Study Overview
This study looks at how using an intrauterine manipulator during a hysterectomy for endometrial cancer affects patient outcomes. Previous studies have suggested that this tool might lead to worse results, but more research is needed.
Key Objectives
The main goal is to compare the 4-year recurrence-free survival rates between two groups of patients: those who had a hysterectomy with the manipulator and those who did not.
Hypothesis
We believe that patients who have a laparoscopic hysterectomy with the manipulator will have a lower chance of being cancer-free after four years compared to those without it.
Study Design
This is a multicenter, randomized controlled trial, meaning it will take place at multiple locations and participants will be randomly assigned to one of the two groups.
Who Can Participate?
Women diagnosed with early-stage endometrial cancer can join the study. However, those with recent invasive cancers or poor health conditions are excluded.
What We Are Measuring
The primary outcome we are looking at is the rate of patients who remain cancer-free for four years after their surgery.
Sample Size
To ensure reliable results, we aim to enroll 515 women in each group over four years, expecting to follow them for at least four years.
Timeline
We expect to finish enrolling participants by 2028 and to present our results by 2032.
Next Steps for Clinics and Patients
Define Measurable Outcomes
Set clear goals based on the trial data to improve patient care and outcomes.
Select AI Tools
Choose AI solutions that meet specific clinical needs to enhance treatment and monitoring.
Implement Gradually
Start with a pilot project to track results and expand based on findings from the trial.
Contact Us for AI Solutions
If you’re interested in AI solutions for medical management, reach out to us:
Telegram: https://t.me/itinai
LinkedIn: https://www.linkedin.com/company/itinai/
