A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

Summary

Objectives

This is a multi-center, open-label, randomized, non-inferiority clinical trial with the
hypothesis that robotically assisted hysterectomy with tumor containment prior to
colpotomy is non-inferior to abdominal 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 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 or simple 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 or simple 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)