Tokyo, Aug. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058761) titled 'Prospective evaluation of preoperative MRI-based uterine volume assessment to predict the feasibility of transvaginal extraction in laparoscopic and robot-assisted hysterectomy' on Aug. 11.
Study Type:
Observational
Primary Sponsor:
Institute - Dokkyo Medical University
Condition:
Condition - Benign uterine tumors (uterine fibroids and adenomyosis)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To prospectively investigate the relationship between preoperative MRI-estimated uterine volume and maximum fibroid diameter, and the need for transvaginal morcellation in laparoscopic or robot-assisted total hysterectomy, and to develop a predictive model for the feasibility of transvaginal extraction.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Female
Key inclusion criteria - 1. Patients scheduled to undergo laparoscopic or robot-assisted total hysterectomy
2. Patients suspected of having uterine fibroids or adenomyosis
3. Patients who have received a full explanation of the study and have provided written informed consent, either personally or via a legal representative
Key exclusion criteria - 1. Patients with malignant disease (including endometrial cancer and atypical endometrial hyperplasia) or suspected malignancy
2. Patients deemed inappropriate for inclusion in this study by the principal investigator or sub-investigators
Target Size - 40
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 07 Month 18 Day
Date of IRB - 2025 Year 07 Month 18 Day
Anticipated trial start date - 2025 Year 08 Month 11 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=R000067189
Disclaimer: Curated by HT Syndication.
