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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028033 |
Receipt No. | R000032099 |
Scientific Title | Incidence and risk factor of outlet obstruction after construction of ileostomy |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/07/01 |
Basic information | ||
Public title | Incidence and risk factor of outlet obstruction after construction of ileostomy | |
Acronym | Risk factor of outlet obstruction | |
Scientific Title | Incidence and risk factor of outlet obstruction after construction of ileostomy | |
Scientific Title:Acronym | Risk factor of outlet obstruction | |
Region |
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Condition | ||
Condition | Ulcerative colitis, Familiar adenomatous polyposis, rectal cancer, etc | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the frequency and risk factors of outlet obstruction after construction of ileostomy. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Risk factors of outlet obstruction after construction of ileostomy. |
Key secondary outcomes | Incidence of outlet obstruction after construction of ileostomy. |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Patients those who were constructed ileostomy at Chiba university Hospital between January 2010 to December 2015.
2) Presence of detailed surgical record |
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Key exclusion criteria | 1) Patients who died within 30 days after surgery
2) Patients who died without being able to ingest orally even at once after surgery |
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Target sample size | 107 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate school of medicine, Chiba University
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Division name | Department of frontier surgery | ||||||
Zip code | |||||||
Address | 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken | ||||||
TEL | 043-226-2110 | ||||||
matsuhm@faculty.chiba-u.jp |
Public contact | |||||||
Name of contact person |
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Organization | Graduate school of medicine, Chiba University | ||||||
Division name | Department of frontier surgery | ||||||
Zip code | |||||||
Address | 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken | ||||||
TEL | 043-226-2110 | ||||||
Homepage URL | |||||||
Ohira@faculty.chiba-u.jp |
Sponsor | |
Institute | Graduate school of medicine, Chiba University |
Institute | |
Department |
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 | |
Address | |
Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | We accumulated data of 107 cases as planned. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032099 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |