SHAPE: simple versus radical hysterectomy in low-risk early cervical cancer
For small, low-risk cervical cancers, a simple hysterectomy gave the same very low pelvic recurrence rate as a radical hysterectomy with fewer urinary and sexual complications, so less extensive surgery is now acceptable.
Overview
Phase 3 non-inferiority trial of 700 women with low-risk cervical cancer (up to 2 cm, limited stromal invasion) randomised to simple hysterectomy or radical hysterectomy, both with pelvic node assessment.
Three-year pelvic recurrence was 2.52 percent with simple hysterectomy and 2.17 percent with radical hysterectomy, within the non-inferiority margin, with fewer urinary incontinence and retention problems and better sexual health after simple hysterectomy.
- Three-year pelvic recurrence 2.52 percent vs 2.17 percent (non-inferior).
- Urinary incontinence 2.4 percent vs 5.5 percent within four weeks; urinary retention 0.6 percent vs 11.0 percent.
Women with low-risk early cervical cancer can be offered simple hysterectomy, sparing them the bladder and sexual morbidity of parametrectomy, provided strict eligibility criteria are applied.
- Strict imaging and pathology criteria define low risk; misapplication to larger tumours would be unsafe.
- Longer follow-up is pending.