Thunder Cervix: Thunderbeat Technology vs Standard Bipolar Electro Surgery in Laparoscopic Radical Hysterectomy and Pelvic Lymphadenectomy for Cervical Cancer

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Unknown status

CT.gov ID

NCT01717781

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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 with complete clinical response could be 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 .

Secondary endpoints of this comparison are incidence of intra- or postoperative complications, estimated blood loss, postoperative pain, days of hospitalization and costs for the health care system.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Procedure: Thunderbeat technology Procedure: Standard bipolar electrosurgery	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<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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thunderbeat Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with Thunderbeat technology: using Thunderbeat technique, surgeons can avoid changing instruments during surgery since Thunderbeat combines bipolar energy for haemostasis and ultrasound for dissection and cut. Thunderbeat is used to divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to incise the bladder peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to dissect the bladder and develop rectovaginal septum, to unroof the ureter, to cut parametria, and to divide the uterosacral ligaments. Monopolar hook is used in the culdotomy. Thunderbeat is also used to perform pelvic lymphadenectomy.	Procedure: Thunderbeat technology
Active Comparator: Standard Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery. 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 bipolar electrosurgery

Arm

Intervention/Treatment

Experimental: Thunderbeat

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with Thunderbeat technology: using Thunderbeat technique, surgeons can avoid changing instruments during surgery since Thunderbeat combines bipolar energy for haemostasis and ultrasound for dissection and cut. Thunderbeat is used to divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to incise the bladder peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to dissect the bladder and develop rectovaginal septum, to unroof the ureter, to cut parametria, and to divide the uterosacral ligaments. Monopolar hook is used in the culdotomy. Thunderbeat is also used to perform pelvic lymphadenectomy.

Procedure: Thunderbeat technology

Active Comparator: Standard

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery. 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 bipolar electrosurgery

Outcome Measures

Primary Outcome Measures

Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy [24 months]
Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.

Secondary Outcome Measures

Intra- or post operative complications [24 months]
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:

Inclusion/exclusion 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 For diseases
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 Sacred the Hearth	Rome		Italy	00100

Sponsors and Collaborators

Catholic University of the Sacred Heart

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 - Policlinico Gemelli, Rome, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01717781

Other Study ID Numbers:

Thunder Cervix

First Posted:

Oct 30, 2012

Last Update Posted:

Nov 6, 2012

Last Verified:

Nov 1, 2012

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

operative time

laparoscopy

radical hysterectomy

pelvic lymphadenectomy

cervical cancer

thunderbeat

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Nov 6, 2012