UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045154 |
|---|---|
| Receipt number | R000051585 |
| Scientific Title | trial of abbreviation of enema before urologic surgery related ERAS |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2021/08/13 21:20:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
trial of abbreviation of enema before urologic surgery related ERAS
Acronym
trial of abbreviation of enema before urologic surgery related ERAS
Scientific Title
trial of abbreviation of enema before urologic surgery related ERAS
Scientific Title:Acronym
trial of abbreviation of enema before urologic surgery related ERAS
Region
| Japan |
Condition
Condition
prostate cancer, renal cancer, bladder cancer, renal pelvic cancer, ureter cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of undergoing urologic surgeries, we would undergo those with and without enema.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fecal contamination of surgical field
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
urologic surgeries with or without enema
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
| 16 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with prostate cancer, renal cancer, bladder cancer, renal pelvic cancer, and ureter cancer
Key exclusion criteria
the patients who would not reply the questionnaire.
the patients who would regularly undergo enema
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | Haga |
| Last name | Haga |
Organization
Fukuoka University, Faculty of Medicine
Division name
Department of Urology
Zip code
814-0180
Address
45-1, 7-chome Nanakuma, Jonan-ku Fukuoka
TEL
0928011011
nhaga@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | Haga |
| Last name | Haga |
Organization
Fukuoka University, Faculty of Medicine,
Division name
Department of Urology
Zip code
814-0180
Address
45-1, 7-chome Nanakuma, Jonan-ku Fukuoka
TEL
0928011011
Homepage URL
nhaga@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University, Faculty of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University, Faculty of Medicine,
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University, Faculty of Medicine,
Address
45-1, 7-chome Nanakuma, Jonan-ku Fukuoka
Tel
0928011011
nhaga@fukuoka-u.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
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051585
