Infected Pilonidal SinusLASER SILATNCT05900518
A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus
An observational study of Infected Pilonidal Sinus, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infected Pilonidal Sinus
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2018to 14 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus
Who may be able to join
- Patient aged 18 or above
- French-speaking patient
- Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus
- patient presenting an recurring infected pilonidal sinus after open or closed surgical treatment
Who cannot join
- Patient hospitalized in the acute abcess stage of an infected pilonidal sinus
- Patient under guardianship or curatorship
- Patient incarcerated
- Patient under legal protection
- Patient refusing enrollment
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Infected Pilonidal Sinus
- Keywords
- laser
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between 6 months and 36 months after treatment
Secondary outcomes (3)
recurrence Rate
number of recurrence in the study population
Measured: 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
Measured: 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.
Measured: between 6 months and 36 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start27 Jun 2018
- Primary completion21 Dec 2020
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infected Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900518
- Sponsor's protocol ID
- LASER SILAT
- Acronym
- LASER SILAT
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Parades V, Bouchard D, Janier M, Berger A. Pilonidal sinus disease. J Visc Surg. 2013 Sep;150(4):237-47. doi: 10.1016/j.jviscsurg.2013.05.006. Epub 2013 Aug 1.
PubMed 23911903Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.
PubMed 30640830Pappas AF, Christodoulou DK. A new minimally invasive treatment of pilonidal sinus disease with the use of a diode laser: a prospective large series of patients. Colorectal Dis. 2018 Aug;20(8):O207-O214. doi: 10.1111/codi.14285. Epub 2018 Jun 27.
PubMed 29878584Georgiou GK. Outpatient laser treatment of primary pilonidal disease : the PiLaT technique. Tech Coloproctol. 2018 Oct;22(10):773-778. doi: 10.1007/s10151-018-1863-5. Epub 2018 Oct 10.
PubMed 30306277Dessily 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.
PubMed 28056720
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus
- ClinicalTrials.gov ID
- NCT05900518
- Acronym / sponsor ID
- LASER SILAT / LASER SILAT
- Conditions
- Infected Pilonidal Sinus
- Keywords
- laser
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus
Key inclusion criteria (4 listed)
- Patient aged 18 or above
- French-speaking patient
- Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus
- patient presenting an recurring infected pilonidal sinus after open or closed surgical treatment
Key exclusion criteria (5 listed)
- Patient hospitalized in the acute abcess stage of an infected pilonidal sinus
- Patient under guardianship or curatorship
- Patient incarcerated
- Patient under legal protection
- Patient refusing enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical cure
Time frame: between 6 months and 36 months after treatment
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
3 secondary outcomes
recurrence Rate
Time frame: between 6 months and 36 months after treatment
Incidence rate of complication after laser treatment
Time frame: between 6 months and 36 months after treatment
description of predictive failure factors
Time frame: between 6 months and 36 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 23911903de Parades V, Bouchard D, Janier M, Berger A. Pilonidal sinus disease. J Visc Surg. 2013 Sep;150(4):237-47. doi: 10.1016/j.jviscsurg.2013.05.006. Epub 2013 Aug 1.
- Background: PubMed 30640830Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.
- Background: PubMed 29878584Pappas AF, Christodoulou DK. A new minimally invasive treatment of pilonidal sinus disease with the use of a diode laser: a prospective large series of patients. Colorectal Dis. 2018 Aug;20(8):O207-O214. doi: 10.1111/codi.14285. Epub 2018 Jun 27.
- Background: PubMed 30306277Georgiou GK. Outpatient laser treatment of primary pilonidal disease : the PiLaT technique. Tech Coloproctol. 2018 Oct;22(10):773-778. doi: 10.1007/s10151-018-1863-5. Epub 2018 Oct 10.
- Background: PubMed 28056720Dessily 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.
- Individual participant dataSharing planned: No
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Infected Pilonidal Sinus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infected Pilonidal Sinus, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: between 6 months and 36 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900518, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.