Tokyo, May 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061647) titled 'A prospective study of the relationship between drain position and postoperative hematoma and decompression status after full-endoscopic lumbar decompression' on May 21.

Study Type: Observational

Primary Sponsor: Institute - Japan Community Healthcare Organization Osaka Hospital

Condition: Condition - lumbar spinal canal stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify whether drain tip position assessed by CT 1-2 days after full-endoscopic unilateral laminotomy for bilateral decompression is associated with the amount and severity of postoperative epidural hematoma/fluid collection and decompression parameters assessed by MRI 3-4 days postoperatively, thereby informing optimization of postoperative management. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be included. 1. Patients undergoing full-endoscopic unilateral laminotomy for bilateral decompression for lumbar spinal canal stenosis, mainly degenerative disease, at our institution. 2. Age at surgery 20 years or older. 3. Patients undergoing CT at 1-2 days postoperatively, MRI at 3-4 days postoperatively, and MRI at 6 months postoperatively according to the clinical pathway at our institution. Key exclusion criteria - Patients meeting any of the following criteria will be excluded. 1. Patients whose main pathology is other than lumbar spinal canal stenosis, such as tumor, infection, trauma, or inflammatory disease. 2. Patients undergoing concomitant fusion or instrumentation. 3. Patients who cannot undergo postoperative MRI because of contraindications or other reasons. 4. Patients who refuse participation in the study through the opt-out process. 5. Patients judged by the principal investigator to be unsuitable for the study, such as cases in which imaging evaluation is technically difficult. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 10 Day Date of IRB - 2026 Year 05 Month 21 Day Anticipated trial start date - 2026 Year 05 Month 21 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070391

Disclaimer: Curated by HT Syndication.