UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039897 |
|---|---|
| Receipt number | R000044542 |
| Scientific Title | Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection. |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2021/09/22 21:09:45 |
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Basic information
Public title
Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Acronym
Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Scientific Title
Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Scientific Title:Acronym
Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze required times of surgical process in detail especially bleeding and hemostasis from surgery video in patients who performed laparoscopic low anterior resection for rectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of working hours associated with bleeding in laparoscopic operation
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
For patients who meet all of the following criteria.
1) 20 years or older at surgical time with no age limit.
2) Regardless of gender.
3) Patients who underwent laparoscopic low anterior resection for rectal cancer diagnosed adenocarcinoma pathologically.
4) Regardless with or without distant metastasis.
5) Regardless with or without preoperative therapy (chemotherapy, radiotherapy, chemoradiotherapy).
Key exclusion criteria
Exclude patients who meet any of the following criteria.
1) Emergency surgery cases.
2) Patients determined to be inappropriate by the doctor's judgement.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama city, Kanagawa prefecture, Japan
TEL
045-261-5656
nabe-jun@comet.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Goto |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama city, Kanagawa prefecture, Japan
TEL
045-261-5656
Homepage URL
kouki_go_to@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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 Center for Novel and Exploratory Clinical Trials
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa prefecture, Japan
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
| 2020 | Year | 03 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044542
