Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery with UM, Surgery without UM.
- Who it may be relevant to
- Registry conditions: ENDOMETRIAL CANCER. Basic parameters: 18 years — 90 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
Detailed description
In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix).
Even though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.
Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.
The purpose of this study is to see if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.
Researchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.
Interventions
- Device Surgery with UM
The experimental group will have MIS with the placement of a uterine manipulator - Device Surgery without UM
The control group will have MIS without the placement of a uterine manipulator
Primary outcome measures
- Positive peritoneal cytology (PC) [Time frame: Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group]
Secondary outcome measures (6)
- Post-operative positive PC [Time frame: Immediately after closure of the vaginal cuff]
- Lymphovascular space invasion (LVSI) [Time frame: During surgery]
- Percentage of myometrial invasion (MI) [Time frame: During surgery]
- Extent of lymph node metastases [Time frame: During surgery]
- Operative time [Time frame: 1 day]
- Surgical morbidity [Time frame: Intra-operative and up to 30 days post-surgery]
Eligibility criteria
Inclusion criteria
A subject will be considered eligible for inclusion in this study if all the following criteria are met:
- Patient must be greater than or equal to 18 years old.
- Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
- Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
- CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).
6\. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.
Exclusion criteria
A subject must not have any of the following criteria:
- Planned laparotomic hysterectomy
- On progesterone therapy to treat their endometrial cancer
- Any prior pelvic irradiation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Cleveland Clinic — Cleveland
- Baylor College of Medicine- McNair Campus — Houston
- Baylor College of Medicine — Houston
- Ben Taub General Hospital — Houston
- Harris Health System - Smith Clinic — Houston
Identifiers
NCT: NCT04586959 · H-46373