Infected Pilonidal Sinus
Conditions
Keywords
Infected Pilonidal Sinus, Radiofrequency, Safety, Efficacy, Patient Satisfaction
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.
Interventions
DEVICERadiofrequency treatment
Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus
Sponsors
Ch Mont de Marsan
Centre Hospitalier de Dax
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of radiofrequency treatment safety | Within 15days after the radiofrequency treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of radiofrequency treatment safety | Within 15days after the radiofrequency treatment | Incidence rate of of haemorrhagic complication after the radiofrequency treatment |
| Evaluation of post radiofrequency pain | Within 15days after the radiofrequency treatment | 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'. |
| Evaluation of radiofrequency treatment efficiency | 6 months after the radiofrequency treatment | 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. |
| Length of the medical leave after the radiofrequency treatment | Within 6 months after the radiofrequency treatment | Record of number of medical leave days prescribed after the radiofrequency treatment Record of number of day after the radiofrequency treatmenty necessary before returning to normal activity. |
| Measurement of patient satisfaction after the radiofrequency treatment | At 1 mont and 6 months after the radiofrequency treatment | Each patient will evaluate their satisfaction regarding their radiofrequency treatment using a visual 5 point scale ranking from "very unsatified" to "very satisfied" |
Countries
France
Outcome results
None listed