TY - JOUR
T1 - Randomized study comparing use of THUNDERBEAT technology vs standard electrosurgery during laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecologic cancer
AU - Fagotti, Anna
AU - Vizzielli, Giuseppe
AU - Fanfani, Francesco
AU - Gallotta, Valerio
AU - Rossitto, Cristiano
AU - Costantini, Barbara
AU - Gueli-Alletti, Salvatore
AU - Avenia, Nicola
AU - Iodice, Raffaella
AU - Scambia, Giovanni
PY - 2014
Y1 - 2014
N2 - 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 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.
AB - 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 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.
KW - Bipolar
KW - Laparoscopy
KW - Lymphadenectomy
KW - Radical hysterectomy
KW - THUNDERBEAT
KW - Ultrasonic
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U2 - 10.1016/j.jmig.2013.12.001
DO - 10.1016/j.jmig.2013.12.001
M3 - Article
C2 - 24325899
AN - SCOPUS:84899629149
VL - 21
SP - 447
EP - 453
JO - Journal of Minimally Invasive Gynecology
JF - Journal of Minimally Invasive Gynecology
SN - 1553-4650
IS - 3
ER -