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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000040129 |
Receipt No. | 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 | 2020/05/11 |
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 |
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Condition | ||
Condition | pelvic organ prolapse | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Last modified on |
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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 |