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Randomized study comparing use of THUNDERBEAT technology vs standard electrosurgery during laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecologic cancer . STUDY OBJECTIVE To compare operative time with use of THUNDERBEAT ( TB ) vs standard electrosurgery ( SES ) during laparoscopic radical hysterectomy and pelvic lymphadenectomy to treat gynecologic tumors . DESIGN Evidence obtained from a properly designed , randomized , controlled trial ( Canadian Task Force classification I ) . SETTING Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome , Italy . PATIENTS Fifty patients with early cervical cancer ( FIGO stages IA2 , IB1 , IIA < 2 cm ) or locally advanced cervical cancer ( FIGO stages IB2 , IIA > 2cm , IIB ) who received neoadjuvant treatment ( chemotherapy or radiochemotherapy ) and demonstrated a complete or partial clinical response and early stage endometrioid endometrial cancer ( FIGO stages IB , II ) were randomly assigned to undergo TB ( arm A ) or SES ( arm B ) . INTERVENTION Laparoscopic radical hysterectomy with bilateral pelvic lymphadenectomy , using an easily reproducible technique was performed . MEASUREMENTS AND MAIN RESULTS Fifty patients were available for analysis , with 25 women randomly assigned to TB ( arm A ) and 25 to SES ( arm B ) . The median operative time was 85 minutes for TB vs 115 minutes for SES ( p = .001 ) . At multivariate analysis , endometrial cancer ( p = .001 ) and TB ( p = .001 ) were independently associated with shorter operating time . No differences in perioperative outcomes and postoperative complications were observed between the 2 arms . Patients who underwent TB reported less postoperative pain , both at rest ( p = .005 ) and after the Valsalva maneuver ( p = .008 ) , with less additional analgesic therapy other than standard therapy required in patients who underwent SES ( p = .02 ) . CONCLUSION TB is associated with shorter operative time and less postoperative pain than is the standard technique ( SES ) in patients with uterine cancer .
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Intervention_Surgical
THUNDERBEAT
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Intervention_Surgical
standard electrosurgery
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Intervention_Physical
neoadjuvant treatment (
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Intervention_Pharmacological
chemotherapy
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Intervention_Physical
or radiochemotherapy )
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Intervention_Surgical
Laparoscopic radical hysterectomy with bilateral pelvic lymphadenectomy
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Outcome_Other
median operative time
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Outcome_Other
shorter operating time .
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Outcome_Adverse-effects
perioperative outcomes and postoperative complications
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Outcome_Pain
postoperative pain
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Outcome_Other
operative time
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Outcome_Pain
postoperative pain
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Participant_Condition
gynecologic cancer
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Participant_Condition
gynecologic tumors .
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Participant_Sample-size
Fifty
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Participant_Condition
cervical cancer
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Participant_Condition
cervical cancer
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Participant_Sample-size
Fifty
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Participant_Sample-size
25
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Participant_Sex
women
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Participant_Condition
uterine cancer