Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060882) titled 'A Study on the Effect of Introducing PEG Gel Dural Sealant for Preventing Postoperative Cerebrospinal Fluid Leakage in Patients Who Underwent Dural Repair During Spinal Surgery' on March 21.
Study Type:
Observational
Primary Sponsor:
Institute - Japan Community Healthcare Organization Osaka Hospital
Condition:
Condition - Incidental or intentional durotomy requiring dural repair during spinal surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To determine whether the introduction of a synthetic PEG dural sealant contributes to reducing postoperative CSF leakage and associated symptoms, thereby optimizing dural repair strategies and improving patient outcomes.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who underwent spinal surgery (cervical, thoracic, or lumbar) and required intraoperative dural repair.
This includes cases in which an incidental durotomy occurred and required repair, as well as cases in which intentional durotomy (e.g., for intradural tumors) was performed and subsequently repaired.
Key exclusion criteria - Cases with preoperative cerebrospinal fluid (CSF) leakage (e.g., traumatic CSF leakage).
Cases judged to be inappropriate for inclusion by the principal investigator.
Patients who declined participation in the study (opt-out).
Target Size - 130
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 03 Day
Date of IRB - 2026 Year 03 Month 05 Day
Anticipated trial start date - 2026 Year 03 Month 05 Day
Last follow-up date - 2031 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069650
Disclaimer: Curated by HT Syndication.
