Clinical trial · Observational
Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
NCT07194161CI-TRIAL-00095829SPIRITrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to describe the impact of recurrence on the quality of life of patients treated with radical surgery and laser therapy. The secondary objective is to describe in patients treated with radical surgery and laser treatment : * Intensity of pain and discomfort * Duration of nursing care since surgery * Duration of inactivity since intervention
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Cyst | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- radical surgery
- label
- laser treatment
Primary outcomes (1)
- measure
- Impact of recurrence of pilonidal cyst on patient's quality of life
- timeFrame
- Day 0
- description
- Quality of life will be assessed using the SF36 scale. The SF-36 health status questionnaire has been validated in several languages, including English. It is a generic score for assessing quality of life. An average physical score (PCS = Physical Composite Score) and an average mental score (MCS = Mental Composite Score) can be calculated using an established algorithm. The SF-36 can be used by comparing (searching for correlations) the scores of the different domains of the SF-36 in a study population with those of the normal population, or by searching for correlations between the scores of the different domains of the SF-36 and other explanatory medical, functional, social, etc. variables.
Secondary outcomes (2)
- measure
- The intensity of pain and discomfort
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.