Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
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: SurgPASS - intervention.
- Кому может быть актуально
- Состояния в реестре: Post-operative Complications. Базовые параметры: от 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
- Benin, Ghana, Индия, Nigeria, Rwanda
- 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
SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
Обзор
SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.
Подробное описание
Title: Reducing deaths after surgery in low- and middle-income countries: A pilot cluster randomised trial
Aim: This pilot randomised cluster trial aims to evaluate the feasibility of a large-scale cluster randomised trial to assess the effectiveness and implementation of a pre-operative checklist to reduce deaths after surgery. If this pilot study is successful, we aim to assess the intervention in a separate full-scale cluster randomised trial.
* Objective 1: To determine feasibility and fidelity of delivering the intervention. * Objective 2: To determine the rate recruitment to inform how long it will take to recruit to a future cluster randomised trial. * Objective 3: To obtain information on postoperative outcomes to help inform the outcomes used and sample size of the future cluster randomised trial.
Design: Pilot cluster randomised trial.
Inclusion: Adult (\>18 years old) non-pregnant patients undergoing emergency abdominal surgery with an incision of ≥5cm.
Exclusion: Patients undergoing minimally invasive surgery, or surgery for appendicitis.
Intervention: SurgPASS is an intervention of a preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.
Comparator: Usual care as per local practice at that site.
Follow-up period: 30-days from surgery.
Number of participants: 300 participants: 25 participants in each of 12 clusters (hospitals), from 6 countries.
Outcomes: Since this is a pilot study, there are no pre-specified primary outcomes. However, there are four key outcomes of interest to assess ahead of the main phase randomised clinical trial.
* Outcome 1: Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only) * Outcome 2: Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial) * Outcome 3: Measure 30-day overall complication rates to inform overall sample size of potential full trial
Вмешательства
- Другое SurgPASS - intervention
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
Первичные конечные точки
- Training and checklist completion [Срок оценки: Within 30 days postoperatively]
Критерии участия
Критерии включения
- Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm
- Patient must not be pregnant
- Adults only (greater than or equal to 18 years old)
Критерии исключения
- Minimally invasive surgery
- Surgery for appendicitis
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
Benin · 1 центр
- University of Abomey-Calavi, Abomey-Calavi — Cotonou
Ghana · 1 центр
- Tamale Teaching Hospital, Tamale — Tamale
Индия · 1 центр
- Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008 — Ludhiana
Nigeria · 1 центр
- Lagos University Teaching Hospital (Hub), Lagos — Lagos
Rwanda · 1 центр
- University Teaching Hospital of Kigali (Hub), Kigali — Kigali
Идентификаторы
NCT: NCT06932653 · SurgPASS