2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT02320578

Collaborator

Fanfani, Francesco, M.D. (Other), Fagotti, Anna, M.D. (Other)

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this prospective randomized pilot study is to verify if the operative time of a Radical abdominal hysterectomy (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 3D Laparoscopy (Olympus Medical Systems Corp) versus standard laparoscopy

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasms Laparoscopic Surgical Procedures	Procedure: 3D Laparoscopy Procedure: Standard Laparoscopy	N/A

Detailed Description

Radical abdominal hysterectomy (RAH) with pelvic lymphadenectomy is the standard surgical treatment for early stage cervical carcinoma FIGO stages IA2-IB1-IIA<2cm. 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.

This prospective randomized pilot study is aimed 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 3D Laparoscopy (Olympus Medical Systems Corp) vs. standard laparoscopy.

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 endopoints of this comparison are incidence of intra- or postoperative complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele), estimated blood loss, days of hospitalization and costs for the health care system.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Prospective Randomized Trial on2D Versus 3D 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.

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D 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.	Procedure: 3D Laparoscopy 3D Laparoscopy approach
Active Comparator: Standard Laparoscopy 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.	Procedure: Standard Laparoscopy Standard laparoscopy approach

Arm

Intervention/Treatment

Experimental: 3D 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.

Procedure: 3D Laparoscopy

3D Laparoscopy approach

Active Comparator: Standard Laparoscopy

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.

Procedure: Standard Laparoscopy

Standard laparoscopy approach

Outcome Measures

Primary Outcome Measures

Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy [Intraoperative]
Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses

Secondary Outcome Measures

Number of participants with intra or post operative complications [two years]
Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of the Sacred Heart	Rome		Italy	00168

Sponsors and Collaborators

Catholic University of the Sacred Heart
Fanfani, Francesco, M.D.
Fagotti, Anna, M.D.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Giovanni Scambia, Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT02320578

Other Study ID Numbers:

3D vs 2D Cervix

First Posted:

Dec 19, 2014

Last Update Posted:

Jun 8, 2015

Last Verified:

Jun 1, 2015

Keywords provided by Prof. Giovanni Scambia, Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente, Catholic University of the Sacred Heart

Neoadjuvant Chemoptherapy

Laparoscopy 3D

Cervical cancer

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jun 8, 2015