Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096408
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2004-11-09
Brief Title:
Laparoscopic Approach to Cancer of the Endometrium
Sponsor:
Queensland Centre for Gynaecological Cancer
Organization:
Queensland Centre for Gynaecological Cancer
Study Overview
Official Title:
LACE - Laparoscopic Approach to Cancer of the Endometrium An International Multicenter Randomized Phase 3 Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess disease-free survival at 45 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None