Laparoscopic Approach to Cancer of the Endometrium
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|ClinicalTrials.gov Identifier: NCT00096408|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Procedure: Total Abdominal Hysterectomy Procedure: Total Laparoscopic Hysterectomy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||760 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial|
|Actual Study Start Date :||October 2005|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||December 2018|
Active Comparator: 1
Total Abdominal Hysterectomy
Procedure: Total Abdominal Hysterectomy
For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.
Total Laparoscopic Hysterectomy
Procedure: Total Laparoscopic Hysterectomy
The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.
Other Name: Keyhole hysterectomy
- Disease free survival [ Time Frame: 4.5 years from surgery ]
- Intra/Peri/Post-operative and long-term morbidity [ Time Frame: 30 days from surgery ]
- Patterns of recurrence [ Time Frame: 4.5 years from surgery ]
- Pain and analgesia [ Time Frame: 1 week, 1 month, 3 months and 6 months postoperative. ]
- Quality of Life [ Time Frame: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096408
|Principal Investigator:||Andreas Obermair||Queensland Centre for Gynaecological Cancer|