An interventional study of radiofrequency treatment in Infected Pilonidal Sinus, sponsored by Fondation Hôpital Saint-Joseph. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Fondation Hôpital Saint-Joseph · Not applicable, Interventional, and Treatment
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
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment of pilonidal disease according to the Fistura procedure
Device: radiofrequency treatment
patient undergoing radiofrequency using the Fistura procedure for treatment of a infected pilonidal sinus
Incidence rate of at least one complication of the surgery
incidence rate of haemorrhagic complication or acute urinary retention or other complication (such as post surgery abcess, localized infection, haematoma)
Time frame: Within 15days after surgery
Incidence rate of of haemorrhagic complication after surgery
Time frame: Within 15days after surgery
Incidence rate of acute urinary retention after surgery
Time frame: Within 15days after surgery
Incidence rate of other complication of surgery
incidence rate of other complication such as post surgery abcess, localized infection, haematoma
Time frame: Within 15days after surgery
Evaluation of post-surgery 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'.
Time frame: within 15 days post surgery
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
Time frame: 6 months after surgery
Length of the medical leave after surgery
Record of number of medical leave days prescribed after surgery Record of number of day after surgery necessary before returning to normal activity.
Time frame: within 6 months post surgery
Measurement of patient satisfaction after surgery
patient will evaluate their satisfaction regarding their surgery using a visual 5 point scale ranking from "very unsatified" to "very satisfied"
Time frame: 1 month and 6 months post surgery
Ran from Jul 2023 to primary completion in Jan 2024, 6 months.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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