAP, AOD or VKA

  4. Occurrence of a relapse [through study completion, an average of 6 months]

    date of relapse, if relapse

  5. Recording of specific symptoms that indicate improvement in hemorrhoidal disease [through study completion, an average of 6 months]

    Occurrence of bleeding / prolapse

  6. Time to return to work [through study completion, an average of 6 months]

    Duration of work interruption (in days)

  7. Safety evaluation [through study completion, an average of 6 months]

    Adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or Female consulting for hemorrhoidal pathology (grade II or III) after failure of medico-instrumental treatments.

  • Age ≥ 18 years and < 75 years

  • Mandatory affiliation to a health insurance system.

  • Patient having been informed of the study and having given informed consent

Exclusion Criteria:

  • Patients with chronic inflammatory bowel disease

  • Patients with suspected gastro-colic pathology

  • Haematological diseases

  • Anal fistulas

  • Patients unable to discontinue anti-vitamin K or oral anticoagulants

  • Associated anal fissure

  • External haemorrhoidal disease

  • Pregnant or breastfeeding women

  • Patients under legal protection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private hospital Guillaume de Varye Saint-Doulchard France 18230

Sponsors and Collaborators

  • Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elsan
ClinicalTrials.gov Identifier:
NCT04896268
Other Study ID Numbers:
  • RADO study
First Posted:
May 21, 2021
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemorrhoids

Study Results

No Results Posted as of Jul 25, 2022