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| Name | Class |
|---|---|
| Centre Hospitalier de Dax | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency using the Fistura procedure | Experimental | Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency treatment | Device | Radiofrequency using the Fistura procedure for treatment of infected pilonidal sinus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of radiofrequency treatment safety | Incidence rate of of haemorrhagic complication after the radiofrequency treatment | Within 15days after the radiofrequency treatment |
| Evaluation of radiofrequency treatment safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Dax | Recruiting | Dax | 40100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30897291 | Background | 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. | |
| 34855026 | Background |
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Incidence rate of acute urinary retention after the radiofrequency treatment
| Within 15days after the radiofrequency treatment |
| Evaluation of radiofrequency treatment safety | Incidence rate of others complications such as post radiofrequency treatment abcess, haematoma, localized infection. | Within 15days after the radiofrequency treatment |
| Evaluation of post radiofrequency 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'. | Within 15days after the radiofrequency treatment |
| 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. | 6 months after the radiofrequency treatment |
| Length of the medical leave 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. | Within 6 months after the radiofrequency treatment |
| Measurement of patient satisfaction 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" | At 1 mont and 6 months after the radiofrequency treatment |
| CH De Mont de Marsan | Not yet recruiting | Mont-de-Marsan | 40024 | France |
|
| 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. |
| 26804594 | 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. |
| 31399891 | 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. |
| 28056720 | 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. |
| 34993686 | 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. |
| 34291332 | 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. |
| 30719564 | 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. |
| 31428682 | 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. |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
| D012046 | Rehabilitation |
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