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Идёт набор NCT04963751

ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling

Без фазы С лечением Enhanced Recovery After Surgery Gynecologic 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: Enhanced Recovery After Surgery (ERAS) Counseling to Patients, Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver.
Кому может быть актуально
Состояния в реестре: Enhanced Recovery After Surgery, Gynecologic Disease. Базовые параметры: 9 лет — 17 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?

Обзор

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Подробное описание

Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population.

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

Вмешательства

  • Другое Enhanced Recovery After Surgery (ERAS) Counseling to Patients
    In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.
  • Другое Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver
    In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the patient's caregiver rather than directly to the patient. It is possible that direct patient involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes.

Первичные конечные точки

  • Numeric Pain rating scores at post-op days 1 and 7 [Срок оценки: 1-7 days after surgery]
Вторичные конечные точки (3)
  • Number of participants who have returned to school at 7-days post-op [Срок оценки: 7 days after surgery]
  • Rate of medication adherence to ERAS-prescribed medications [Срок оценки: 1-7 days after surgery]
  • Rate of narcotic medication prescriptions [Срок оценки: 1-7 days after surgery]

Критерии участия

Критерии включения

  • 9- 17 years of age
  • Patient is undergoing abdominal surgery and being managed under the ERAS protocol

Критерии исключения

  • Developmental delay (IQ < 70) determined by documentation in medical record
  • Emergency or non-elective surgical cases
  • Patients who attend clinic appointments independently from their caregiver

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Pediatric and Gynecology Clinic at Children's Hospital Colorado — Aurora

Идентификаторы

NCT: NCT04963751 · 21-3205

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗