A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage Endometrial Cancer: The ROMANHY Trial

Abstract

ObjectiveThis prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer.MethodsIn this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up.ResultsIn the study, 154 patients (76 in arm A and 78 in arm B) were finally included. No significant differences were recorded regarding the baseline characteristics. A statistically significant difference was found in operative time for the laparoscopic staging (p=0.005), while no differences were reported for the robotic procedures (p=0.419). The estimated blood loss was significantly lower in arm A (p=0.030). No statistically significant differences were recorded between the two study groups in terms of peritoneal cytology, LVSI (p=0.501), and pattern of LVSI (p=0.790). No differences were detected in terms of overall survival and disease-free survival (p=0.996 and p=0.480, respectively). Similarly, no differences were recorded in the number of recurrences, 6 (7.9%) in arm A and 4 (5.2%) in arm B (p=0.486). The use of the uterine manipulator had no impact on DFS both at univariable and multivariable analyses.ConclusionsThe intrauterine manipulator does not affect the LVSI in early-stage endometrial cancer patients undergoing laparoscopic/robotic staging.Clinical Trial Registrationhttps://clinicaltrials.gov, identifier (NCT: 02762214)

Prospective Multicenter Trial Assessing the Impact of Positive Peritoneal Cytology Conversion on Oncological Outcome in Patients with Endometrial Cancer Undergoing Minimally Invasive Surgery with the use of an Intrauterine Manipulator

“…Furthermore, the majority of the studies investigated only one additional peritoneal washing after insertion of the uterine manipulator. 15 , 16 , 41 In our population, 80% of the converted cytologies were found only at the end of the surgery, suggesting that the issue is not mainly the insertion of the manipulator but rather the manipulation during the whole procedure. The only further study investigating three sets of peritoneal washings to date, by Lim et al, found two converting positive cytologies in 46 patients, one postmanipulator and one posthysterectomy—corresponding to a conversion rate of 4.3%.…”

“…While the association of positive peritoneal cytology with decreased survival has been shown by multiple studies, 26 – 30 no study has explored the impact of cytology conversion on oncological outcome in endometrial cancer to date. On the other hand, several studies investigating the impact of intrauterine manipulators on oncological outcomes revealed no significant association, 15 – 18 , 42 , 43 except for the largest study by Padilla et al 20 This might be due to the generally low risk of recurrence in endometrial cancer, making larger sample sizes necessary to detect significant differences. Nevertheless, in some of the above-mentioned studies, there was a trend toward worse oncological outcomes with the use of intrauterine manipulators, although not statistically significant.…”

Minimally invasive surgery in gynecological cancers: update and systematic review

“…Fifty-eight studies were considered eligible for the study, 23 studies regarding MIS in endometrial cancer (Table 1, Ref. [4,5,7,17,20,23,[25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]), 19 studies on MIS in ovarian cancer (Table 2, Ref. [42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60]), and 16 studies regarding MIS in cervical cancer (Table 3, Ref.…”

“…A recent prospective randomized clinical trial (RO-MANHY trial) investigated the influence of the use of intrauterine manipulators (IUM) on lymphovascular space invasion (LVSI) status and peritoneal cytology. However, no difference was found between the two groups with no adverse impact of IUM on OS and disease free survival (DFS) [31].…”

“…Furthermore, laparoscopy is associated with reduced operative morbidity and hospital stay. Gueli Alletti, 2021 [31] Randomized trial Endometrial cancer 154 The intrauterine manipulator does not affect the LVSI in early-stage endometrial cancer patients undergoing laparoscopic/robotic staging. Scaletta, 2019 [41] Systematic review Endometrial cancer 16425 MIS appears to be safe in the management of high-risk EC patients, showing better perioperative and postoperative outcomes and comparable oncological outcomes than open surgery.…”