UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050923 |
|---|---|
| Receipt number | R000058032 |
| Scientific Title | A multicenter observational study to verify the validity of introducing robotic surgery in patients with colorectal cancer after the surgeon obtains the certification of laparoscopic skilled surgeon in Japan |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2024/10/24 19:19:11 |
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Basic information
Public title
A multicenter observational study to verify the validity of introducing robotic surgery in patients with colorectal cancer after the surgeon obtains the certification of laparoscopic skilled surgeon in Japan
Acronym
Evaluation of the validity of starting robotic surgery after obtaining laparoscopic technical certification in colorectal cancer.
Scientific Title
A multicenter observational study to verify the validity of introducing robotic surgery in patients with colorectal cancer after the surgeon obtains the certification of laparoscopic skilled surgeon in Japan
Scientific Title:Acronym
A multicenter observational study to verify the validity of introducing robotic surgery in patients with colorectal cancer after the surgeon obtains the certification of laparoscopic skilled surgeon in Japan
Region
| Japan |
Condition
Condition
Sigmoid colon cancer and rectosigmoid colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In Japan, an objective evaluation system for quality of conventional laparoscopic surgery by the Japan Society for Endoscopic Surgery (JSES) has been introduced since 2003, contributing to the improvement of surgical skills of young surgeons. We aimed to determine how the certification of skilled surgeon of laparoscopic surgery is related to surgical outcomes when robotic colorectal surgery is initiated.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative complication rate
Key secondary outcomes
Operative time, blood loss, insufflation time, console time, survival rate, and time required for each part of the procedure (dissection, medial to lateral approach, rectal mobilization, mesorectal incision, and rectal resection)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of patients diagnosed with sigmoid colon cancer or sigmoid rectum cancer between January 2021 and March 2023
1) Patients who underwent primary resection for sigmoid colon cancer or sigmoid rectal cancer
2) Patients who underwent laparoscopic surgery or robotic surgery
3) Patients who were 18 years of age or older at the time of surgery
4) Patients who were operated on by surgeons who newly obtained certification of Endoscopic Surgical Skill Qualification System by JSES during the subject period.
Key exclusion criteria
1) Patients diagnosed with colitic cancer
2) Patients who underwent colorectal resection of other parts of the body at the same time
3) Other patients who are deemed by the treating physician to be ineligible to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Numata |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama-shi, 232-0024, Japan
TEL
045-261-5656
numata@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Iguchi |
Organization
Yokohama City University Medical Center
Division name
Department of Surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku, Yokohama-shi, 232-0024, Japan
TEL
045-261-5656
Homepage URL
iguchi.ken.vn@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
Y-NEXT
Address
1-1-1, Fukuura, kanazawa-ku, Yokohama-shi
Tel
045-370-7933
ynext@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
| 2023 | Year | 04 | Month | 25 | 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
77
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
| 2023 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter observational study
Management information
Registered date
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058032
