NCT01717781

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

October 28, 2012

Last Update Submit

November 5, 2012

Conditions

Cervical Cancer

Keywords

operative timelaparoscopyradical hysterectomypelvic lymphadenectomycervical cancerthunderbeat

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Secondary Outcomes (1)

  • Intra- or post operative complications

    24 months

Study Arms (2)

Thunderbeat

EXPERIMENTAL

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

Standard

ACTIVE COMPARATOR

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

Interventions

Thunderbeat technologyPROCEDURE
Thunderbeat
Standard bipolar electrosurgeryPROCEDURE
Standard

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred the Hearth

Rome, Italy, 00100, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente - Policlinico Gemelli, Rome

Study Record Dates

First Submitted

October 28, 2012

First Posted

October 30, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

IT(1)