Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients consulting for a recurrence of pilonidal sinus previously treated as first-line treatment by radical surgery or laser.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: radical surgery
Group B: laser treatment

Trial outcomes

Primary outcomes

1

Impact of recurrence of pilonidal cyst on patient's quality of life

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.

Time frame
Day 0

Secondary outcomes

1

The intensity of pain and discomfort

The intensity of pain and discomfort will be assessed using a simple numerical scale ranging from 0 (no pain/discomfort) to 10 (worst pain/discomfort ever experienced).

Time frame
Day 0
2

Quality of life assessment with Wound QoL17 questionnaire

The Wound QoL17 is a questionnaire on quality of life in relation to chronic wounds. It comprises 17 items relating to the patient's experience over the last 7 days, which can be classified into three categories relating to daily life, the body and the psyche.

Time frame
Day 0

Other outcomes

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