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The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.
The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.
The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.
Secondary endpoints include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traditional laparoscopic surgery type | Active Comparator |
| |
| Robotic assisted operation type | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional surgery type | Procedure | Traditional laparoscopic surgery for endometrial cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| the operation time | From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding | Duration of hospital stay, an expected average of 5 weeks | |
| Number of participants with adverse events | Duration of hospital stay, an expected average of 5 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | P.O.Box 2000 | 33521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28937446 | Derived | Vuorinen RK, Maenpaa MM, Nieminen K, Tomas EI, Luukkaala TH, Auvinen A, Maenpaa JU. Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer. Int J Gynecol Cancer. 2017 Oct;27(8):1788-1793. doi: 10.1097/IGC.0000000000001073. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Robotic assisted laparoscopic surgery | Procedure | Robotic assisted laparoscopic surgery for endometrial cancer |
|
| Pain |
visual analogue scale |
| Duration of hospital stay, an expected average of 5 weeks |
| pelvic lymph node volumes | Duration of hospital stay, an expected average of 5 weeks |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |