UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050592 |
|---|---|
| Receipt number | R000057620 |
| Scientific Title | Research on clinicopathological characteristics of colorectal tumors and the efficacy and safety of treatment |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2023/03/15 14:05:03 |
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Basic information
Public title
Study on Effectiveness and Safety of Intracorporeal Anastomosis in Laparoscopic Colectomy
Acronym
Study on Effectiveness and Safety of Intracorporeal Anastomosis in Laparoscopic Colectomy
Scientific Title
Research on clinicopathological characteristics of colorectal tumors and the efficacy and safety of treatment
Scientific Title:Acronym
Research on characteristics of colorectal tumors and the efficacy and safety of treatment
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the short-term outcomes of patients who undergo intracorporeal anastomosis during laparoscopic colectomy and compare them to those of patients undergoing extracorporeal anastomosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of overall postoperative complications
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients who underwent elective laparoscopic colectomy for benign or malignant tumor located from the appendix to the descending colon at the splenic flexure at the NCCHE between January 2018 and June 2021
Key exclusion criteria
Patients who underwent simultaneous resection of other organs and those with no anastomosis were excluded. Sigmoid colectomy and rectal resections requiring IA with the double stapling technique were also excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Ito |
Organization
National Cancer Center Hospital East
Division name
Department of Colorectal Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
TEL
04-7133-1111
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Teramura |
Organization
Hokkaido University Faculty of Medicine
Division name
Department of Gastroenterological Surgery II
Zip code
060-8638
Address
Kita 15-jo, Nishi 7-chome, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7714
Homepage URL
terakou3@gmail.com
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
non
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
National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
Tel
04-7133-1111
maito@east.ncc.go.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
| 2023 | Year | 03 | Month | 15 | 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
325
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is retrospective single-center cohort study
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057620
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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