Trials · 2022
The effect of postoperative early lumbar drainage on delayed fever after cerebellopontine angle tumour surgery: study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Zhang Yunze, Wu Yingxi, Wu Yang, Zhu Gang, Xue Yafei, Qu Yan, Zhao Tianzhi
Аннотация
BACKGROUND: Postoperative fever is one of the common complications in neurosurgery, and intracranial aseptic inflammation and infection are important risk factors. Continuous drainage of cerebrospinal fluid (CSF) via lumbar drainage (LD) is often used in the treatment of postoperative intracranial infection or aseptic inflammation. Compared with the previously reported placement of LD after the onset of meningitis symptoms, we designed this randomized controlled trial (RCT) to evaluate the effectiveness and safety of early drainage (1st day postoperation) of CSF using the preset lumbar cistern to prevent delayed fever (fever occurred after the third day postoperation) or reduce its treatment time after cerebellopontine angle (CPA) tumour surgery.
METHODS: Patients suffering from CPA tumours and who underwent resection of the tumour with an intraoperative dura opening time > 4 h are recruited for this study. The study is a 2-arm RCT to compare the early LD group and the no early LD group. Postoperative duration and rate of delayed fever and postoperative length of stay (LOS), as the main outcomes, will be compared in the two groups.
DISCUSSION: Here, we present the study design of a prospective RCT to evaluate the safety and efficacy of using preoperative preset LD to treat or reduce postoperative delayed fever.
TRIAL REGISTRATION: China Clinical Trial Registry ChiCTR2100049057. Registered on July 20, 2021.
METHODS: Patients suffering from CPA tumours and who underwent resection of the tumour with an intraoperative dura opening time > 4 h are recruited for this study. The study is a 2-arm RCT to compare the early LD group and the no early LD group. Postoperative duration and rate of delayed fever and postoperative length of stay (LOS), as the main outcomes, will be compared in the two groups.
DISCUSSION: Here, we present the study design of a prospective RCT to evaluate the safety and efficacy of using preoperative preset LD to treat or reduce postoperative delayed fever.
TRIAL REGISTRATION: China Clinical Trial Registry ChiCTR2100049057. Registered on July 20, 2021.