Unique ID issued by UMIN | UMIN000013229 |
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Receipt number | R000015439 |
Scientific Title | An investigation of the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer |
Date of disclosure of the study information | 2014/03/01 |
Last modified on | 2021/03/16 12:57:28 |
An investigation of the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Robot-assisted laparoscopic surgery for cervical and uterine cancer
An investigation of the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Robot-assisted laparoscopic surgery for cervical and uterine cancer
Japan |
cervical cancer and uterine cancer
Obstetrics and Gynecology |
Malignancy
NO
To validate the safety and efficacy of robot-assisted laparoscopic surgery for cervical and uterine cancer
Safety,Efficacy
Exploratory
Pragmatic
Operation time, console time, blood loss, intra-operative/post-operative complications will be recorded, which will be compared to those of open surgery for cervical and uterine cancers.
Histopathological completeness of surgery, number of lymph nodes harvested, post-operative bladder function, 5-year recurrence free survival and the site of recurrence.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Patients with cervical cancer or uterine cancer, who are eligible for radical surgery and provide voluntary consent by signing the written informed consent documents, will undergo robot-assisted radical surgery. Their peri-operative courses will be closely observed and the primary and secondary outcome measures will be investigated. Post-operative bladder function will be examined at 3, 6, and 12 months after surgery. Recurrence will be checked for 5 years after surgery.
20 | years-old | <= |
Not applicable |
Female
1. Women who are 20 years old at the time of giving informed consent.
2. Patient with clinical stage I – II cervical cancer or patients who are supposed to have surgical stage I – III uterine cancer (cervical cancer is staged before treatment and uterine cancer is staged after surgery by histo-pathological examination).
3.PS: 0 – 1
4. Patients who have been given information and who have discussed the risks, benefits and other aspects of the trial with principal investigator and who provide voluntary consent by signing the written informed consent documents.
1. Patient with cervical or uterine cancer with specific subtype of undifferentiated carcinoma, small cell carcinoma, clear cell adenocarcinoma, glassy cell carcinoma.
2. Patients who are judged to be not eligible for the study.
10
1st name | |
Middle name | |
Last name | Noriaki Sakuragi |
Hokkaido University Graduate School of Medicine
Department of Gynecology
Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
011-706-5938
sakuragi@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Noriaki Sakuragi |
Hokkaido University Graduate School of Medicine
Department of Gynecology
Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
011-706-5938
sakuragi@med.hokudai.ac.jp
Department of Gynecology, Hokkaido University Graduate School of Medicine
Hokkaido University Hospital and the Department of Gynecology, Hokkaido University Graduate School of Medicine
NO
2014 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 02 | Month | 28 | Day |
2014 | Year | 03 | Month | 01 | Day |
2023 | Year | 10 | Month | 16 | Day |
2014 | Year | 02 | Month | 23 | Day |
2021 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015439
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