Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900518
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2023-05-31
Brief Title:
A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LASER SILAT
Brief Summary:
Infected pilonidal sinuses are a common pathology affecting an estimated 07 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None