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

Обзор

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

Подробное описание

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.

Первичные конечные точки

• Impact of recurrence of pilonidal cyst on patient's quality of life [Срок оценки: Day 0]

Вторичные конечные точки (2)

• The intensity of pain and discomfort [Срок оценки: Day 0]
• Quality of life assessment with Wound QoL17 questionnaire [Срок оценки: Day 0]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• Clinique de la Sauvegarde — Lyon

Идентификаторы

NCT: NCT07194161 · 2024-06-049-DARNIS-SPIRIT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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