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Набор скоро начнётся NCT07470294

Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population

— Наблюдательное Sacrococcygeal Pilonidal Sinus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques..
Кому может быть актуально
Состояния в реестре: Sacrococcygeal Pilonidal Sinus. Базовые параметры: 0 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population: A 10-Year Single-Center Retrospective Comparative Cohort Study

Обзор

Pilonidal sinus disease (PSD) in children is associated with significant morbidity and recurrence risk. Multiple surgical techniques are used, including excision with open healing, primary midline closure, off-midline closure, flap reconstruction, and minimally invasive approaches. However, high-quality comparative data in pediatric populations are limited, and adult data cannot be directly extrapolated. This single-center retrospective cohort study aims to compare the effectiveness of different surgical techniques used for curative treatment of PSD in children treated at CHU Angers between January 1, 2015 and March 31, 2025. The primary endpoint is surgical failure at 2 months, defined as absence of complete wound healing or early recurrence. Secondary outcomes include postoperative complications, time to healing, pain outcomes, length of hospital stay, and recurrence at 1 year. Results are expected to help optimize institutional management strategies and contribute to pediatric-specific evidence.

Подробное описание

This is a single-center retrospective observational cohort study conducted in the Departments of Pediatric Surgery and Visceral Surgery at CHU Angers, France.

All consecutive patients under 18 years of age who underwent surgical treatment for pilonidal sinus disease between January 1, 2015 and March 31, 2025 will be included.

Surgical techniques analyzed include:

* Wide excision with open healing * Wide excision with primary midline closure * Wide excision with primary midline closure and negative pressure wound therapy * Minimally invasive/endoscopic techniques The primary objective is to compare treatment effectiveness at 2 months postoperatively. Secondary objectives include comparison of complication rates, healing delay, postoperative pain, and recurrence at 1 year, as well as identification of predictive factors for recurrence.

Data will be extracted from medical records and anonymized prior to statistical analysis.

Вмешательства

  • Процедура Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.
    curative treatment of pilonidal sinus, consisting in a wide excision followed by open healing or direct closure of the wound +/- negative pressure therapy dressing. Alterantivelly, an endoscopic procedure to destroy the pilonidal sinus can be performed.

Первичные конечные точки

  • Failure rate [Срок оценки: 2 months after surgery]
Вторичные конечные точки (8)
  • Postoperative complications [Срок оценки: Up to 1 year]
  • Time to complete wound healing [Срок оценки: Up to 1 year]
  • Length of hospital stay [Срок оценки: at hospital discharge]
  • Postoperative pain duration [Срок оценки: Up to 30 days]
  • Postoperative pain Intensity [Срок оценки: Up to 30 days]
  • Analgesic consumption for postoperative pain [Срок оценки: Up to 30 days]
  • Predictive factors for recurrence [Срок оценки: Up to last follow-up]
  • Recurrence rate [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Age < 18 years at time of surgery
  • Surgical treatment for pilonidal sinus disease
  • Surgery performed between January 1, 2015 and March 31, 2025
  • Managed at CHU Angers (Pediatric or Visceral Surgery departments)
  • ICD-10 diagnosis code L05.9
  • CCAM procedure code QBFA007

Критерии исключения

  • Emergency incision and drainage of acute pilonidal abscess (CCAM QBPA001)
  • Initial surgical management performed at another institution
  • Refusal of participation (patient and/or legal guardians, if applicable)
  • Alternative diagnosis (anal abscess, gluteal abscess)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07470294 · 49RC25_0350

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗