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

NCT04896268 | Recruiting

• 1 other identifier: RADO study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (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

  The Haemorrhoidal Disease and Anal Fissure questionnaire

  1-month visit

Secondary Outcomes (7)

• Pain evaluation

  1-month visit

• Pain evaluation

  6-month visit

• feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant.

  6-month visit

• Occurrence of a relapse

  through study completion, an average of 6 months

• Recording of specific symptoms that indicate improvement in hemorrhoidal disease

  through study completion, an average of 6 months

Study Arms (2)

Radiofrequency

EXPERIMENTAL

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

Arterial ligation then recto-anal repair with Doppler

ACTIVE COMPARATOR

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

Interventions

Radiofrequency DEVICE

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.

Radiofrequency

Arterial ligation then recto-anal repair with Doppler DEVICE

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.

Arterial ligation then recto-anal repair with Doppler

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (2)

Private hospital Guillaume de Varye

Saint-Doulchard, 18230, France

RECRUITING

Centre Clinical

Soyaux, 16800, France

NOT YET RECRUITING

Related Publications (11)

• Aigner F, Bodner G, Gruber H, Conrad F, Fritsch H, Margreiter R, Bonatti H. The vascular nature of hemorrhoids. J Gastrointest Surg. 2006 Jul-Aug;10(7):1044-50. doi: 10.1016/j.gassur.2005.12.004.

  PMID: 16843876 BACKGROUND

• Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.

  PMID: 27236344 BACKGROUND

• Loder PB, Kamm MA, Nicholls RJ, Phillips RK. Haemorrhoids: pathology, pathophysiology and aetiology. Br J Surg. 1994 Jul;81(7):946-54. doi: 10.1002/bjs.1800810707.

  PMID: 7922085 BACKGROUND

• Morgado PJ, Suarez JA, Gomez LG, Morgado PJ Jr. Histoclinical basis for a new classification of hemorrhoidal disease. Dis Colon Rectum. 1988 Jun;31(6):474-80. doi: 10.1007/BF02552621.

  PMID: 3378471 BACKGROUND

• Pigot F, Siproudhis L, Allaert FA. Risk factors associated with hemorrhoidal symptoms in specialized consultation. Gastroenterol Clin Biol. 2005 Dec;29(12):1270-4. doi: 10.1016/s0399-8320(05)82220-1.

  PMID: 16518286 BACKGROUND

• Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

  PMID: 21932016 BACKGROUND

• Simillis C, Thoukididou SN, Slesser AA, Rasheed S, Tan E, Tekkis PP. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015 Dec;102(13):1603-18. doi: 10.1002/bjs.9913. Epub 2015 Sep 30.

  PMID: 26420725 BACKGROUND

• CRETON D. et le groupe closure®.Oblitération tronculaire saphène par le procédé radiofréquence VNUS Closure ®. résultats à 5 ans de l'étude multicentrique prospective,Phlébologie 2006,59 :67-72

  BACKGROUND

• Becq A, Camus M, Rahmi G, de Parades V, Marteau P, Dray X. Emerging indications of endoscopic radiofrequency ablation. United European Gastroenterol J. 2015 Aug;3(4):313-24. doi: 10.1177/2050640615571159.

  PMID: 26279839 BACKGROUND

• VIVALDI.C,. TOLKSDORFS. SCHAFER H., Radiofrequency ablation of hemorroïds. First results of a new technique The Rafaelo Procedure.Endarmpraxis;Colorectal disease 2017, 19 (suppl 2) p.138

  BACKGROUND

• BORD C., PILLANT H., FAVREAU-WELTZER C., SENEJOUX A., SOUDAN D., ARREDONDO BISONO T., ZKIK A., BERDEAU G., ABRAMOWITZ L. Development of A Validated Questionnaire Evaluating The Burden of The Haemorrhoidal Disease and Anal Fissure (Hemo-Fiss). Value in Health, VOLUME 18, ISSUE 7, PA630, NOVEMBER 01, 2015

  BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Interventions

Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Pflieger Hannah, MD

CONTACT

(0)2 48 68 85 63; docteurhannahpflieger@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 21, 2021
• Study Start: January 3, 2023
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

FR (2)