UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037260 |
|---|---|
| Receipt number | R000042447 |
| Scientific Title | Predictors of inadequate bowel preparation for colonoscopy in patients receiving 1 liter of polyethylene glycol plus ascorbic acid: development and validation of a predictive score |
| Date of disclosure of the study information | 2019/07/03 |
| Last modified on | 2023/10/04 21:52:29 |
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Basic information
Public title
Predictors of inadequate bowel preparation for colonoscopy in patients receiving 1 liter of polyethylene glycol plus ascorbic acid: development and validation of a predictive score
Acronym
Predictors of inadequate bowel preparation for colonoscopy in patients receiving 1 liter of polyethylene glycol plus ascorbic acid: development and validation of a predictive score
Scientific Title
Predictors of inadequate bowel preparation for colonoscopy in patients receiving 1 liter of polyethylene glycol plus ascorbic acid: development and validation of a predictive score
Scientific Title:Acronym
Predictors of inadequate bowel preparation for colonoscopy in patients receiving 1 liter of polyethylene glycol plus ascorbic acid: development and validation of a predictive score
Region
| Japan |
Condition
Condition
outpatients who underwent scheduled colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to design and validate a predictive model for inadequate bowel preparation.
Basic objectives2
Others
Basic objectives -Others
Adequate bowel preparation is essential for optimal colonoscopy. It is important to identify patients at risk for inadequate bowel preparation because this allows to perform intensified bowel cleaning regimen in this specific group.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Inadequate bowel preparation defined as Boston bowel preparation scale score <6
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatients who underwent colonoscopy
Key exclusion criteria
1)failed complete intake of bowel preparation agent
2)mechanical bowel obstruction
3)failed cecal intubation
4)current pregnancy/lactating
5)active inflammatory bowel disease
6)contraindication to bowel preparation (congestive heart failure, renal insufficiency, liver failure, a life-threatening condition)
7)refusal to provide consent
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fukuda |
Organization
Minami Osaka Hospital
Division name
Gastroenterology
Zip code
559-0012
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka, Japan
TEL
+81666850221
t.fukuda@minamiosaka.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Higashimori |
Organization
Minami Osaka Hospital
Division name
Gastroenterology
Zip code
559-0012
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka, Japan
TEL
+81666850221
Homepage URL
higamo@med.osaka-cu.ac.jp
Sponsor or person
Institute
Minami Osaka Hospital
Institute
Department
Personal name
Funding Source
Organization
Minami Osaka Hospital
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
Minami Osaka Hospital
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka, Japan
Tel
+81666850221
higamo@med.osaka-cu.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
南大阪病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
doi: 10.1007/s10620-023-08089-8.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1007/s10620-023-08089-8.
Number of participants that the trial has enrolled
1157
Results
Overall, 1054 patients were enrolled, of which, 105 (10%) had inadequate bowel preparation. The risk of inadequate BP increased with constipation severity (P=0.01). Multivariate analysis showed that frequent straining and chronic use of stimulant laxatives were significant predictors of inadequate BP, among personal bowel habits.
Results date posted
| 2023 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligible subjects were outpatients aged less than 20 years scheduled for elective afternoon colonoscopy. Exclusion criteria were: (i) severe heart failure (New York Heart Association class III or IV), (ii) severe liver failure (Child-Pugh classification grade C), (iii) active inflammatory bowel disease, (iv) dementia with difficulty following instructions, (v) allergy to PEG-Asc or senna, (vi) suspected bowel obstruction, and (vii) prior colectomy. After screening the patients according to these criteria, written informed consent was obtained.
Participant flow
All patients were given verbal and written instructions by the coordinator how to take the BP solution. Patients were instructed to consume a low-fiber diet and stop laxatives other than agents in the regimen on the day before the examination. Patients were scheduled for colonoscopy within 2 weeks of these instructions to improve their compliance. On the day before the colonoscopy, 24 mg of senna was taken before bedtime, as previously described.16 On the same day of the colonoscopy, 2L of polyethylene glycol plus ascorbic acid solution was administered 4-6 h before the procedure at a rate of 500 mL every 30 min. Patients were instructed to complete the procedure at least 2 h before their colonoscopies. Patients were instructed to take clear fluids after BP to ensure adequate hydration.
Adverse events
None
Outcome measures
Factors associated with inadequate bowel preparation were determined using logistic regression analysis and odds ratios and their 95% confidence intervals were calculated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
a prospective qestionnaire-based observational study
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042447
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