Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
760 participants
INTERVENTIONAL
2005-10-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Total Abdominal Hysterectomy
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.
2
Total Laparoscopic Hysterectomy
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed primary endometrioid adenocarcinoma of the endometrium;
* Clinical stage I disease;
* ECOG Performance status of 0-1;
* Signed written informed consent;
* Females, aged 18 years or older.
Exclusion Criteria
* Other histologic type than endometrioid adenocarcinoma of the endometrium;
* Clinically advanced disease (stages II-IV);
* Uterine size larger than 10 weeks gestation;
* Estimated life expectancy of less than 6 months;
* Enlarged aortic lymph nodes;
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patient compliance and geographic proximity that does not allow adequate follow-up;
* Unfit to complete QoL measurements.
18 Years
FEMALE
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Tyco Healthcare Group
INDUSTRY
Gynetech
INDUSTRY
Queensland Government - Smart Health Research Grant
UNKNOWN
National Health and Medical Research Council, Australia
OTHER
Cancer Council Queensland
OTHER
Cancer Council New South Wales
OTHER
Cancer Council Victoria
OTHER
Cancer Council Western Australia
UNKNOWN
Cancer Australia
OTHER
Queensland Centre for Gynaecological Cancer
OTHER_GOV
Responsible Party
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Principal Investigators
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Andreas Obermair
Role: PRINCIPAL_INVESTIGATOR
Queensland Centre for Gynaecological Cancer
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Newcastle Private Hospital
New Lambton Heights, New South Wales, Australia
Royal Hospital for Women
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Adult Public Hospital
South Brisbane, Queensland, Australia
Mater Misericordiae Hospital Townsville
Townsville, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Royal Women's Hospital
Carlton, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Cabrini Health
Malvern, Victoria, Australia
King Edward Memorial Hospital for Women
Perth, Western Australia, Australia
St John of God Hospital
Subiaco, Western Australia, Australia
Queen Mary Hospital
Pok Fu Lam, , Hong Kong
Christchurch Women's Hospital
Christchurch, Canterbury, New Zealand
Oxford Clinic Women's Health
Christchurch, , New Zealand
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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Janda M, Gebski V, Forder P, Jackson D, Williams G, Obermair A; LACE Trial Committee. Total laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial. Contemp Clin Trials. 2006 Aug;27(4):353-63. doi: 10.1016/j.cct.2006.03.004. Epub 2006 May 5.
Gebski V, Obermair A, Janda M. Toward Incorporating Health-Related Quality of Life as Coprimary End Points in Clinical Trials: Time to Achieve Clinical Important Differences and QoL Profiles. J Clin Oncol. 2022 Jul 20;40(21):2378-2388. doi: 10.1200/JCO.21.02750. Epub 2022 May 16.
Janda M, Gebski V, Davies LC, Forder P, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Robertson G, Walker G, Armfield NR, Graves N, McCartney AJ, Obermair A. Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1224-1233. doi: 10.1001/jama.2017.2068.
Belavy D, Janda M, Baker J, Obermair A. Epidural analgesia is associated with an increased incidence of postoperative complications in patients requiring an abdominal hysterectomy for early stage endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):423-9. doi: 10.1016/j.ygyno.2013.08.027. Epub 2013 Sep 3.
Kondalsamy-Chennakesavan S, Janda M, Gebski V, Baker J, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede DH, Pather S, Simcock B, Farrell R, Robertson G, Walker G, McCartney A, Obermair A. Risk factors to predict the incidence of surgical adverse events following open or laparoscopic surgery for apparent early stage endometrial cancer: results from a randomised controlled trial. Eur J Cancer. 2012 Sep;48(14):2155-62. doi: 10.1016/j.ejca.2012.03.013. Epub 2012 Apr 12.
Janda M, Gebski V, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, McCartney A, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Walsh T, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Obermair A. Quality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): a randomised trial. Lancet Oncol. 2010 Aug;11(8):772-80. doi: 10.1016/S1470-2045(10)70145-5. Epub 2010 Jul 16.
Related Links
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Gynaecological Oncology website
QCGC Research
Other Identifiers
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LACE001
Identifier Type: -
Identifier Source: org_study_id
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