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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024908
Receipt No. 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

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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
Email 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
Email hayashi.kentaro@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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