UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043987 |
|---|---|
| Receipt number | R000050238 |
| Scientific Title | Multi-center feasibility study of anastomotic leakage for right-sided colon cancer focusing on laparoscopic intracorporeal overlap reconstruction |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2023/02/16 15:19:46 |
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Basic information
Public title
Multi-center feasibility study of anastomotic leakage for right-sided colon cancer focusing on laparoscopic intracorporeal overlap reconstruction
Acronym
Multi-center feasibility study of anastomotic leakage for right-sided colon cancer focusing on laparoscopic intracorporeal overlap reconstruction
Scientific Title
Multi-center feasibility study of anastomotic leakage for right-sided colon cancer focusing on laparoscopic intracorporeal overlap reconstruction
Scientific Title:Acronym
Multi-center feasibility study of anastomotic leakage for right-sided colon cancer focusing on laparoscopic intracorporeal overlap reconstruction
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and long-term results of intracorporeal anastomosis using the overlap method for intestinal reconstruction in laparoscopic surgery for right-sided colon cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of anastomotic leakage
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with histologically proven adenocarcinoma of the cecum, ascending colon, or right transverse colon
cStage1-3
Patients scheduled to undergo laparoscopic or robotic ileoceacal resection, right hemicolectomy, or extended-right hemicolectomy
Laparoscopic or robotic Overlap method is planned as a reconstruction method.
Patients with preoperative ECOG PS 0-2
Patients aged 20 years or older at the time of enrollment
Patients who have given written consent to participate in this study.
Key exclusion criteria
Patients with a history of multiple colorectal cancer requiring surgical resection
Patients with concurrent multiple colorectal cancer requiring multiple anastomoses or resection sites
Patients scheduled to undergo simultaneous other operation.
Patients who cannot be pretreated due to preoperative bowel obstruction or severe stenosis
Preoperative gastrointestinal perforation
Pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
Patients who have psychosis or psychiatric symptoms that make it difficult to participate in the study.
Patients receiving continuous systemic administration (intravenous or intravenous) of steroids or other immunosuppressive agents.
Patients with serious comorbidities that are poorly controlled.
Patients considered inappropriate by the physician in charge.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kazama |
Organization
Yokohama city university
Division name
Departmnent of surgery
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City, Japan
TEL
0457872800
numata@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kazama |
Organization
Yokohanma city university
Division name
Departmnent of surgery
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City, Japan
TEL
0457872800
Homepage URL
kkazama@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
not aplicable
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
Yokohama City University
Address
1-1-1 Fukuura Kanazawa-ku Yokohama city, Japan
Tel
045-370-7991
rinri@yokohama-cu.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
| 2021 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
