Uterine Manipulation in Surgery for Endometrial Cancer (MAN-U Trial)

N/A

Recruiting

Research Sponsored by Anthony Costales, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be greater than or equal to 18 years old

ECOG performance status 0-2 (see appendix 1)

Must not have

Any prior pelvic irradiation

Planned laparotomic hysterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-operative and up to 30 days post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two groups of women undergoing surgery for early-stage uterine cancer, to see if there is a difference in the rate of cancer cells present in the fluid when a uterine manipulator is used.

Who is the study for?

This trial is for adults over 18 with suspected early stage endometrial cancer, who are fit enough for minimally invasive surgery (MIS) and have no signs of cancer spread outside the uterus. They must be able to follow the study's procedures and not have had pelvic radiation or progesterone therapy for their cancer.

What is being tested?

The study compares outcomes in patients undergoing MIS for early stage uterine cancer using a uterine manipulator (UM) versus those without UM. It aims to see if there's a difference in the presence of cancer cells in surgical fluid between these two methods.

What are the potential side effects?

While specific side effects aren't listed, typical risks associated with minimally invasive gynecologic surgery may include bleeding, infection, injury to surrounding organs, pain, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my pelvic area before.

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I am scheduled for a hysterectomy through an abdominal incision.

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I am on progesterone therapy for my endometrial cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group for reporting.