UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047204 |
|---|---|
| Receipt number | R000053843 |
| Scientific Title | Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2022/03/17 19:31:53 |
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Basic information
Public title
Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Acronym
Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Scientific Title
Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Scientific Title:Acronym
Examination of the safety of intracorporeal anastomosis for colon cancer using lavage cytology
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the presence or absence of tumor cell dispersal during intracorporeal anastomosis and prove that the intracavitary anastomosis is a safe procedure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of tumor cells in cytology of intraperitoneal lavage water before and after intracorporeal anastomosis and lavage water for stapler
Key secondary outcomes
Evaluation of recurrence (peritoneal dissemination, local recurrence) 3 years after surgery
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 diagnosed with colon cancer after undergoing colonoscopy
2.Patients who are judged to be appropriate for treatment by laparoscopic surgery.
3.Patients aged 20 years or older at the time of consent acquisition.
4.Patients who received sufficient explanation in participating in this study, and obtained written consent by the patient's free will after sufficient understanding.
Key exclusion criteria
1. Patients reconstructed using circular stapler
2. Patients with peritoneal dissemination.
3. Patients with conversion to open surgery.
4. Other patients who are deemed by the attending physician to be unable to participate in the research.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Eguchi |
Organization
Nagasaki university hospital
Division name
Department of Surgery
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Adachi |
Organization
Nagasaki university hospital
Division name
Department of Surgery
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-819-7316
Homepage URL
t-adachi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 18 | 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
| 2022 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053843
