A randomized controlled trial on the oncologic outcomes of use of the intrauterine manipulator in the treatment of apparent uterine-confined endometrial carcinoma: the MANEC Trial. in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society / Int J Gynecol Cancer. 2024 Sep 11:ijgc-2024-005668. doi: 10.1136/ijgc-2024-005668.

2024
ASL Città di Torino

Tipo pubblicazione

Journal Article

Autori/Collaboratori (21)Vedi tutti...

Candotti G
Unit of Obstetrics, Gynecology, and Reproductive medicine, IRCCS San Raffaele Hospital, Milan, Italy.
Stevenazzi G
Unit of Obstetrics and Gynecology, Ospedale Nuovo di Legnano - ASST Ovest Milanese, Legnano (Milan), Italy.
Legge F
Unit of Obstetrics and Gynecology, Regional General Hospital 'F. Miulli', Acquaviva (Bari), Italy.

et alii...

Abstract

BACKGROUND: 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. PRIMARY OBJECTIVES: 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. STUDY HYPOTHESIS: 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. TRIAL DESIGN: 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. PRIMARY ENDPOINTS: 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. SAMPLE SIZE: 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. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual completion is expected in 2028, and result presentation in 2032. TRIAL REGISTRATION: ClinicalTrial.gov ID NCT05687084.

Accesso banca dati bibliografica

PMID : 39266205

DOI : 10.1136/ijgc-2024-005668

Keywords

Surgical Procedures, Operative; Hysterectomy; Endometrial Neoplasms;