An observational study in Infected Pilonidal Sinus, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
Infected pilonidal sinuses are a common pathology, affecting an estimated 0.7% of the population. In France, the most commun technique is extended exeresis with an open wound, followed by directed healing. This technique reduces the risk of recurrence, albeit at the cost of daily nursing care and a long healing period involving prolonged absence from work. Closure or plasty surgical techniques aimed at reducing the duration of nursing care are more restrictive, and seem to have higher recurrence rate. Minimally invasive treatment, such as phenolization and flattening with curettage of the sinus have existed for over 50 years, albeit with disappointing long-term results and morbidity that limits their application.
Today, new minimally invasive treatments are being developed, aiming at a less constraining post-operative period. without compromising healing. These include glue, endoscopic treatment (EPSiT : Endoscopic Pilonidal Sinus Treatment or VAASP : Video-Assisted Ablation of Pilonidal Sinus) and laser treatment (SiLaT procedure : Sinus Laser Therapy or PiLaT : Pilonidal disease Laser Treatment).
Laser treatment is used since 2014 in the treatment of anal fistulas and more recently in the treatment of infected pilonidal sinus. A laser fiber is introduced, under local or general anaesthesia, into the main cavity and secondary tracts after curettage and opening of the dimples. The energy delivered by the laser is transmitted in the form of heat, in order to seal the cavity during healing of thermal lesions.
Initial results report success rates of around 90%, with a healing time of between 1 and 2 months. It also appears to be effective after failure of previous surgery. In cases of incomplete closure or recurrence, a second laser treatment can be performed with high healing rates. The investigators carried out an retrospective study including 29 patients treated with the SILAT technique. The healing rate, defined as the absence of symptoms and recurrence of suppuration, was around 70%. The procedure was painless and no serious complications were observed. The presence of one or more secondary orifices and overweight were associated with a higher risk of failure.
In order to confirm these results, to better specify the factors predictive of success, and to evaluate the efficacy of SiLaT in the longer term, the investigators will carry out a single-center study including all adult patients treated with laser between June 2018 and December 2020.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 113 is below the median of 145 across 37 observational 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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Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus
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Exclusion Criteria:
Clinical cure
A clinical evaluation will be performed and Clinical cure will be defined by : closure of all existing fistula external opening AND absence of abscess, AND absence of leakage under pressure, and ABSENCE of pain
Time frame: between 6 months and 36 months after treatment
recurrence Rate
number of recurrence in the study population
Time frame: between 6 months and 36 months after treatment
Incidence rate of complication after laser treatment
incidence rate of fever, abcess, acute urinary retention, bleeding or other complication
Time frame: between 6 months and 36 months after treatment
description of predictive failure factors
incidence rate of smoking habits, diabetes, inflammatory bowel disease, anal fistula, Verneuil disease, other proctological disease, previous surgery for the infected pilonidal disease among the relapsing patients.
Time frame: between 6 months and 36 months after treatment
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2020, 29 months.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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