Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial

Janda, M., Gebski, V., Forder, P., Jackson, D., Williams, G. and Obermair, A. (2006) Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial. Contemporary Clinical Trials, 27 4: 353-363. doi:10.1016/j.cct.2006.03.004

Author Janda, M.
Gebski, V.
Forder, P.
Jackson, D.
Williams, G.
Obermair, A.
Title Total laparoscopic versus open surgery for stage 1 endometrial cancer: The LACE randomized controlled trial
Journal name Contemporary Clinical Trials   Check publisher's open access policy
ISSN 1551-7144
Publication date 2006
Sub-type Article (original research)
DOI 10.1016/j.cct.2006.03.004
Volume 27
Issue 4
Start page 353
End page 363
Total pages 11
Place of publication New York , U.S.A.
Publisher Elsevier Science Inc
Collection year 2006
Language eng
Subject C1
321014 Obstetrics and Gynaecology
730201 Women's health
Formatted abstract

Endometrial cancer is the most common gynaecological malignancy in Australia and the US. Current standard treatment involves open surgery to remove the uterus, and both tubes and ovaries (TAH). The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was designed to assess equivalence of performing this in a total laparoscopic approach (TLH).


Patient recruitment was designed to proceed along two stages to accommodate for a potential increase in patient requests of laparoscopic surgery. During the first stage, patients are randomised in a 2:1 allocation to receive TLH or TAH, with the primary endpoint quality of life (QoL) at 6 month post-surgery, requiring 180 patients to be enrolled to have 80% power at α = 0.05 to detect a clinically significant difference of 8 points on the Functional Assessment of Cancer General (FACT-G) QoL instrument. If additional recruitment of patients seems impossible after accrual of 180 patients, this cohort will be followed for 4 years, and disease free survival (DFS) of patients treated by TLH will be compared to DFS within the endometrial cancer population. During the second stage, recruitment will be extended to a total of 590 patients in a 1:1 TLH:TAH allocation, to assess the equivalence with respect to DFS with 80% power and α = 0.05. Equivalence will be assumed if the difference in DFS does not exceed 7% at 4 years. Secondary outcomes include treatment related morbidity; costs and cost-effectiveness; patterns of recurrence; and overall survival. All data from this multicentre study will be entered using online electronic case report forms (e-CRF), allowing real time assessment of data completeness and patient follow-up.


The LACE trial will establish the equivalence of a TLH approach for patients with stage 1 endometrial cancer following a two stage protocol to accommodate potential threats to patient recruitment through requests for laparoscopic surgery.
Keyword edometrial cancer
laparoscopic surgery
phase III clinical trial
quality of life
body image
health care cost
Assisted Vaginal Hysterectomy
Abdominal Hysterectomy
Missing Data
Q-Index Code C1

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Created: Wed, 15 Aug 2007, 09:24:59 EST