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Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer

NCT01717794 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-11-06

No results posted yet for this study

Summary

This prospective randomized pilot study is aimed to verify if the operative time of a TLH with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II 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 (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.

Conditions

Interventions

PROCEDURE

Thunderbeat technology

PROCEDURE

Standard bipolar electrosurgery

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01717794 on ClinicalTrials.gov