HemorrhoidsRADONCT04896268
Efficacy and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
A study testing Radiofrequency and Arterial ligation then recto-anal repair with Doppler in people with Hemorrhoids, run by Elsan at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Radiofrequency and Arterial ligation then recto-anal repair with Doppler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jan 2023to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- External haemorrhoidal disease
- Pregnant or breastfeeding women
- Patients under legal protection
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Private hospital Guillaume de Varye
Saint-Doulchard, 18230
Pflieger Hannah, MD, (0)2 48 68 85 63 ext. +33, docteurhannahpflieger@gmail.com
- Not yet recruiting
Centre Clinical
Soyaux, 16800
Anne-Sophie DIDNEE, MD
Corine BUSTREAU, corine.bustreau@elsan.care
About this study
Official title: Prospective, Multicentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
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
- Being tested
- Radiofrequency, Arterial ligation then recto-anal repair with Doppler
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
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.
Arterial ligation then recto-anal repair with DopplerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Arterial ligation then recto-anal repair with Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-month visit
Secondary outcomes (7)
Pain evaluation
Numerical scale (minimum: 0; maximum: 10)
Measured: 1-month visit
Pain evaluation
Numerical scale (minimum: 0; maximum: 10)
Measured: 6-month visit
feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant.
Success rate of radiofrequency procedure to be compared between patients taking or not taking AAP, AOD or VKA
Measured: 6-month visit
Occurrence of a relapse
date of relapse, if relapse
Measured: through study completion, an average of 6 months
Recording of specific symptoms that indicate improvement in hemorrhoidal disease
Occurrence of bleeding / prolapse
Measured: through study completion, an average of 6 months
Time to return to work
Duration of work interruption (in days)
Measured: through study completion, an average of 6 months
Safety evaluation
Adverse event
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start3 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896268
- Sponsor's protocol ID
- RADO study
- Acronym
- RADO
- Status last verified
- Jun 2024
- First submitted
- 17 May 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16843876Brown 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.
PubMed 27236344Loder 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.
PubMed 7922085Morgado 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.
PubMed 3378471Pigot 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.
PubMed 16518286Riss 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.
PubMed 21932016Simillis 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.
PubMed 26420725CRETON 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
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.
PubMed 26279839VIVALDI.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
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology
- ClinicalTrials.gov ID
- NCT04896268
- Acronym / sponsor ID
- RADO / RADO study
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, prospective, therapeutic, comparative, parallel group, randomised controlled open-label, superiority, single-centre, national study.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Device: RadiofrequencyRafaelo'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. |
| Arterial ligation then recto-anal repair with Doppler | Active comparator | Device: Arterial ligation then recto-anal repair with DopplerArterial 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyRafaelo'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. | Device | Radiofrequency |
| Arterial ligation then recto-anal repair with DopplerThe 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. | Device | Arterial ligation then recto-anal repair with Doppler |
Primary outcome
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
Time frame: 1-month visit
The Haemorrhoidal Disease and Anal Fissure questionnaire
7 secondary outcomes
Pain evaluation
Time frame: 1-month visit
Pain evaluation
Time frame: 6-month visit
feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant.
Time frame: 6-month visit
Occurrence of a relapse
Time frame: through study completion, an average of 6 months
Recording of specific symptoms that indicate improvement in hemorrhoidal disease
Time frame: through study completion, an average of 6 months
Time to return to work
Time frame: through study completion, an average of 6 months
Safety evaluation
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 16843876Aigner 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.
- Background: PubMed 27236344Brown 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.
- Background: PubMed 7922085Loder 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.
- Background: PubMed 3378471Morgado 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.
- Background: PubMed 16518286Pigot 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.
- Background: PubMed 21932016Riss 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.
- Background: PubMed 26420725Simillis 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.
- BackgroundCRETON 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: PubMed 26279839Becq 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.
- BackgroundVIVALDI.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
- BackgroundBORD 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency and Arterial ligation then recto-anal repair with Doppler in people with Hemorrhoids, run by Elsan at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pflieger Hannah, MD ((0)2 48 68 85 63 ext. +33, docteurhannahpflieger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1-month visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896268, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.