Clinical trial NCT05855733: Radiofrequency Treatment for Pilonidal Disease : Safety of Use, Efficacy and Patient Satisfaction at 6 Months
Official title: Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infected Pilonidal Sinus
Keywords: Radiofrequency
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Incidence rate of at least one complication of the surgery
timeFrame: Within 15days after surgery
Secondary outcomes:
measure: Incidence rate of of haemorrhagic complication after surgery
timeFrame: Within 15days after surgery
measure: Incidence rate of acute urinary retention after surgery
timeFrame: Within 15days after surgery
measure: Incidence rate of other complication of surgery
timeFrame: Within 15days after surgery
measure: Evaluation of post-surgery pain
timeFrame: within 15 days post surgery
measure: Evaluation of radiofrequency treatment efficiency
timeFrame: 6 months after surgery
measure: Length of the medical leave after surgery
timeFrame: within 6 months post surgery
measure: Measurement of patient satisfaction after surgery
timeFrame: 1 month and 6 months post surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.