Endometrial Cancer Clinical Trial
Official title:
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).
This phase III international, multicenter, open-label, randomized clinical trial is an
equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is
associated with equivalent disease-free survival when compared to the standard treatment of
Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.
The secondary hypotheses are:
- TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;
- TLH is associated with reduced treatment-related morbidity;
- TLH is associated with shorter hospital stay;
- TLH is associated with less analgesic consumption;
- TLH is cost effective;
- TLH is associated with improved pelvic floor function.
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