UMIN-CTR Clinical Trial

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
Email	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
Email	hirotakasato911@yahoo.co.jp

Sponsor
Institute	Department of urology, Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization	Department of urology, Hokusuikai Kinen Hospital
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	Hokusuikai Kinen Hospital
Address	3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
Tel	0293033003
Email	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	2021 Year 05 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 04 Month 10 Day
Last modified on	2020 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045756

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.