Unique ID issued by UMIN | UMIN000031475 |
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Receipt number | R000035929 |
Scientific Title | The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2020/09/08 10:30:07 |
The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
The efficacy of Daikenchuto (TJ-100) on abdominal discomfort (pain) in patients with defecation disorders: a retrospective study
Japan |
defecation disorders
Hepato-biliary-pancreatic surgery |
Others
NO
To elucidate the improvement effect of daikenchuto on the abdominal discomfort (pain) in patients with defecation disorders by using Constipation Scoring System (CSS) etc.
Efficacy
Change in score of CSS (Constipation Scoring System) before and after administration of daikenchuto
1. Change in score of CCIS (Cleveland Clinic Incontinence Score) before and after administration of daikenchuto
2. Change in anal pressure before and after administration of daikenchuto
3. To explore the influencing factors on change in CSS, CCIS and anal pressure before and after administration of daikenchuto
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients who proceeded to be dosed daikenchuto between January 1, 2012 and December 31, 2016
2. Patient with defecation disorder
Patient without abdominal discomfort (pain) before proceeding to be dosed
200
1st name | Tatsuya |
Middle name | |
Last name | Abe |
Kunimoto Hospital
Department of Proctology
070-0061
1-7-2-1 Akebono, Asahikawa, Hokkaido
0166-25-2241
t-abe@cf6.so-net.ne.jp
1st name | Tatsuya |
Middle name | |
Last name | Abe |
Kunimoto Hospital
Department of Proctology
070-0061
1-7-2-1 Akebono, Asahikawa, Hokkaido
0166-25-2241
t-abe@cf6.so-net.ne.jp
Kunimoto Hospital
Tsumura & Co.
Profit organization
Japan
Tsumura & Co.
IRB of the Maebashi Hirosegawa Clinic
2-10-9 Chiyotamachi Maebashi-shi Gunma
027-231-4101
kaneko@smo-msr.co.jp
NO
医療法人健康会くにもと病院(北海道)
2018 | Year | 03 | Month | 01 | Day |
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_file_dl.cgi?recptno=R000035929&file_id=00001&file_kind=1
Published
https://doi.org/10.23922/jarc.2019-012
157
On the CCIS, total score was significantly improved after administration of DKT. On the CSS, no significant difference was found in the total score. On the Bristol Stool Form Scale, DKT showed a tendency to normalize stool consistency. Maximum resting anal pressure and maximum squeeze anal pressure significantly increased after the administration of DKT. No side effects caused by DKT were observed during the study.
2020 | Year | 09 | Month | 08 | Day |
A total of 157 patients who fulfilled the appropriate criteria within the study period were enrolled. Their mean age was 73.6 years old, and female patients accounted for 75%.
The type of FI was passive incontinence in 86 cases, urge incontinence in 8 cases, and passive and urge incontinence in 63 cases.
Of the subjects of this study, 45 had already used laxatives.
Patients who visited the hospital from January 2012 to December 2016 due to FI as the major complaint and were treated with DKT were included as study participants. Patients with organic disorders of the rectoanal region, such as rectal prolapse, abscess, and tumor, or who used treatment other than DKT were excluded.
As this is a retrospective observational research using existing data collected by the hospital, the written consent was not obtained from the patients in advance. Therefore, the contents of the research were posted in the hospital to inform the subjects, providing the opportunity to refuse the usage of their data in the research.
No side effects caused by DKT were observed during the study period.
Clevaland Clinic Incontinence Score
Constipation Scoring System
Bristol Stool Form Scale
Maximum resting anal pressure
Maximum squeeze anal pressure
Main results already published
2018 | Year | 01 | Month | 09 | Day |
2018 | Year | 01 | Month | 24 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 11 | Month | 28 | Day |
Retrospective study of patients who proceeded to be dosed daikenchuto between January 1, 2012 and December 31, 2016
2018 | Year | 02 | Month | 26 | Day |
2020 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035929
Research Plan | |
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Registered date | File name |
2020/09/08 | UMIN000031475_protocol.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |