The purpose of this study is to investigate if
minimally invasive surgery, called robotic assisted laparoscopy (small incision
surgery), is worse than open surgery (otherwise known as a laparotomy) when
performing a radical hysterectomy for cervical cancer. A radical hysterectomy
is surgery to remove the uterus, cervix, the parametria (tissue beside the
cervix) and the upper part of the vagina; the ovaries, fallopian tubes, and
nearby lymph nodes may also be removed. This is the surgical procedure required
for the treatment of early-stage cervical cancer.
This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted radical hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal radical hysterectomy with respect to disease free survival.
At the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the radical hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted.
Standard arm: Radical hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device).
Study arm: Radical hysterectomy is performed as per standard robotic technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)