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

NCT07557589 | Not Yet Recruiting

• 1 other identifier: 2024-A02155-42B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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. 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 evaluate the radiofrequency treatment according to the Fistura® procedure, by mesure its safety, efficacy and patient satisfaction on a series of consecutive patients treated for infected sinus pilonidal.

Conditions

Infected Pilonidal Sinus

Keywords

Infected Pilonidal Sinus; Radiofrequency; Safety; Efficacy; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Evaluation of radiofrequency treatment safety

  Incidence rate of at least one complication of the radiofrequency treatment : incidence rate of of haemorrhagic complication, incidence rate of acute urinary retention and incidence rate of others complications such as post radiofrequency treatment abcess, haematoma, localized infection.

  Within 15days after the radiofrequency treatment

Secondary Outcomes (7)

• Evaluation of radiofrequency treatment safety

  Within 15days after the radiofrequency treatment

• Evaluation of radiofrequency treatment safety

  Within 15days after the radiofrequency treatment

• Evaluation of radiofrequency treatment safety

  Within 15days after the radiofrequency treatment

• Evaluation of post radiofrequency pain

  Within 15days after the radiofrequency treatment

• Evaluation of radiofrequency treatment efficiency

  6 months after the radiofrequency treatment

Study Arms (1)

Radiofrequency using the Fistura procedure

EXPERIMENTAL

Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus

Device: Radiofrequency treatment

Interventions

Radiofrequency treatment DEVICE

Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus

Radiofrequency using the Fistura procedure

Eligibility Criteria

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

You may qualify if:

• Patient presenting an infected pilonidal sinus at the exception of acute abscess stage requiring an surgical procedure
• 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
• Patient who has given their free, informed and written consent

You may not qualify if:

• Patient already included in a type 1 interventional research protocol (RIPH1)
• Patient with cardiac disease (including pacemaker)
• Patient with skin infection
• Patient with acute abcess
• Patient with suppurated cavity requiring urgent drainage
• Patient for whom local or general anesthesia is contraindicated, with an anal infectious disease, or an anal fissure or who have previously had a stapled hemorrhoidopexy (Longo procedure) with metallic staples
• Patient treated by aspririn or anticoagulant
• Patient with bleeding or coagulation disorder
• Allergic patient to nickel and chromium
• Pregnant or Breastfeeding women
• Patient under guardianship or curatorship
• Patient incarcerated
• Patient under legal protection
• Patient refusing follow-up
• Patient for whom MRI is contraindicated

Sponsors & Collaborators

• Ch Mont de Marsan: lead
• Centre Hospitalier de Dax: collaborator

Study Sites (2)

Centre Hospitalier de Dax

Dax, 40100, France

Location

CHi De Mont de Marsan

Mont-de-Marsan, 40024, France

Location

Related Publications (9)

• Merlini l'Heritier A, Siproudhis L, Bessi G, Le Balc'h E, Wallenhorst T, Bouguen G, Brochard C. Sphincter-sparing surgery for complex anal fistulas: radiofrequency thermocoagulation of the tract is of no help. Colorectal Dis. 2019 Aug;21(8):961-966. doi: 10.1111/codi.14618. Epub 2019 Apr 3.

  PMID: 30897291 BACKGROUND

• Spindler L, Alam A, Fathallah N, Rentien AL, Draullette M, Pommaret E, Thierry ML, Mituialy AE, Abbes L, Aubert M, Benfredj P, Far ES, Beaussier H, de Parades V. Extensive suppuration and being overweight are factors associated with the failure of laser treatment for pilonidal disease: lessons from the first French retrospective cohort. Tech Coloproctol. 2022 Feb;26(2):143-146. doi: 10.1007/s10151-021-02552-2. Epub 2021 Dec 2.

  PMID: 34855026 BACKGROUND

• 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.

  PMID: 26804594 BACKGROUND

• 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.

  PMID: 31399891 BACKGROUND

• Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.

  PMID: 28056720 BACKGROUND

• Sluckin TC, Hazen SJA, Smeenk RM, Schouten R. Sinus laser-assisted closure (SiLaC(R)) for pilonidal disease: results of a multicentre cohort study. Tech Coloproctol. 2022 Feb;26(2):135-141. doi: 10.1007/s10151-021-02550-4. Epub 2022 Jan 7.

  PMID: 34993686 BACKGROUND

• 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.

  PMID: 34291332 BACKGROUND

• Meinero P, La Torre M, Lisi G, Stazi A, Carbone A, Regusci L, Fasolini F. Endoscopic pilonidal sinus treatment (EPSiT) in recurrent pilonidal disease: a prospective international multicenter study. Int J Colorectal Dis. 2019 Apr;34(4):741-746. doi: 10.1007/s00384-019-03256-8. Epub 2019 Feb 4.

  PMID: 30719564 BACKGROUND

• 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.

  PMID: 31428682 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

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: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)