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

Overview

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.

Interventions

• Device Radiofrequency treatment
  Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus

Primary outcome measures

• Evaluation of radiofrequency treatment safety [Time frame: Within 15days after the radiofrequency treatment]

Secondary outcome measures (7)

• Evaluation of radiofrequency treatment safety [Time frame: Within 15days after the radiofrequency treatment]
• Evaluation of radiofrequency treatment safety [Time frame: Within 15days after the radiofrequency treatment]
• Evaluation of radiofrequency treatment safety [Time frame: Within 15days after the radiofrequency treatment]
• Evaluation of post radiofrequency pain [Time frame: Within 15days after the radiofrequency treatment]
• Evaluation of radiofrequency treatment efficiency [Time frame: 6 months after the radiofrequency treatment]
• Length of the medical leave after the radiofrequency treatment [Time frame: Within 6 months after the radiofrequency treatment]
• Measurement of patient satisfaction after the radiofrequency treatment [Time frame: At 1 mont and 6 months after the radiofrequency treatment]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 2 centers

• Centre Hospitalier de Dax — Dax
• CH De Mont de Marsan — Mont-de-Marsan

Publications

• 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
• 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 PMID 34855026
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07557589 · 2024-A02155-42B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗