UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041628 |
|---|---|
| Receipt number | R000047520 |
| Scientific Title | A histological cohort study fo assess the adverse events using Adspray in laparoscopic surgery for early uterine endometrial cancer. |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2023/03/22 13:46:17 |
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Basic information
Public title
A histological cohort study fo assess the adverse events using Adspray in laparoscopic surgery for early uterine endometrial cancer.
Acronym
Adieu study
Scientific Title
A histological cohort study fo assess the adverse events using Adspray in laparoscopic surgery for early uterine endometrial cancer.
Scientific Title:Acronym
Adieu study
Region
| Japan |
Condition
Condition
Uterine endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of using Adspray in Laparoscopic surgery including pelvic lymph node dissection (not including para-aortic lymph node dissection) for early endometrial cancer with presumed advanced stage classification (FIGO2008) stage IA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative infection within 30 days after surgery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with presumed advanced stage classification (FIGO2008) stage IA endometrial cancer who scheduled for laparoscopic hysterectomy including pelvic lymph node dissection (not including para-aortic lymph node dissection. robot-assisted surgery using da Vinci surgical system is acceptable).
2. Patients planning to use Adspray
3. ECOG performance Status 0 or 1.
4. Informed written consent is obtained.
Key exclusion criteria
1. Patients scheduled for laparotomy.
2. Patients scheduled for surgery without pelvic lymph node dissection.
3. Patients scheduled for para-aortic lymph node dissection.
4. Patients with pelvic infection or infectious diseases requiring treatment.
5. History of obstructive bowel disease.
6. History of pelvic radiation therapy.
7. Patients who are judged to be inappropriate as subject to this study by the physician.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Tabata |
Organization
Tokyo Women's Medical University
Division name
Gynecology
Zip code
162-8666
Address
8-1,Kawadacho,Shinjuku-ku,Tokyo
TEL
03-3353-8111
tabata.tsutomu@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Motohashi |
Organization
Tokyo Women's Medical University
Division name
Gynecology
Zip code
162-8666
Address
8-1,Kawadacho,Shinjuku-ku,Tokyo
TEL
03-3353-8111
Homepage URL
sr21det@rb3.so-net.ne.jp
Sponsor or person
Institute
Tokyo women's medical university
Institute
Department
Personal name
Funding Source
Organization
TERUMO CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1,Kawadacho,Shinjuku-ku,Tokyo
Tel
0333538111
tabata.tsutomu@twmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the main purpose is to grasp the adverse events by using Adspray when performing the laparoscopic hysterectomy with pelvic lymph node dissection (without para-aortic lymph node dissection) for endometrial cancer presumed advanced stage classification (FIGO2008) stage IA.
As a comparative control, at the participating facilities of this study, we investigate the information when similar surgery was performed on cases with the same condition as historical control(retrospective observational study), and compare with the results of the prospective observational study.
Management information
Registered date
| 2020 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047520
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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