A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus (LASER SILAT)

June 9, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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 Overview

Status

Completed

Conditions

Infected Pilonidal Sinus

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France
    - Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patient hospitalized in the Proctology department of GHPSJ between 01JUN2018 and 31DEC2020 for a chronically infected pilonidal sinus

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	between 6 months and 36 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence Rate Time Frame: between 6 months and 36 months after treatment	number of recurrence in the study population	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	incidence rate of fever, abcess, acute urinary retention, bleeding or other complication	between 6 months and 36 months after treatment
description of predictive failure factors Time Frame: between 6 months and 36 months after treatment	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.	between 6 months and 36 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2018

Primary Completion (Actual)

December 21, 2020

Study Completion (Actual)

October 14, 2021

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)