Impact of pilonidal cyst recurrence after surgery or laser on quality of life
Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
This project will see how recurring pilonidal cysts after prior surgery or laser affect quality of life for patients who come back with a recurrence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07194161 on ClinicalTrials.gov |
What this trial studies
This single-center observational project enrolls patients who previously underwent radical surgery or laser therapy and who are presenting for a recurrent pilonidal cyst. Each participant completes one clinic visit during which data are entered into an electronic case report form and no experimental treatments are given. Quality of life is measured with the SF-36 and Wound-QoL17 questionnaires, and pain is recorded on a 0–10 numeric scale; the study also documents duration of nursing care and time away from normal activities. Recurrence is defined clinically as persistent troublesome symptoms more than six months after surgery or by characteristic MRI findings when available.
Who should consider this trial
Good fit: Ideal candidates are people aged 14 or older with a confirmed recurrence of a pilonidal cyst more than six months after prior radical surgery or laser therapy.
Not a fit: Patients with symptoms less than six months old, those whose first operation was limited to simple abscess drainage, or those with atypical symptoms without radiological confirmation are unlikely to benefit directly from this project.
Why it matters
Potential benefit: If successful, the findings could help tailor follow-up care and treatment choices to reduce pain and improve daily quality of life after pilonidal cyst recurrence.
How similar studies have performed: Previous research has reported quality-of-life outcomes after pilonidal procedures, but direct comparisons of recurrence impact following radical surgery versus laser remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 14 or over * Patient has been informed of the objectives and conditions of the study and has not objected to the collection of his/her data. * If the patient is under 18 years of age, both parents or the holder(s) of parental authority have been informed of their child's participation in the study and do not oppose it * Presenting a recurrence of pilonidal sinus after a first complete treatment by radical surgery or laser Recurrence is defined by : * The presence of persistent troublesome symptoms more than 6 months after surgery: suppuration, iterative scar disunion, absence of healing despite care deemed optimal by the expert, recurrence of abscesses * The presence of a characteristic MRI image, if this examination has been carried out: subcutaneous collection, in hyper T2. Exclusion Criteria: * Symptoms less than 6 months old * First operation limited to simple abscess flattening * Atypical symptoms, without radiological confirmation of recurrence: isolated pain, induration without inflammatory phenomena * History of more than one elective surgery for pilonidal sinus * Pilonidal sinus associated with a posteriorly developed anal fistula * Persistence of a skin orifice, with no hair in it, without any symptoms * Patient under court protection, guardianship or curatorship * Mental deficiency or any other reason that may hinder comprehension of the information and non-opposition note0
Where this trial is running
Lyon
- Clinique de la Sauvegarde — Lyon, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.