2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial
Uterine Cervical Neoplasms, Laparoscopic Surgical Procedures
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Neoadjuvant Chemoptherapy, Laparoscopy 3D, Cervical cancer
Eligibility Criteria
- Age ≤ 75 years
- Patient's informed consent
- American Society of Anesthesiologists: < class III or IV
- No actual pregnancies or P.I.D.
- No previous major abdominal surgical procedures
- Early stage cervical cancer (FIGO stages IA2-IB1-IIA<2cm) and advanced stage cervical cancer (FIGO stages IB2-IIA>2cm-IIB) submitted to NACT with complete clinical response
- No previous radiotherapy on the pelvic field
- No uterine size larger than conform 10 weeks gestation
Sites / Locations
- Catholic University of the Sacred Heart
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
3D Laparoscopy
Standard Laparoscopy
Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with 3D Laparoscopic technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition 3D telescope. Two additional 5 mm ports are placed under direct visualization. One more 5- mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.
Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard laparoscopy technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope. Two additional 5 mm ports are placed under direct visualization. One more 5 mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.