Impact of pilonidal cyst recurrence after surgery or laser on quality of life

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinique de la Sauvegarde
  Lyon, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.