UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035017 |
|---|---|
| Receipt number | R000039928 |
| Scientific Title | Retrospective study of postoperative management of robot-assisted rectal resection performed at our hospital |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2018/11/27 10:45:02 |
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Basic information
Public title
Retrospective study of postoperative management of robot-assisted rectal resection performed at our hospital
Acronym
postoperative management of robot-assisted rectal resection
Scientific Title
Retrospective study of postoperative management of robot-assisted rectal resection performed at our hospital
Scientific Title:Acronym
postoperative management of robot-assisted rectal resection
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify postoperative condition and recovery of robot-assisted rectal resection in a retrospective manner
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative pain (postoperative day 0-2)
pain scale
dose of analgesics
Key secondary outcomes
Recovery of bowel function (postoperative day 0-2)
peristaltic sound
postoperative nausea and vomiting
Peripheral neuropathy
postoperative delirium
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients underwent robot-assisted rectal resection under general anesthesia at our hospital from March 1, 2014 to September 30, 2018
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo medical university school of medicine
Division name
Department of anesthesiolgy
Zip code
Address
S1 W16, Chuo-ku, Sapporo, 060-8556, Japan
TEL
011-611-2111(35680)
niiyama@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo medical university school of medicine
Division name
Department of anesthesiolgy
Zip code
Address
S1 W16, Chuo-ku, Sapporo, 060-8556, Japan
TEL
011-611-2111(35680)
Homepage URL
niiyama@sapmed.ac.jp
Sponsor or person
Institute
Department of anesthesiolgy, Sapporo medical university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiolgy, Sapporo medical university school of medicine
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
Address
Tel
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
| 2018 | Year | 11 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We clarify the postoperative state and recovery of bowel function after robot-assisted rectal resection at our hospital in a retrospective manner and feed back for better perioperative management.
Management information
Registered date
| 2018 | Year | 11 | Month | 27 | Day |
Last modified on
| 2018 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039928
