UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023074 |
|---|---|
| Receipt number | R000025422 |
| Scientific Title | LARGE BOWEL OBSTRUCTION OR PERFORATION CAUSED BY ORAL PREPARATION FOR COLONOSCOPY (Retrospective study) |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2016/07/08 11:31:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
LARGE BOWEL OBSTRUCTION OR PERFORATION CAUSED BY ORAL PREPARATION FOR COLONOSCOPY (Retrospective study)
Acronym
LARGE BOWEL OBSTRUCTION OR PERFORATION CAUSED BY ORAL PREPARATION FOR COLONOSCOPY
Scientific Title
LARGE BOWEL OBSTRUCTION OR PERFORATION CAUSED BY ORAL PREPARATION FOR COLONOSCOPY (Retrospective study)
Scientific Title:Acronym
LARGE BOWEL OBSTRUCTION OR PERFORATION CAUSED BY ORAL PREPARATION FOR COLONOSCOPY
Region
| Japan |
Condition
Condition
LARGE BOWEL OBSTRUCTION OR PERFORATION
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients undergoing bowel preparation for colonoscopy are at risk of potentially severe adverse events such as large-bowel obstruction (LBO) and perforation. These patients usually need emergency surgery and the events are sometimes fatal; however, details of these adverse events are unknown. The present study is an initial systematic report that analyzes LBO and perforation caused by oral preparation for colonoscopy.
Basic objectives2
Others
Basic objectives -Others
adverse events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated 10 clinical factors for each patient: age, sex, symptoms at the first visit, preparation drug, location of LBO/perforation, pathogenesis, rate of surgery, rate of emergency surgery, rate of colostomy and mortality. From these data, we analyzed the pathogenesis of LBO and perforation, and we propose prophylactic measures for these adverse events.
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
The subjects of the study were patients at Showa University Northern Yokohama Hospital between April 2001 and December 2015, who were diagnosed with LBO or perforation caused by oral preparations.
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Yamauchi |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-Chuo Tsuzuki-ku, Yokohama-shi, Kanagawa 224-8503 Japan
TEL
09024540053
showyou0913@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Yamauchi |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-Chuo Tsuzuki-ku, Yokohama-shi, Kanagawa 224-8503 Japan
TEL
045-949-7000
Homepage URL
showyou0913@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital, Digestive Disease Center
Institute
Department
Personal name
Funding Source
Organization
non
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
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
| 2016 | Year | 07 | Month | 08 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2016 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
