Long-term follow-up of the Laparoscopic Approach to Carcinoma of the Endometrium (LACE) Trial - survival outcomes (2016-2018)

Several years ago we initiated the LACE trial comparing Total Abdominal Hysterectomy (TAH) with Total Laparoscopic Hysterectomy (TLH) among a total of 760 patients with Endometrial Cancer (EC). LACE was funded by NHMRC 2007-09 [456110], Cancer Australia 2010-12 [631523] and has fulfilled its initial objectives. We showed that TLH significantly improved postoperative recovery (better short-term quality of life (QOL); reduced complication rates); and is cost effective when compared to TAH. LACE results were recognised nationally and internationally. Already, in that initial proposal, we indicated that further funds would be sought to assess the project¿¿¿s primary outcome of disease-free survival at 4 ¿¿ years. It is thus critically important that support for this follow up is made available from the current funding round. This will secure optimal return on NHMRC¿¿¿s original investment, ensure timely evaluation of the primary hypothesis of the overall trial: that survival of patients receiving TLH is equivalent to those patients receiving TAH. In addition, existing LACE data resources allow to answer three additional, novel research questions. Primary Aim 1. Investigate if women randomised to TLH will have at least equivalent overall and disease free survival 4 ¿¿ years after surgery compared to patients randomised to TAH. We will also: Aim 2. Describe the pelvic floor wellbeing in women before surgery compared to 4 ¿¿ years after surgery, and examine if there is a clinically important difference between treatment arms. Aim 3. Describe the long-term QoL and lifestyle status (including BMI, physical activity, diet) of EC patients 5 to 10 years after surgery, and examine if there are differences between randomised treatment arms. Aim 4. Explore the patients¿¿¿ views on the motivators and barriers to lifestyle changes or persistent lifestyle detriments in EC patients and how they believe these can be impro...