UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056459 |
|---|---|
| Receipt number | R000064513 |
| Scientific Title | Prepackaged Low-Residue Diet "Clear Through" Reduces The Required Volume Of Polyethylene Glycol Electrolyte Lavage Solution During Colonoscopy Preparation: A Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2025/12/01 20:58:02 |
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Basic information
Public title
Prepackaged Low-Residue Diet "Clear Through" Reduces The Required Volume Of Polyethylene Glycol Electrolyte Lavage Solution During Colonoscopy Preparation: A Prospective Randomized Controlled Trial
Acronym
Prepackaged Low-Residue Diet "Clear Through" Reduces The Required Volume Of Polyethylene Glycol Electrolyte Lavage Solution During Colonoscopy Preparation: A Prospective Randomized Controlled Trial
Scientific Title
Prepackaged Low-Residue Diet "Clear Through" Reduces The Required Volume Of Polyethylene Glycol Electrolyte Lavage Solution During Colonoscopy Preparation: A Prospective Randomized Controlled Trial
Scientific Title:Acronym
Prepackaged Low-Residue Diet "Clear Through" Reduces The Required Volume Of Polyethylene Glycol Electrolyte Lavage Solution During Colonoscopy Preparation: A Prospective Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Patients undergoing colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the increasing prevalence of colorectal cancer and inflammatory bowel disease, the necessity of colonoscopy has become increasingly evident. Colonoscopy requires bowel preparation, which typically includes ingesting polyethylene glycol electrolyte lavage solution (PEG-ELS). However, the large volume of PEG-ELS is often a challenge and reducing this burden could reduce the overall discomfort of colonoscopy. This study assessed whether a prepackaged low-residue diet (PLRD; Clear Through) could reduce the required volume of PEG-ELS (Moviprep).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The quality of bowel preparation, assessed by the Ottawa Bowel Preparation Scale (OBPS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
Group A consumed a self-adjusted diet and 20 mL of sodium picosulfate on the day before the procedure, followed by 1.5 L of PEG-ELS on the day of the procedure.
Interventions/Control_2
Group B consumed PLRD and 20 mL of sodium picosulfate on the day before the procedure, followed by 1.5 L of PEG-ELS on the day of the procedure.
Interventions/Control_3
Group C consumed PLRD and 20 mL of sodium picosulfate on the day before the procedure, followed by 1.0 L of PEG-ELS on the day of the procedure.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We enrolled 180 patients aged 20 - 80 years who underwent total colonoscopy at our hospital.
Key exclusion criteria
Gastrointestinal obstruction or suspected obstruction.
Intestinal perforation or suspected perforation.
Toxic megacolon or suspected toxic megacolon.
Gastric emptying disorders (gastroparesis) or suspected disorders.
Intestinal stenosis or severe constipation.
Impaired gag reflex or at risk of aspiration.
A history of gastrointestinal surgery.
Diagnosed with glucose-6-phosphate dehydrogenase deficiency.
Renal impairment (creatinine clearance <30 mL/min).
Undergoing treatment for severe cardiac disease or requiring such treatment.
High risk of arrhythmia.
Dehydration.
Diagnosed with active inflammatory bowel disease during the screening period.
Under 18 years old or over 80 years old.
A history of hypersensitivity to any component of Moviprep oral solution.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Iida |
Organization
NTT medical center Tokyo
Division name
Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-Ku, Tokyo
TEL
+81-3-3448-6111
toshifumi.iida1993@gmail.com
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Iida |
Organization
NTT medical center Tokyo
Division name
Gastrointestinal Endoscopy
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-Ku, Tokyo
TEL
+81-3-3448-6111
Homepage URL
toshifumi.iida1993@gmail.com
Sponsor or person
Institute
NTT medical center Tokyo
Institute
Department
Personal name
Funding Source
Organization
None.
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
NTT medical center Tokyo
Address
5-9-22 Higashi-Gotanda, Shinagawa-Ku, Tokyo
Tel
+81-3-3448-6111
toshifumi.iida1993@gmail.com
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
| 2024 | Year | 12 | Month | 13 | 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
180
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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064513
