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Набор скоро начнётся NCT07468565

Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique (SMILES)

— Наблюдательное Hirschsprung Disease

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: transanal or laparoscopy assisted Swenson coloanal pullthrough.
Кому может быть актуально
Состояния в реестре: Hirschsprung Disease. Базовые параметры: до 16 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

A Bicenter Retrospective Comparative Study of the Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique

Обзор

Hirschsprung disease (HD) is a rare congenital disorder of the enteric nervous system, affecting approximately 1 in 5,000 live births. It is characterized by the absence of ganglion cells in the distal colon, leading to functional intestinal obstruction due to impaired peristalsis. Surgical treatment consists of resection of the aganglionic segment-most commonly rectosigmoid-followed by a colo-rectal, colo-anal, or ileo-anal anastomosis. Among colo-anal pull-through procedures, the Swenson technique was historically performed through an exclusively transanal approach, which carries a risk of sphincter injury correlated with operative duration. More recently, combined laparoscopic and transanal approaches have been developed to reduce this risk, although they may be associated with higher overall complication and reoperation rates. The Swenson procedure can be performed using a single-port laparoscopic approach, a technique that is sparsely described in the literature and rarely practiced in France. Single-port laparoscopy represents an emerging surgical technique that, despite increased technical complexity for surgeons, may further enhance postoperative recovery and cosmetic outcomes compared to conventional multiport laparoscopy. The objective of this study is to describe the outcomes of single-port laparoscopic Swenson pull-through in children with Hirschsprung disease and to compare them with outcomes obtained using more conventional approaches, namely exclusive transanal surgery or combined multiport laparoscopic and transanal approaches.

Вмешательства

  • Процедура transanal or laparoscopy assisted Swenson coloanal pullthrough
    TA-Swenson consist of total trananal endorectal pullthrough after a short submucosal dissection of the last part of the rectum. Laparoscopy-assisted Swenson pull-through consists of laparoscopic mobilization of the aganglionic colon with intraoperative level confirmation, followed by a transanal resection of the aganglionic segment and a primary coloanal anastomosis

Первичные конечные точки

  • To compare the short-term effectiveness of different surgical laparoscopic approaches used for the Swenson technique. [Срок оценки: From surgery to 12 months postoperatively]
Вторичные конечные точки (5)
  • To compare intraoperativensurgical efficiency according to surgical approach [Срок оценки: During surgery (day 0)]
  • To compare immediate postoperative recovery [Срок оценки: At hospital discharge (average 5 days)]
  • Short-term complications [Срок оценки: From hospital discharge to 30 days after surgery]
  • Long-term complications [Срок оценки: From 31 days after surgery up to the last clinical follow-up visit (mean follow-up: 5.5 years)]
  • Long-term continence outcomes [Срок оценки: Assessed after toilet training age (≥3-4 years old) and up to the last clinical follow-up visit (mean follow-up: 5.5 years)]

Критерии участия

Критерии включения

  • Children under 16 years of age
  • Diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination
  • Primary Swenson coloanal pull-through performed at Angers or Caen University Hospital between January 1, 2010 and June 30, 2025

Критерии исключения

  • Parental or legal guardian opposition to the use of medical data for research purposes
  • Hirschsprung disease treated with other surgical techniques (Duhamel, Soave, De La Torre, TERPT)
  • Patients operated on in another hospital
  • Patients who underwent rectosigmoid resection for causes of constipation other than Hirschsprung disease

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: NCT07468565 · 49RC25_0501

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗