Uccella Stefano, Puppo Andrea, Ghezzi Fabio, Zorzato Pier Carlo, Ceccaroni Marcello, Mandato Vincenzo Dario, Berretta Roberto, Camanni Marco, Seracchioli Renato, Perrone Anna Myriam, Chiantera Vito, Vizzielli Giuseppe, Sozzi Giulio, Beretta Paolo, Steinkasserer Martin, Legge Francesco, Stevenazzi Guido, Candotti Giorgio, Bergamini Valentino, Fanfani Francesco, Garzon Simone
Unit of Obstetrics and Gynecology, Department of Surgery, Dentistry, Pediatrics, and Gynecology, AUOI Verona, University of Verona, Verona, Italy
Unit of Obstetrics and Gynecology, Azienda Ospedaliera Santa Croce e Carle, Cuneo, Italy.
Int J Gynecol Cancer. 2024 Dec 2;34(12):1971-1975. doi: 10.1136/ijgc-2024-005668.
The intrauterine manipulator used during a hysterectomy for endometrial cancer has been suggested as a reason for worsening oncologic outcomes. However, only a few non-randomized retrospective studies have investigated this association.
To compare 4-year recurrence-free survival in the group of patients who undergo hysterectomy using an intrauterine manipulator with that of those who undergo hysterectomy without it.
Patients with endometrial cancer who undergo laparoscopic hysterectomy performed with an intrauterine manipulator would have a lower recurrence-free survival than patients who undergo laparoscopic hysterectomy without a manipulator.
Multicenter, parallel arm, open-label, randomized controlled trial.
MAJOR INCLUSION/EXCLUSION CRITERIA: Adult women diagnosed with apparently uterine-confined endometrial cancer of any histology are eligible. We exclude women who had synchronous or previous (<5 years) invasive cancer, had a WHO performance score >2, and had inadequate baseline organ function.
4-Year recurrence-free survival defined as any relapse or death related to endometrial cancer or treatment calculated from randomization to the date of the first recurrence-free survival event.
With an accrual time of 4 years, a minimum follow-up length of 4 years, and a two-sided type I error of 0.05, we need to enroll 515 women per arm to have a statistical power of 80% to reject the null hypothesis (HR for recurrence=1), assuming that patients who undergo hysterectomy with the use of the intrauterine manipulator have a 3-year recurrence rate of 12.5% and without the use of the intrauterine manipulator of 8.5% (HR for recurrence=1.50), and that 5% of patients are lost at follow-up in each arm, with a median time of 24 months.
Accrual completion is expected in 2028, and result presentation in 2032.
ClinicalTrial.gov ID NCT05687084.
子宫内膜癌子宫切除术中使用的宫内操纵器被认为是导致肿瘤学结局恶化的一个原因。然而，仅有少数非随机回顾性研究对这种关联进行了调查。
比较使用宫内操纵器进行子宫切除术的患者组与未使用宫内操纵器进行子宫切除术的患者组的4年无复发生存率。
使用宫内操纵器进行腹腔镜子宫切除术的子宫内膜癌患者的无复发生存率低于未使用操纵器进行腹腔镜子宫切除术的患者。
多中心、平行组、开放标签、随机对照试验。
主要纳入/排除标准：确诊为任何组织学类型的明显局限于子宫的子宫内膜癌的成年女性符合条件。我们排除有同步或既往（<5年）侵袭性癌症、世界卫生组织体能状态评分>2以及基线器官功能不全的女性。
4年无复发生存率定义为从随机分组到首次无复发生存事件日期计算的任何与子宫内膜癌或治疗相关的复发或死亡。
在4年的入组时间、至少4年的随访时间以及双侧I型错误率为0.05的情况下，我们需要每组招募515名女性，以获得80%的统计效力来拒绝零假设（复发风险比=1），假设使用宫内操纵器进行子宫切除术的患者3年复发率为12.5%，未使用宫内操纵器的患者为8.5%（复发风险比=1.50），且每组有5%的患者在随访中失访，中位随访时间为24个月。
预计2028年完成入组，2032年公布结果。
ClinicalTrial.gov标识符NCT05687084。
