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Retrospective data suggest that parametrial infiltration is low in patients with early-stage low-risk cervical cancer, and that simple hysterectomy may be adequate for treatment.This multicenter (130 centers, 12 countries, December 2012 to November 2019) noninferiority trial randomized 700 females (350 in each group) to either radical hysterectomy or simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions measuring 2 cm or smaller with limited stromal invasion).The primary outcome was pelvic recurrence at 3 yr after surgery.A prespecified noninferiority margin of 4 percentage points was used.Most subjects had low-risk tumors (91.7% stage IB1 by the 2009 International Federation of Gynecology and Obstetrics criteria) with squamous-cell histology (61.7%) and were grade 1 or 2 (59.3%).There was no difference in the primary outcome at a median follow-up time 4.5 yr (2.17% radical vs. 2.52% simple; absolute difference, 0.35 percentage points; 90% CI, -1.62 to 2.32) by intent to treat.Similar results were noted per protocol.With regard to safety outcomes, less urinary incontinence within and beyond 4 weeks of surgery or urinary retention (similar time frame) was noted in the simple hysterectomy group (2.4% vs. 5.5%; P = 0.048; 4.7% vs. 11.0%;P = 0.003; 0.6% vs. 11.0%;P < 0.001; 0.6% vs. 9.9%; P < 0.001, respectively).(Article Selection: Martin J. London, M.D.
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