Prospective Randomized Trial on Laparoscopic Radical Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Early Stage Cervical Cancer (FIGO Stages IA2-IB1-IIA<2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA>2 Cm-IIB) Submitted to NACT With Complete Clinical Response: Thunderbeat Technology Versus Standard Bipolar Electro Surgery
Radical abdominal hysterectomy (RAH) with pelvic lymphadenectomy is the standard surgical
treatment for early stage cervical carcinoma FIGO stages IA2-IB1-IIA<2cm1. Since the early
90's laparoscopic radical hysterectomy with pelvic lymphadenectomy (LRH) has been suggested
as surgical approach for the treatment of cervical cancer. In the recent years, many
institutions have begun to consider it an attractive technique and to study its feasibility
and safety. Most of these studies have shown that LRH is relatively more time-consuming than
standard laparotomy and ranges from 90 to 420 minutes according to surgeons' experience and
different techniques adopted to achieve hemostasis, resect the parametrium and uterosacrals.
Spirtos et al. demonstrated that staplers could reduce mean operation time from 253 to 205
minutes if compared to argon beam coagulator. Moreover, the pulsed bipolar system was
associated with significant reduction in operative time in comparison with the conventional
bipolar system (mean, 172 minutes vs 229 minutes; P < 0.001). The largest series of LRH
reported from a single institution by Puntambekar et al included 248 patients and described
the "Pune technique" (anterior and posterior peritoneal U cuts, early dissection of the
rectovaginal space, fully mobilization of the uterus, resection of the cardinal and
uterosacral ligaments with Ligasure system (Ligasure Vessel Sealing System; Valleylab, Tyco
Healthcare, Boulder, CO)), obtaining a very short mean operative time (mean, 92 minutes;
range 6-120 minutes).
A recent review on laparoscopic and robot-assisted radical hysterectomy with pelvic
lymphadenectomy including 17 studies reported a mean operating time of 202 minutes [range,
184-221 minutes] in the group of LRH, which matches with our experience of 210 min (range
180-240), using conventional bipolar electrosurgery.
The aim of this pilot RCT is to verify if the operative time of a LRH with pelvic
lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and for
advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to neoadjuvant
chemotherapy (NACT) with complete clinical response could be further reduced using
Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and
bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .
Saving operative time would mean shorter anesthesia and faster recovery, further improving
the safety profile of the laparoscopic approach in the treatment of cervical cancer.
Secondary endpoints of this comparison are incidence of intra- or postoperative
complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or
other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS),
days of hospitalization and costs for the health care system.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy
Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.
Italy: Ethics Committee, Catholic University of the Sacred Hearth