Evaluation of the Impact of Pilonidal Cyst Recurrence on Quality of Life in Patients Previously Treated With Conventional Surgery or Laser Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pilonidal Cyst, Quality of Life. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Detailed description
This is a single-centre exploratory study of patients previously treated for a pilonidal cyst who are consulting for a recurrence.
The study consists of a single assessment, the data from which will be recorded on an electronic case report form (CRF).
The objective of this study does not impose any particular constraints. The only evaluation of the study is carried out when the patient comes in for consultation for a recurrence of a pilonidal cyst.
Quality of life will be assessed using the The MOS 36-item short-form health survey (SF-36) scale and the Wound quality of life in Chronic Wounds survey (Wound QoL17).
Pain and discomfort will be assessed using a simple numerical scale ranging from 0 to 10.
Primary outcome measures
- Impact of recurrence of pilonidal cyst on patient's quality of life [Time frame: Day 0]
Secondary outcome measures (2)
- The intensity of pain and discomfort [Time frame: Day 0]
- Quality of life assessment with Wound QoL17 questionnaire [Time frame: Day 0]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- Clinique de la Sauvegarde — Lyon
Identifiers
NCT: NCT07194161 · 2024-06-049-DARNIS-SPIRIT