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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026076
Receipt No. R000029960
Scientific Title Analysis of pelvic drain after rectal resection for rectal cancer
Date of disclosure of the study information 2017/02/09
Last modified on 2017/02/09

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Basic information
Public title Analysis of pelvic drain after rectal resection for rectal cancer
Acronym Is pelvic drain useful after rectal resection?
Scientific Title Analysis of pelvic drain after rectal resection for rectal cancer
Scientific Title:Acronym Is pelvic drain useful after rectal resection?
Region
Japan

Condition
Condition rectal tumor
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the importance of pelvic drain
after rectal resection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of pelvic sepsis
Key secondary outcomes Asseeement of pain vy using VAS scale

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients after rectal resection with anastomosis
Key exclusion criteria Patients without anastomosis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Matsuda
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0613
Email kmatsuda@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Matsuda
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera Wakayama
TEL 073-441-0613
Homepage URL
Email kmatsuda@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 02 Month 09 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 02 Month 09 Day
Last modified on
2017 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029960

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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