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Infected Pilonidal SinusRaTPiDNCT05855733

Radiofrequency Treatment for Pilonidal Disease : Safety of Use, Efficacy and Patient Satisfaction at 6 Months

A study testing radiofrequency treatment in people with Infected Pilonidal Sinus, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Infected pilonidal sinus is a common suppuration that occurs twice as often in men as in women, usually between the ages of 15 and 30. Clinical diagnosis is easy, whether the presentation is acute or chronic. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infected Pilonidal Sinus
What is being tested?
radiofrequency treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
3 Jul 2023to Sep 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient presenting an infected pilonidal sinus requiring an surgical procedure, at the exception of acute abscess stage
  • Patient aged 18 or above
  • For Women Of Child Bearing Age, use of efficient contraceptive (less than 1% failure)
  • Patient with health insurance coverage
  • French-speaking patient
  • Signed written informed consent

Who cannot join

  • Patient already included in a type 1 interventional research protocol (RIPH1)
  • Patient with cardiac disease (including pacemaker)
  • Patient with skin infection
  • Patient for whom local or general anesthesia is contraindicated
  • patient presenting an anal infectious disease, or an anal fissure or who have previously had a stapled hemorrhoidopexy (Longo procedure) with metallic staples.
  • Patient using anticoagulant or anti-platelet agent (at the exception of aspirin)
Show all 13Show fewer
  • Patient suffering from innate hemostasis and/or coagulation disorder
  • Patient for whom MRI is contraindicated
  • Pregnant or Breastfeeding women
  • Patient under guardianship or curatorship
  • Patient incarcerated
  • Patient under legal protection
  • Patient refusing follow-up

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Paris Saint-Joseph

    Paris

Other trials in France

About this study

Official title: Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months

Infected pilonidal sinus is a common suppuration that occurs twice as often in men as in women, usually between the ages of 15 and 30. Clinical diagnosis is easy, whether the presentation is acute or chronic. Exeresis with a wound left open requiring secondary postoperative healing is the most widely practiced technique in France because its recurrence rate is the lowest, but it has the disadvantage of requiring daily or even twice-daily local nursing care, long healing, and a break in activity.

In order to limit the disadvantages of the open technique, "conservative" minimally invasive techniques have also recently been developed in response to strong patient demand: such as endoscopic treatment (EPSIT = Endoscopic Pilonidal Sinus Treatment, or VAAPS = Video-Assisted Ablation of Pilonidal Sinus), or the SiLaT (Sinus Laser Therapy) laser.

Read more

More recently, radiofrequency has emerged as a new technique in the treatment of hemorrhoidal pathology according to the Rafaelo procedure as well as the Fistura procedure for anal fistulas. The principle of the treatment is similar to that of the laser, based on radio frequency thermocoagulation using very high frequency electromagnetic waves (4MHz), similar to the principle of microwaves. However, its use in the infected pilonidal sinus has not yet been described. The fibers used in anal fistulas are perfectly adapted to the treatment of the pilonidal sinus. In addition, and in contrast to the laser, several fiber diameters are available depending on the size of the fistula path(s). For example, the large diameters of 9 Fr seem to be more adapted to the deep and wide cavities of the pilonidal sinuses than those of the SiLaT, which has a single fiber diameter. The investigators can therefore think that this type of fibers could allow a more efficient destruction of the granulation tissues and a better docking of the cavity walls.

According to published studies in the treatment of anal fistulas, the safety profile of this treatment is perfectly reassuring since the penetrance of the energy released does not exceed 3 mm in depth.

The aim of this study is to propose a competing alternative to the SiLaT laser, which is radiofrequency according to the Fistura® procedure, by evaluating its safety, efficacy and patient satisfaction on a series of consecutive patients treated

Being tested
radiofrequency treatment
Keywords
Radiofrequency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiofrequency treatmentDevice

    patient undergoing radiofrequency using the Fistura procedure for treatment of a infected pilonidal sinus

Study groups in NCT05855733
Study groupRoleWhat they receive
RadiofrequencyExperimentaltreatment of pilonidal disease according to the Fistura procedure
Receives: Device: radiofrequency treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of at least one complication of the surgery

    incidence rate of haemorrhagic complication or acute urinary retention or other complication (such as post surgery abcess, localized infection, haematoma)

    Measured: Within 15days after surgery

Secondary outcomes (7)

  1. Incidence rate of of haemorrhagic complication after surgery

    Measured: Within 15days after surgery

  2. Incidence rate of acute urinary retention after surgery

    Measured: Within 15days after surgery

  3. Incidence rate of other complication of surgery

    incidence rate of other complication such as post surgery abcess, localized infection, haematoma

    Measured: Within 15days after surgery

  4. Evaluation of post-surgery pain

    Patient will be asked daily to evaluate post surgery pain using a Numerical Rating Scale (NRS). Patients will be asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero represents 'no pain at all' whereas10 represents 'the worst pain ever possible'.

    Measured: within 15 days post surgery

  5. Evaluation of radiofrequency treatment efficiency

    During the last patient visit, a clinical evaluation will be performed during which closure of all existing fistula external opening will be assessed (Yes or No), as well as the absence or presence of abcess and new external opening (Yes or no) . The patient will be asked to evaluate the presence or absence of pain (yes or no)

    The Treatment will be evaluated as efficient if there is closure of all fistula external opening AND absence of pain AND absence of abscess or new external opening

    Measured: 6 months after surgery

  6. Length of the medical leave after surgery

    Record of number of medical leave days prescribed after surgery Record of number of day after surgery necessary before returning to normal activity.

    Measured: within 6 months post surgery

  7. Measurement of patient satisfaction after surgery

    patient will evaluate their satisfaction regarding their surgery using a visual 5 point scale ranking from "very unsatified" to "very satisfied"

    Measured: 1 month and 6 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start3 Jul 2023
  3. Primary completion25 Jan 2024
  4. Study completionSep 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855733
Sponsor's protocol ID
RaTPiD
Acronym
RaTPiD
Status last verified
Mar 2024
First submitted
17 Apr 2023
Last updated
12 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Velotti N, Manigrasso M, Di Lauro K, Araimo E, Calculli F, Vertaldi S, Anoldo P, Aprea G, Simone G, Vitiello A, Musella M, Milone M, De Palma GD, Milone F, Sosa Fernandez LM. Minimally Invasive Pilonidal Sinus Treatment: A Narrative Review. Open Med (Wars). 2019 Aug 7;14:532-536. doi: 10.1515/med-2019-0059. eCollection 2019.

    PubMed 31428682

  • Romic I, Augustin G, Bogdanic B, Bruketa T, Moric T. Laser treatment of pilonidal disease: a systematic review. Lasers Med Sci. 2022 Mar;37(2):723-732. doi: 10.1007/s10103-021-03379-x. Epub 2021 Jul 22.

    PubMed 34291332

  • Meinero P, Mori L, Gasloli G. Endoscopic pilonidal sinus treatment (E.P.Si.T.). Tech Coloproctol. 2014 Apr;18(4):389-92. doi: 10.1007/s10151-013-1016-9. Epub 2013 May 17.

    PubMed 23681300

  • Keogh KM, Smart NJ. The proposed use of radiofrequency ablation for the treatment of fistula-in-ano. Med Hypotheses. 2016 Jan;86:39-42. doi: 10.1016/j.mehy.2015.11.019. Epub 2015 Nov 26.

    PubMed 26804594

  • Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR. Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.

    PubMed 31399891

  • Fathallah N, Alam AA, Skoufou M, Lazareth M, Spindler L, Aubert M, Safa Far E, Pommaret E, Barre A, Wisniewski M, Kurt S, Marone D, de Parades V. Radiofrequency for the treatment of pilonidal disease: results of a French prospective pilot study. Ann Coloproctol. 2026 Apr;42(2):198-207. doi: 10.3393/ac.2025.00850.0121. Epub 2026 Apr 23.

    PubMed 42266120

Questions about this trial

What is this clinical trial studying?

A study testing radiofrequency treatment in people with Infected Pilonidal Sinus, run by Fondation Hôpital Saint-Joseph at 1 site 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 6 inclusion and 13 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of at least one complication of the surgery (time frame: Within 15days after surgery). 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 NCT05855733, which also lists 6 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 12 Mar 2024.

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