UMIN-CTR Clinical Trial

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
Email	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
Email	nhaga@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University, Faculty of Medicine,
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051585