Tokyo, Feb. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060724) titled 'Comparison of Postoperative ICU and Ward Management After Free Flap Reconstruction: A Single-Center Retrospective Study of Re-exploration Rates' on Feb. 21.
Study Type:
Observational
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - Head and neck diseases
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to examine whether postoperative management setting (intensive care unit versus ward) is associated with re-exploration within 30 days after free flap reconstruction in a single-center retrospective cohort.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients who underwent free flap reconstruction for oral and maxillofacial defects at our institution during the study period
2. Patients aged 18 years or older at the time of anesthesia consent
3. Surgery performed under general anesthesia
4. Availability of postoperative follow-up data for at least 30 days in the medical records
Key exclusion criteria - 1. Cases in which the postoperative management setting (ICU or ward) could not be identified
2. Cases with missing data required to assess the primary outcome (re-exploration within 30 days)
Target Size - 300
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 10 Month 01 Day
Date of IRB - 2025 Year 12 Month 17 Day
Anticipated trial start date - 2025 Year 12 Month 17 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069473
Disclaimer: Curated by HT Syndication.
