UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035457 |
|---|---|
| Receipt number | R000040395 |
| Scientific Title | Randomized trial for the prevention of high-output stoma after ileostomy formation |
| Date of disclosure of the study information | 2019/03/23 |
| Last modified on | 2021/11/15 11:31:40 |
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Basic information
Public title
Randomized trial for the prevention of high-output stoma after ileostomy formation
Acronym
Prevention of High-Output Stoma trial (PHOS trial)
Scientific Title
Randomized trial for the prevention of high-output stoma after ileostomy formation
Scientific Title:Acronym
Prevention of High-Output Stoma trial (PHOS trial)
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Goreisan use for accompanying symptoms (dehydration, electrolyte disturbance, etc.) owing to high-output stoma following colorectal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rehydration
Key secondary outcomes
Age, gender, comorbidity (eg, diabetes mellitus), short bowel, intra-abdominal sepsis, enteritis (eg, clostridium), recurrent disease in the remaining bowel (eg, Ulcerative colitis or Crohn's disease), sudden cessation of drugs (eg, steroids or opiates), administration of prokinetics (eg, metoclopramide), preoperative chemotherapy, preoperative radiotherapy, Body weight change (Total body water), treatment of electrolyte disturbance, daily stoma output (ml/day), evaluation of the symptoms such as nausea, headache, fatigue, anorexia, abdominal pain (VAS score), assessment of the peristomal inflammation, hospital stay, rate of readmission
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Oral administration test drug (Goreisan) 7.5g (2.5g/pack*3 packs) before meals and test drug (BIO-THREE) 3g (1g/tab*3 tabs) after meals.
Interventions/Control_2
Oral administration test drug (BIO-THREE) 3g (1g/tab*3 tabs) after meals.
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
1)Patients received surgery with ileostomy for colorectal disease
2)Patients who can orally administration
Key exclusion criteria
1)Patients with severe comorbidity
2)Patients with organ dysfunction
3)Patients requiring emergency surgery
4)Patients with Stage IV colorectal cancer
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hamamoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department General and Gastroenterological Surgery
Zip code
569-8686
Address
Takatsuki
TEL
072-683-1221
hiroki.hamamoto@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Hamamoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department General and Gastroenterological Surgery
Zip code
569-8686
Address
Takatsuki
TEL
072-683-1221
Homepage URL
hiroki.hamamoto@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University Institutional Review Board
Address
2-7, Daigakumachi
Tel
072-683-1221
rinri@osaka-med.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2019 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040395
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
