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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023074
Receipt No. 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

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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
Email 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
Email showyou0913@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital, Digestive Disease Center
Institute
Department

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
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

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
URL(English) https://upload.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


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