Prospective evaluation of preoperative MRI-based uterine volume assessment to predict the feasibility of transvaginal extraction in laparoscopic and robot-assisted hysterectomy

Prospective evaluation of preoperative MRI-based uterine volume assessment to predict the feasibility of transvaginal extraction in laparoscopic and robot-assisted hysterectomy - Prospective research on preoperative volume assessment by MRI for evaluating transvaginal extraction feasibility in minimally invasive hysterectomy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058761

Enrollment

Registered

2025-08-11

Start date

2025-08-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign uterine tumors (uterine fibroids and adenomyosis)

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Cut-off values of preoperative MRI-estimated uterine volume and maximum fibroid diameter for predicting the feasibility of extraction without transvaginal morcellation, determined by ROC curve analysis.	—

Secondary

Measure	Time frame
1. Correlation between MRI-estimated uterine volume and actual uterine weight (Pearson's correlation coefficient) 2. Comparison of uterine volume, weight, and maximum fibroid diameter between cases with and without transvaginal morcellation 3. Association between history of vaginal delivery and the performance of transvaginal morcellation 4. Cut-off values of uterine volume and maximum fibroid diameter for extraction without morcellation stratified by history of vaginal delivery 5. Factors associated with extraction without morcellation (history of vaginal delivery, BMI, MRI-estimated uterine volume) analyzed by logistic regression 6. Correlation between MRI-estimated uterine volume and operative time/blood loss	—

Measure

Time frame

1. Correlation between MRI-estimated uterine volume and actual uterine weight (Pearson's correlation coefficient) 2. Comparison of uterine volume, weight, and maximum fibroid diameter between cases with and without transvaginal morcellation 3. Association between history of vaginal delivery and the performance of transvaginal morcellation 4. Cut-off values of uterine volume and maximum fibroid diameter for extraction without morcellation stratified by history of vaginal delivery 5. Factors associated with extraction without morcellation (history of vaginal delivery, BMI, MRI-estimated uterine volume) analyzed by logistic regression 6. Correlation between MRI-estimated uterine volume and operative time/blood loss

—

Countries

Japan

Contacts

Public ContactYoshimasa Kawarai

Dokkyo Medical University Obstetrics and Gynecology

y-kawarai@dokkyomed.ac.jp+81-282-87-2166

Outcome results