Full Title
A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial)Purpose
Radical hysterectomy via laparotomy (open surgery) is the standard surgical approach for people with early-stage cervical cancer. A radical hysterectomy involves removal of the uterus, cervix, parametria (tissue beside the cervix), and upper part of the vagina; the ovaries, fallopian tubes, and nearby lymph nodes may also be removed. With laparotomy, the operation is performed through a large incision in the abdomen.
Robotic-assisted laparoscopy is a minimally invasive way to perform radical hysterectomy. The surgeon controls a surgical robot to complete the operation using multiple slender tools inserted into the abdomen through small incisions. Minimally invasive surgery may result in less pain and fewer side effects than open surgery, and it results in shorter hospital stays.
In this study, researchers are comparing robotic-assisted laparoscopy with laparotomy in people undergoing radical hysterectomy for early-stage cervical cancer. They want to see if patients’ disease returns within three years of the surgery. Participants will be randomly assigned to have either laparotomy or robotic-assisted laparoscopy.
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have stage I cervical cancer and be planning to have a radical hysterectomy.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Mario Leitao at 212-639-3987.