UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062237 |
|---|---|
| Receipt number | R000071218 |
| Scientific Title | A Randomized Controlled Trial of a New Oral Sulfate Solution for Bowel Preparation |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/15 16:01:26 |
* 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
A Randomized Controlled Trial of a New Oral Sulfate Solution for Bowel Preparation
Acronym
ROBO study
Scientific Title
A Randomized Controlled Trial of a New Oral Sulfate Solution for Bowel Preparation
Scientific Title:Acronym
ROBO study
Region
| Japan |
Condition
Condition
Cases who are deemed necessary for a colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the administration of a new oral sulphate solution in plastic bottles (NOSS-P) using a split-dose method for bowel preparation (BP) increases the rate of morning colonoscopy (MC: colonoscopy performed in the morning).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of cases that achieved completion of bowel preparation between 9.00 am and 12.00 pm on the day of the MC, for which the Aronchick Bowel Preparation Scale (ABPS) score was excellent or good
Key secondary outcomes
1. Time taken to complete bowel preparation on the day of the MC (time required from 9.00 am)
2. Total dose of NOSS-P plus water
3. Intestinal cleansing score (ABPS)
4. Duration of colonoscopy
5. Cecum reach rate
6. ADR
7. SDR
8. Complications (abdominal pain, nausea or vomiting, intestinal obstruction, intestinal perforation, dehydration, renal impairment, electrolyte abnormalities (hypokalaemia or hypomagnesium
), tachycardia, hypotension, aspiration, suffocation, allergic reactions (rash, malaise, hypotension), palpitations caused by antispasmodics,
nausea, impaired consciousness, agitation caused by sedatives/analgesics, hypotension, hypoxaemia, post-procedure bleeding (colonic haemorrhage), peritonitis, thromboembolism
, aspiration pneumonia)
9. Satisfaction with the bowel preparation method
10. Satisfaction with the taste of the bowel preparation medication
11. Satisfaction with the dosage of the bowel preparation medication
12. Severity of abdominal pain
13. Severity of nausea
14. Severity of sleep disturbance
15. Level of anxiety regarding toilet facilities whilst travelling to the clinic
16. Whether the patient would wish to undergo the same examination next time
17. Overall satisfaction
18. Duration of sleep on the day before the colonoscopy
19. Number of bowel movements on the day before and the day of the colonoscopy
20. Time of dinner on the day before the colonoscopy
21. Time of commencement of NOSS-P administration on the day before the colonoscopy
22. Time of completion of NOSS-P administration on the day before the colonoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bowel preparation regimen (same-day NOSS-P administration)
Interventions/Control_2
Bowel preparation regimen (split-dose NOSS-P administration)
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
Patients aged 20 or over undergoing MC at Keio University Hospital.
Key exclusion criteria
1. Cases where the patient is unable to attend the clinic by 9.00 am on the day of the MS (as MC cannot be administered)
2. Cases where the patient is unable to correctly understand the method of administration for NOSS-P (as MC cannot be administered)
3. Cases with a history of hypersensitivity to any of the components of this medicinal product
4. Cases where gastrointestinal obstruction or intestinal obstruction is suspected
5. Cases with intestinal perforation
6. Cases with gastric stasis
7. Cases of toxic megacolon
8. Patients with severe renal impairment (creatinine clearance less than 30 mL/min)
9. Any other cases deemed unsuitable for participation in this study by the principal investigator or a co-investigator
Target sample size
194
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Atshushi |
| Middle name | |
| Last name | Nakayama |
Organization
Keio University School of Medicine
Division name
Cancer center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
anakayama34@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071218
