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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010530
Receipt No. R000012313
Scientific Title Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Date of disclosure of the study information 2013/05/01
Last modified on 2019/05/31

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Basic information
Public title Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Acronym Ileal flap study
Scientific Title Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate
Scientific Title:Acronym Ileal flap study
Region
Japan

Condition
Condition Lower rectal cancer involving the prostate
Classification by specialty
Gastrointestinal surgery Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Improvement and prevention of cysto-urethral anastomotic leakage.
Safety of additional flap operation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cysto-urethral anastomotic leak rate at postoperative one month.
Key secondary outcomes Rate of major leakage in cysto-urethral anastomosis.
Healing term of CUA leakage.
Safety of flap operation.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Additional ileal flap operation in cysto-urethral anastomosis.
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
75 years-old >=
Gender Male
Key inclusion criteria 1.Male patients with locally advanced rectal cancer involving the prostate clinically.
2.Pathological proven adenocarcinoma.
3.Possible to be preservation of the sphincter urethrae.
4.With or Without anus-preservation.
5.No distant metastasis.
6.Normal length of the small intestine.
7.Aged 20 to 75 years old.
8.PS(ECOG) of 0 or 1.
9.Enough organ functions.
WBC count : >=3000/mm3
Platelet count : >=70000/mm3
Hemoglobin : >=8.0g/dl
T-Bil : <=1.5mg/dl
AST : <=100IU/l
ALT : <=100IU/l
Cr : <=1.5mg/dl
Alb : >=2.8g/dl
10. With or Without previous radiotherapy and chemotherapy.
11. Writhen informed consent.
Key exclusion criteria 1. Patients with request of total pelvic exenteration (TPE), or patients without request of the ileal flap operation.
2. Impossible to be curative resection.
3. Patients with serious disease as follows.
Uncontrollable diabetes mellitus(Hba1c >=8%)
renal failure requiring artificial dialysis.
requiring immunosuppressants
4. Patients with serious organ failure.
5. Cannot agree on this study.
6. Unsuitable patients for this study.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Saito
Organization National Cancer Center Hospital East
Division name Colorectal and Pelvic Surgery
Zip code
Address 6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
TEL 04-7133-1111
Email norsaito@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Saito
Organization National Cancer Center Hospital East
Division name Colorectal and Pelvic Surgery
Zip code
Address 6-5-1, Kashwanoha, Kashiwa, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email norsaito@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立がん研究センター東病院(千葉県)
愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 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 Completed
Date of protocol fixation
2013 Year 03 Month 13 Day
Date of IRB
2013 Year 03 Month 04 Day
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 09 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 18 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012313

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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