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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000023895 |
Receipt No. | R000027412 |
Scientific Title | A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2019/03/21 |
Basic information | ||
Public title | A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy | |
Acronym | Split-dose vs morning-only dose preparation for afternoon colonoscopy | |
Scientific Title | A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy | |
Scientific Title:Acronym | Split-dose vs morning-only dose preparation for afternoon colonoscopy | |
Region |
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Condition | ||
Condition | Inpatient who have a plan to be performed colonoscopy | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study was to compare the efficacy of the standard regimen compared to the alternate one; repeat to take 500 ml of PEG-ASC after 250 clear liquid three times. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The primary endpoint was successful bowel cleansing. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Single blind -investigator(s) and assessor(s) are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | The standard regimen of PEG-ASC for afternoon colonoscopy in Japan is to take the first liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid, and to take 500 ml of PEG-ASC after 250 ml of clear water from 9 AM. | |
Interventions/Control_2 | The split dose regimen;
The day before colonoscopy; To take the one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 4 PM. The day of colonoscopy; To take one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 9:45 AM. |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | All patients provided written, informed consent. All consecutive inpatients of both sexes aged 20 years and older who were scheduled for mainly therapeutic colonoscopy such as polypectomy, endoscopic mucosal resection, and endoscopic submucosal dissection at ACCH. | |||
Key exclusion criteria | Patients with the following clinical features were excluded: significant cardiac, renal, hepatic, or metabolic co-morbidities, ascites, severe constipation (<2 bowel movements per week), known allergy to PEG-ELS, history of gastric stapling or bypass procedure, or history of prior colonic or rectal surgery. Patients were excluded if there was a suspected diagnosis of intestinal obstruction because of advanced colorectal cancer. | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Aichi Cancer Center Hospital | ||||||
Division name | Endoscopy | ||||||
Zip code | 464-8681 | ||||||
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan | ||||||
TEL | 052-762-6111 | ||||||
mtajika@aichi-cc.jp |
Public contact | |||||||
Name of contact person |
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Organization | Aichi Cancer Center Hospital | ||||||
Division name | Endoscopy | ||||||
Zip code | 464-8681 | ||||||
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan | ||||||
TEL | 052-762-6111 | ||||||
Homepage URL | |||||||
mtajika@aichi-cc.jp |
Sponsor | |
Institute | Aichi Cancer Center Hospital |
Institute | |
Department |
Funding Source | |
Organization | EA Pharma Co., Ltd., Tokyo, Japan |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Aichi Cancer Center Hospital |
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya, Japan |
Tel | 052-762-6111 |
irb@aichi-cc.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027412 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |