UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040129 |
|---|---|
| Receipt number | R000045756 |
| Scientific Title | Comparative study of the effects of Daikenchuto and lactobacillus preparation on abdominal symptoms after laparoscopic sacrocolpopex for pelvic organ prolapse: A randomized, prospective study |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2023/04/13 09:02:58 |
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Basic information
Public title
Comparative study of the effects of Daikenchuto and lactobacillus preparation on abdominal symptoms after laparoscopic sacrocolpopex for pelvic organ prolapse: A randomized, prospective study
Acronym
Comparative study of Daikenchuto and lactobacillus preparation after laparoscopic sacrocolpopexy
Scientific Title
Comparative study of the effects of Daikenchuto and lactobacillus preparation on abdominal symptoms after laparoscopic sacrocolpopex for pelvic organ prolapse: A randomized, prospective study
Scientific Title:Acronym
Comparative study of Daikenchuto and lactobacillus preparation after laparoscopic sacrocolpopexy
Region
| Japan |
Condition
Condition
pelvic organ prolapse
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of effects with Daikenchuto and lactobacillus preparation after laparoscopic surgery for pelvic organ prolapse.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Primary outcomes included time to first flatus, bowel movement, and tolerance of diet after extubation.
Key secondary outcomes
CRAD-8, VAS scale, white blood cell counts, C-reactive protein (CRP) level and length of hospital stay
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
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the intervention of Daikenchuto as the treatment of pelvic organ prolapse
Interventions/Control_2
the intervention of lactobacillus preparation as the treatment of pelvic organ prolapse
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing laparoscopic sacrocolpopexy for pelvic organ prolapse, and age > 18 years. Patients who understood the contents of this study and obtained their informed consent.
Key exclusion criteria
Patients with a history of allergy to Daikenchuto and lactobacillus preparation.
Patients who have been taking oral medications with Daikenchuto and lactobacillus preparation within the past 6 months.
In addition, patients whose physicians deem it inappropriate to participate in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Sato |
Organization
Hokusuikai Kinen Hospital
Division name
department of urology
Zip code
3100035
Address
3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
TEL
0293033003
hirotakasato911@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Sato |
Organization
Hokusuikai Kinen Hospital
Division name
department of urology
Zip code
3100035
Address
3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
TEL
0293033003
Homepage URL
hirotakasato911@yahoo.co.jp
Sponsor or person
Institute
Department of urology, Hokusuikai Kinen Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of urology, Hokusuikai Kinen Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokusuikai Kinen Hospital
Address
3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
Tel
0293033003
hirotakasato911@yahoo.co.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
| 2020 | Year | 05 | Month | 01 | 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
| 2020 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045756
| Research Plan | |
|---|---|
| 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 |
