UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035457
Receipt No. 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 2019/07/08

* 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 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 Masashi
Middle name
Last name Yamamoto
Organization Osaka Medical Collage
Division name Department General and Gastroenterological Surgery
Zip code 569-8686
Address Takatsuki
TEL 072-683-1221
Email sur138@osaka-med.ac.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Yamamoto
Organization Osaka Medical Collage
Division name Department General and Gastroenterological Surgery
Zip code 569-8686
Address Takatsuki
TEL 072-683-1221
Homepage URL
Email sur138@osaka-med.ac.jp

Sponsor
Institute Osaka Medical Collage
Institute
Department

Funding Source
Organization Osaka Medical Collage
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 Collage Institutional Review Board
Address 2-7, Daigakumachi
Tel 072-683-1221
Email 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
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040395

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.