UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026076 |
|---|---|
| Receipt number | 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 23:09:16 |
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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
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
kmatsuda@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029960
