UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039856 |
|---|---|
| Receipt number | R000045432 |
| Scientific Title | Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2020/03/18 00:25:16 |
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Basic information
Public title
Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Acronym
Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Scientific Title
Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Scientific Title:Acronym
Risk factors for postoperative small bowel obstruction after surgery for colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating risk factors for small bowel obstruction after colorectal cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of small bowel obstruction
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal cancer who undergo operation in Second Department of Surgery, Wakayama Medical University or our related hospitals
Key exclusion criteria
(1) Patients with unresectable peritoneal dissemination nodules.
(2) Patients with a history of intraperitoneal irradiation.
(3) Patients with chronic inflammatory bowel disease (Crohn's disease / ulcerative colitis / Gastrointestinal Behcet's disease).
(4) Other cases judged by the attending physician to be maladaptive.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Hotta |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
hotta@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Matsuda |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
kmatsuda@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
和歌山県立医科大学（和歌山）、済生会和歌山病院（和歌山）、南和歌山医療センター（和歌山）、済生会有田病院（和歌山）、和歌山労災病院（和歌山）、大阪南医療センター（大阪）、公立那賀病院（和歌山）、泉大津市立病院（大阪）、国保日高総合病院（和歌山）、橋本市民病院（和歌山）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 19 | 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
985
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparation for publication of results
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
| 2009 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2009 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 29 | Day |
Other
Other related information
prospective cohort study
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045432
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