UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023695 |
|---|---|
| Receipt number | R000027285 |
| Scientific Title | The effectiveness and safety of perioperative Enhanced Recovery After Surgery protocol in robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System. |
| Date of disclosure of the study information | 2016/08/19 |
| Last modified on | 2016/08/19 21:10:09 |
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Basic information
Public title
The effectiveness and safety of perioperative Enhanced Recovery After Surgery protocol in robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System.
Acronym
The effectiveness and safety of perioperative ERAS protocol in robot assisted laparoscopic colorectal surgery.
Scientific Title
The effectiveness and safety of perioperative Enhanced Recovery After Surgery protocol in robot assisted laparoscopic colorectal surgery by da Vinci Si Surgical System.
Scientific Title:Acronym
The effectiveness and safety of perioperative ERAS protocol in robot assisted laparoscopic colorectal surgery.
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of perioperative ERAS protocol in robot assisted laparoscopic colorectal surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
rate of the incidence of postoperative complications further than Grade 3 of Clavien-Dindo classification ver2.0.
Key secondary outcomes
in-hospital mortality,rate of the incidence of intra-operative complications,blood loss,operative time,rate of the incidence of all postoperative complications,length of hospital stay,postoperative mobilization day,oral intake start day,first day of the gas and feces,residual urine volume in the fifth postoperative day,completion rate of clinical path
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
perioperative ERAS protocol
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
colorectal cancer
radical excision
performance status(PS;ECOG) is 0 or 1
written informed consent
Key exclusion criteria
any metastasis
the case that the high adhesion is predicted
the case that the medical attendant judged to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hiramatsu |
Organization
Toyohashi municipal hospital
Division name
department of general surgery
Zip code
Address
50 Aza Hakken Nishi Aotake-cho Toyohashi Aichi Japan
TEL
+81-532-33-6111
hiramatsu-kazuhiro@toyohashi-mh.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kisuke Ito |
Organization
Toyohashi municipal hospital
Division name
department of general surgery
Zip code
Address
50 Aza Hakken Nishi Aotake-cho Toyohashi Aichi Japan
TEL
+81-532-33-6111
Homepage URL
ito-kisuke@toyohashi-mh.jp
Sponsor or person
Institute
Toyohashi municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Toyohashi municipal hospital
Organization
Division
Category of Funding Organization
Local Government
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
豊橋市民病院 Toyohashi Municipal Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 19 | 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
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 19 | Day |
Last modified on
| 2016 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027285
