UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030434 |
|---|---|
| Receipt number | R000034293 |
| Scientific Title | Clinical value of the cytokine levels in the postoperative drainage fluid for outcome in patients with colorectal diseases after open surgery and laparoscopic surgery |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2021/09/10 16:03:43 |
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Basic information
Public title
Clinical value of the cytokine levels in the postoperative drainage fluid for outcome in patients with colorectal diseases after open surgery and laparoscopic surgery
Acronym
Clinical value of the cytokine levels in the postoperative drainage fluid for outcome in patients with colorectal diseases after open surgery and laparoscopic surgery
Scientific Title
Clinical value of the cytokine levels in the postoperative drainage fluid for outcome in patients with colorectal diseases after open surgery and laparoscopic surgery
Scientific Title:Acronym
Clinical value of the cytokine levels in the postoperative drainage fluid for outcome in patients with colorectal diseases after open surgery and laparoscopic surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to disclose the clinical values of cytokine levels (TGF-b, FGF, TNF-a, HGF etc) in the postoperative drainage fluid and serum for outcome (complications, recurrence) in patients with colorectal diseases after open surgery and laparoscopic surgery.
Basic objectives2
Others
Basic objectives -Others
To disclose the difference of cytokine levels between open surgery and laparoscopic surgery.
To disclose the relationship between mRNA levels of cytokines in the peritoneal tissues and the cytokine levels in the postoperative drainage fluid/serum.
To disclose the difference of mRNA levels of cytokines in the peritoneal tissues between open surgery and laparoscopic surgery.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between the cytokine levels in the postoperative drainage fluid/serum and the rates of postoperative complications (obstruction etc) or recurrence
Key secondary outcomes
Association between the surgical procedures and the cytokine levels in the postoperative drainage fluid/serum.
Association between the mRNA levels in peritoneal tissues and the cytokine levels in the postoperative drainage fluid/serum .
Association between the surgical procedures and the mRNA levels in peritoneal tissues.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who will undergo bowel resecrion of left-side colon or rectum for malignant or benign diseases.
(2) Age:>= 20 years
(3) Written IC with date
Key exclusion criteria
Patients judged inappropriate for this study by the physicians
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ueno |
Organization
National Defense Medical College
Division name
Surgery
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama
TEL
04-2995-1511
shinto@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shinto |
Organization
National Defense Medical College
Division name
Surgery
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama
TEL
04-2995-1511
Homepage URL
shinto@ndmc.ac.jp
Sponsor or person
Institute
Department of surgery, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of surgery, National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
3-2 Namiki Tokorozawa Saitama
Tel
04-2995-1511
shinto@ndmc.ac.jp
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
防衛医科大学校病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective observational study started in 2011 to reveal the relationship between the cytokine levels in the drainage fluid and postoperative complications (obstruction etc) and the difference of cytokine levels between open surgery and laparoscopic surgery. In 2015 we amended the study protocols and started to check the cancer recurrence to reveal the relationship between the cytokine levels and cancer recurrence in addition to the complications. This amendment has been approved by IRB and we have already informed all the patients who had been enrolled in the preceding study of the amendment.
Management information
Registered date
| 2017 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034293
