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

Primary Purpose

Uterine Cervical Neoplasms, Laparoscopic Surgical Procedures

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
3D Laparoscopy
Standard Laparoscopy
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Neoadjuvant Chemoptherapy, Laparoscopy 3D, Cervical cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Catholic University of the Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D Laparoscopy

Standard Laparoscopy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2014
Last Updated
June 5, 2015
Sponsor
Catholic University of the Sacred Heart
Collaborators
Fanfani, Francesco, M.D., Fagotti, Anna, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02320578
Brief Title
2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Fanfani, Francesco, M.D., Fagotti, Anna, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Laparoscopic Surgical Procedures
Keywords
Neoadjuvant Chemoptherapy, Laparoscopy 3D, Cervical cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D Laparoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Laparoscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
3D Laparoscopy
Intervention Description
3D Laparoscopy approach
Intervention Type
Procedure
Intervention Name(s)
Standard Laparoscopy
Intervention Description
Standard laparoscopy approach
Primary Outcome Measure Information:
Title
Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy
Description
Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Number of participants with intra or post operative complications
Description
Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele
Time Frame
two years

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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