UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036382 |
|---|---|
| Receipt number | R000041026 |
| Scientific Title | A study evaluating the safety of early closure of diverting ileostomy after low anterior resection |
| Date of disclosure of the study information | 2019/04/03 |
| Last modified on | 2022/05/10 12:50:04 |
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Basic information
Public title
A study evaluating the safety of early closure of diverting ileostomy after low anterior resection
Acronym
Eraly closure of eleostomy after LAR
Scientific Title
A study evaluating the safety of early closure of diverting ileostomy after low anterior resection
Scientific Title:Acronym
Eraly closure of eleostomy after LAR
Region
| Japan |
Condition
Condition
Rectum
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the safety of early closure of diverting ileostomy after low anterior resection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of anastomotic leakage after early closure
Key secondary outcomes
tha rate of early closure
rate of surgical site infection
rate of complications
detection of leakage before stoma closure
medical cost
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
early closure of diverting ileostomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ra or Rb rectal cancer proved by endoscopy or pathological examination.
Low anterior resection and creation of covering ileostomy is planned.
Rectal cancer without metastasis is diagnosed.
Patients are age at 20 or more than 20.
Informed consents are obtained.
No severe dysfunction in vital organs is pointed out.
Key exclusion criteria
When the investigator considers recruitment of the patients is inappropriate (ie. severe organ dysfunction).
When informed consent is not obtained.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hanazaki |
| Middle name | |
| Last name | Kazuhiro |
Organization
Kochi Medical Shool
Division name
Surgery
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi
TEL
088-880-2370
hanazaki@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Maeda |
| Middle name | |
| Last name | Hiromichi |
Organization
Kochi Medical Shool Hospital
Division name
Surgery
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi
TEL
088-880-2370
Homepage URL
hmaeda@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
none
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
Kochi Medical School
Address
Oko-cho, Kohasu, Nankoku, Kochi
Tel
088-880-2226
rinri21@kochi-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
| 2019 | Year | 04 | Month | 03 | 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
13
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
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041026
