UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024908 |
|---|---|
| Receipt number | R000028567 |
| Scientific Title | Randomized controlled trial on the effect of coffee on postoperative ileus after laparoscopic ventral rectopexy |
| Date of disclosure of the study information | 2016/11/21 |
| Last modified on | 2016/11/19 13:13:25 |
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Basic information
Public title
Randomized controlled trial on the effect of coffee on postoperative ileus after laparoscopic ventral rectopexy
Acronym
Coffee study
Scientific Title
Randomized controlled trial on the effect of coffee on postoperative ileus after laparoscopic ventral rectopexy
Scientific Title:Acronym
Coffee study
Region
| Japan |
Condition
Condition
postoperative ileus
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the effect of coffee with water on postoperative ileus after laparoscopic ventral rectopexy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total number of evacuated radiopaque markers 26h after administration of a radiopaque marker capsule (SITZMARKS) for the total transit analysis
Key secondary outcomes
Segmental transit analysis of the number of radiopaque markers in the following 5 locations, stomach, small intestine, right colon, left colon and rectum 6h, 26h, 50h and 74h after administration of a radiopaque marker capsule (SITZMARKS) and time to the first flatus and defecation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Coffee
Interventions/Control_2
warm water
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
The patients with either rectal intussusception or external rectal prolapse being scheduled to taking laparoscopic ventral rectopexy
Key exclusion criteria
(1) had slow transit constipation; (2) dislikes coffee or was allergic to coffee; (3) thought to be hard to complete laparoscopic surgery; (4) classified into American Society of Anesthesiologists Physical Status Classification System (ASA-PS) IV or V; (5) had central neural dysfunction or peripheral neuropathy; (6) younger than 20 years old; or (7) had intraoperative injury
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tsunoda |
Organization
Kameda Medical Center
Division name
Gastrointestinal surgery
Zip code
Address
929, Higashi-Cho, Kamogawa-Shi, Chiba, Japan
TEL
04-7092-2211
tsunoda.akira@kameda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Hayashi |
Organization
Kameda Medical Center
Division name
Gastrointestinal surgery
Zip code
Address
929, Higashi-Cho, Kamogawa-Shi, Chiba, Japan
TEL
04-7092-2211
Homepage URL
hayashi.kentaro@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | Month | 21 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028567
