Факторы риска осложнений после краниопластики
Проспективное исследование по выявлению факторов риска осложнений после краниопластики
Cranial defects often result from brain injuries, hemorrhages, strokes, or brain tumors. These conditions can increase pressure inside the skull, and if left untreated, may lead to dangerous complications like brain herniation. To manage this, a common procedure called decompressive craniectomy is performed to reduce intracranial pressure. While this surgery often stabilizes the patient's condition, it leaves a cranial defect that exposes the brain to external risks, including pressure fluctuations and potential damage. In severe cases, patients with larger defects may develop complications such as sinking skin flap syndrome.
Cranial reconstruction, also known as cranioplasty, is an important procedure to restore the skull's structure and protect the brain. This surgery can improve brain function, stabilize intracranial pressure, and enhance the patient's appearance. While cranioplasty is a standard neurosurgical procedure, it has a relatively high risk of complications compared to other brain surgeries. Common complications include infections, bleeding, hydrocephalus, and seizures. In severe cases, complications may lead to the failure of the reconstruction.
Understanding the factors that contribute to complications after cranioplasty is crucial for neurosurgeons to improve outcomes and reduce risks. This study aims to identify these factors and develop predictive models for postoperative complications of cranioplasty.
Обзор исследования
Статус
Подробное описание
Cranial defects, often caused by conditions such as traumatic brain injuries, strokes, or brain tumors, present a significant clinical challenge. Decompressive craniectomy, frequently performed to manage increased intracranial pressure, leaves patients with cranial defects that require subsequent cranioplasty. Cranioplasty, while being a common neurosurgical procedure, has a higher complication rate compared to other cranial surgeries, warranting a deeper investigation into its risk factors.
In addition to identifying risk factors, this study aims to develop and validate predictive models for postoperative complications. Advanced statistical techniques, such as machine learning algorithms, will be used to assess the contribution of individual variables to complication risk.
By leveraging a large multi-center dataset, the study seeks to provide actionable insights into the prevention of postoperative complications. The results are expected to inform clinical decision-making, enhance patient outcomes, and improve the quality of perioperative care in neurosurgical practice.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Китай, 400042
- Department of Neurosurgery, Daping Hospital of Army Medical University
-
-
Shaanxi
-
Xi'an, Shaanxi, Китай, 710038
- Department of Neurosurgery, Tang-Du Hospital
-
-
Shandong
-
Jinan, Shandong, Китай, 250012
- Department of Neurosurgery, Qilu Hospital of Shandong University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Patients with cranial defects who underwent their first cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University between January 1, 2015, and January 1, 2025, or at Tangdu Hospital of Air Force Medical University or Daping Hospital of the Army Medical University between January 1, 2015, and July 31, 2023.
Описание
Inclusion Criteria:
- Patients who underwent cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Medical University, or Daping Hospital, Army Military Medical University between January 1, 2015, and July 31, 2023
- Diagnosed with cranial defects
- Possessed complete and accessible electronic medical records
- Patients had no prior history of cranioplasty
Exclusion Criteria:
- Patients with a prior history of cranioplasty
- Severe comorbidities (such as serious cardiac, liver, kidney and immune system dysfunction)
- Congenital cranial defects
- Severe missing data
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: RETROSPECTIVE
Когорты и вмешательства
Группа / когорта |
|---|
|
Derivation Cohort
Identification of risk factors, development and internal validation of predictive models |
|
External Validation Cohort
External validation of the predictive models |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Risk factors for postoperative complications of cranioplasty
Временное ограничение: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.
|
The primary outcome is to identify factors associated with postoperative complications of cranioplasty. The analysis will focus on patient demographics, comorbidities, surgical details, and other clinical variables extracted from medical records |
From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Establishment predictive models for postoperative complications of cranioplasty
Временное ограничение: From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.
|
The secondary outcome is to develop and validate predictive models for postoperative complications of cranioplasty based on identified risk factors. |
From the date of cranioplasty to the date of hospital discharge, with complications assessed throughout the hospitalization period, up to 60 days.
|
Соавторы и исследователи
Следователи
- Главный следователь: Ning Yang, M.D., Ph.D, Department of Neurosurgery, Qilu Hospital of Shandong University
Публикации и полезные ссылки
Общие публикации
- Malcolm JG, Rindler RS, Chu JK, Grossberg JA, Pradilla G, Ahmad FU. Complications following cranioplasty and relationship to timing: A systematic review and meta-analysis. J Clin Neurosci. 2016 Nov;33:39-51. doi: 10.1016/j.jocn.2016.04.017. Epub 2016 Aug 4.
- Bader ER, Kobets AJ, Ammar A, Goodrich JT. Factors predicting complications following cranioplasty. J Craniomaxillofac Surg. 2022 Feb;50(2):134-139. doi: 10.1016/j.jcms.2021.08.001. Epub 2021 Aug 25.
- Chaturvedi J, Botta R, Prabhuraj AR, Shukla D, Bhat DI, Devi BI. Complications of cranioplasty after decompressive craniectomy for traumatic brain injury. Br J Neurosurg. 2016;30(2):264-8. doi: 10.3109/02688697.2015.1054356. Epub 2015 Jun 17.
- Zanaty M, Chalouhi N, Starke RM, Clark SW, Bovenzi CD, Saigh M, Schwartz E, Kunkel ES, Efthimiadis-Budike AS, Jabbour P, Dalyai R, Rosenwasser RH, Tjoumakaris SI. Complications following cranioplasty: incidence and predictors in 348 cases. J Neurosurg. 2015 Jul;123(1):182-8. doi: 10.3171/2014.9.JNS14405. Epub 2015 Mar 13.
- Belzberg M, Mitchell KA, Ben-Shalom N, Asemota AO, Wolff AY, Santiago GF, Shay T, Huang J, Manson PN, Brem H, Gordon CR. Cranioplasty Outcomes From 500 Consecutive Neuroplastic Surgery Patients. J Craniofac Surg. 2022 Sep 1;33(6):1648-1654. doi: 10.1097/SCS.0000000000008546. Epub 2022 Mar 4.
- Singh S, Singh R, Jain K, Walia B. Cranioplasty following decompressive craniectomy - Analysis of complication rates and neurological outcomes: A single center study. Surg Neurol Int. 2019 Jul 19;10:142. doi: 10.25259/SNI_29_2019. eCollection 2019.
- Honeybul S, Ho KM. Long-term complications of decompressive craniectomy for head injury. J Neurotrauma. 2011 Jun;28(6):929-35. doi: 10.1089/neu.2010.1612. Epub 2011 Jun 1.
- Henry J, Amoo M, Murphy A, O'Brien DP. Complications of cranioplasty following decompressive craniectomy for traumatic brain injury: systematic review and meta-analysis. Acta Neurochir (Wien). 2021 May;163(5):1423-1435. doi: 10.1007/s00701-021-04809-z. Epub 2021 Mar 23.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KYLL-202407-041
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
All collected IPD
Сроки обмена IPD
Beginning 1 year after publication with no end date
Критерии совместного доступа к IPD
The individual participant data (IPD) and supporting information are available from the corresponding author upon reasonable request via email. Access will be provided to researchers with a scientifically sound proposal and for non-commercial purposes, in compliance with ethical guidelines.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .