Unique ID issued by UMIN | UMIN000053845 |
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Receipt number | R000061432 |
Scientific Title | Introduction of robot-assisted Robot-assisted sacrocolpopexy for pelvic organ prolapse |
Date of disclosure of the study information | 2024/03/13 |
Last modified on | 2024/03/13 10:53:39 |
Introduction of robot-assisted Robot-assisted sacrocolpopexy for pelvic organ prolapse
Robot-assisted sacrocolpopexy
Introduction of robot-assisted Robot-assisted sacrocolpopexy for pelvic organ prolapse
Robot-assisted sacrocolpopexy
Japan |
pelvic organ prolapse
Obstetrics and Gynecology |
Others
NO
To evaluate the safety and efficacy of robot-assisted Robot-assisted sacrocolpopexy for pelvic organ prolapse
Safety,Efficacy
To evaluate the safety and efficacy of robot-assisted Robot-assisted sacrocolpopexy for pelvic organ prolapse
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Robot-assisted sacrocolpopexy
40 | years-old | <= |
80 | years-old | > |
Female
(1) Patients with pelvic organ prolapse who wish to undergo surgical treatment using mesh fixation.
(2) Patients who have received a full explanation of this treatment (surgery) and whose consent has been obtained (including consent for annual reporting to the Japanese Society of Obstetrics and Gynecology, which is mandatory for facilities that perform this treatment).
(3) Patients with ECOG Performance Status 0-1
(4) Patients who can undergo general anesthesia
(5) Patients who can undergo laparoscopic surgery
(1) Patients under 40 years of age and over 80 years of age
2) Patients with a possibility of uterine malignancy in the preoperative examination
(3) Patients whose judgment ability seems to be inadequate
(4) Patients for whom mesh fixation is considered difficult by internal examination and diagnostic imaging
(5) Patients who are expected to have severe adhesions
(6) Patients with severe obesity
(7) Patients with a history of abdominal surgery that is considered difficult to perform laparoscopically
(8) Patients with abdominal aortic aneurysm
(9) Patients with cerebrovascular disorder (subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, etc.)
(10) Patients with severe glaucoma
(11) Patients with poorly controlled diabetes mellitus
(12) Women who are pregnant or may become pregnant
(13) Other patients with serious complications that the surgeon determines to be difficult to treat in this study (this procedure).
3
1st name | Yoko |
Middle name | |
Last name | Nagayoshi |
International University of Health and Welfare, Mita Hospital
Gynecologic Oncology Center / Gynecology
108-8329
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
0334518121
y-nagayoshi@iuhw.ac.jp
1st name | Yoko |
Middle name | |
Last name | Nagayoshi |
International University of Health and Welfare, Mita Hospital
Gynecologic Oncology Center / Gynecology
108-8329
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
0334518121
y-nagayoshi@iuhw.ac.jp
International University of Health and Welfare
no cost
Self funding
International University of Health and Welfare, Mita Hospital
1-4-3 Mita, Minato-ku Tokyo, 108-8329 JAPAN
0334518121
y-nagayoshi@iuhw.ac.jp
NO
2024 | Year | 03 | Month | 13 | Day |
Unpublished
Open public recruiting
2024 | Year | 03 | Month | 07 | Day |
2024 | Year | 03 | Month | 07 | Day |
2024 | Year | 03 | Month | 07 | Day |
2026 | Year | 02 | Month | 28 | Day |
2024 | Year | 03 | Month | 13 | Day |
2024 | Year | 03 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061432
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