UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032062
Receipt No. R000036575
Scientific Title The effect of gum chewing and/or early oral intake on bowel function recovery after surgery of gynecological cancer patients: a randomized control trial
Date of disclosure of the study information 2018/04/03
Last modified on 2018/12/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of gum chewing and/or early oral intake on bowel function recovery after surgery of gynecological cancer patients: a randomized control trial
Acronym The effect of gum chewing and/or early oral intake on bowel function recovery
Scientific Title The effect of gum chewing and/or early oral intake on bowel function recovery after surgery of gynecological cancer patients: a randomized control trial
Scientific Title:Acronym The effect of gum chewing and/or early oral intake on bowel function recovery
Region
Japan

Condition
Condition Gynecological cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Bowel function recovery after surgery of gynecological cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of ileus
Key secondary outcomes First flatus time
First defecation time

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Gum chewing
Interventions/Control_2 Non-gum chewing
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
80 years-old >=
Gender Female
Key inclusion criteria PS: 0-1
Neutrophils>2000/mm3
Hb>9.0g/dl
Plt>100000/mm3
AST,ALT<100U/L
T-Bil<1.5mg/dl
Cre<1.5mg/dl
Key exclusion criteria Bowel inflammatory disease
History of RT
Case with bowel resection
Difficulty in mastication
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soshi Kusunoki
Organization Juntendo University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Email skusuno@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Soshi Kusunoki
Organization Juntendo University Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 0338133111
Homepage URL
Email skusuno@juntendo.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine
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 順天堂大学医学部附属順天堂医院(東京都)、順天堂大学医学部附属練馬病院(東京都)、順天堂大学医学部附属浦安病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 03 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
2018 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 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
2018 Year 04 Month 02 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.