The uterus, tubes, ovaries, and lymph nodes are all removed as part of standard endometrial cancer treatment. Only a few randomized trials examined surgical procedures in terms of disease-free survival. In women with treatment-naive endometrial cancer, researchers wanted to know if total laparoscopic hysterectomy (TLH) was equal to total abdominal hysterectomy (TAH).
The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was a multinational, randomized equivalence trial conducted between October 7, 2005, and June 30, 2010, in which 760 women with stage I endometrioid endometrial cancer were randomized to either TLH or TAH by 27 surgeons from 20 tertiary gynecological cancer centers in Australia, New Zealand, and Hong Kong. On March 3, 2016, the follow-up period came to a conclusion. The primary outcome was disease-free survival, which was defined as the time between surgery and the date of the first recurrence, which included disease progression, the formation of new primary malignancy, or death at 4.5 years following randomization.
A median of 4.5 years was spent following up on the patients. The experiment was completed by 679 (89%) of the 760 participants who were randomized (mean age, 63 years). Disease-free survival was 81.3% in the TAH group and 81.6% in the TLH group after 4.5 years. The difference in disease-free survival rate was 0.3% (favoring TLH; 95% CI, 5.5% to 6.1%; P =.007), fulfilling equivalence requirements. There was no statistically significant between-group difference in endometrial cancer recurrence (28/353 in TAH group [7.9%] vs 33/407 in TLH group [8.1%]; risk difference, 0.2% [95% CI, 3.7% to 4.0%]; P =.93) or overall survival (24/353 in TAH group [6.8%] vs 30/407 in TLH group [7.4%]; risk difference, 0.6% [95% CI, −3.0% to 4.2%]; P = .76).