UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051934 |
|---|---|
| Receipt number | R000059263 |
| Scientific Title | Role of robotic surgery as an element of enhanced recovery after surgery protocol in patients undergoing pancreatoduodenectomy |
| Date of disclosure of the study information | 2023/08/17 |
| Last modified on | 2023/08/17 23:40:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Role of robotic surgery as an element of enhanced recovery after surgery protocol in patients undergoing pancreatoduodenectomy
Acronym
Role of robotic surgery as an element of enhanced recovery after surgery protocol in patients undergoing pancreatoduodenectomy
Scientific Title
Role of robotic surgery as an element of enhanced recovery after surgery protocol in patients undergoing pancreatoduodenectomy
Scientific Title:Acronym
Role of robotic surgery as an element of enhanced recovery after surgery protocol in patients undergoing pancreatoduodenectomy
Region
| Japan |
Condition
Condition
patients who underwent open PD (OPD) or robotic PD (RPD)
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the role of robotic surgery as an element of the ERAS protocol in patients undergoing PD. Furthermore, we compared the clinical outcomes between open PD (OPD) and RPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the impact of ERAS items on early discharge within 3 weeks after surgery, and odds ratios (ORs) and 95% confidence intervals (CIs)
Key secondary outcomes
Patient characteristics and outcomes were investigated.
Perioperative outcomes stratified by surgical approach were compared.
The assessment of ERAS protocol compliance,
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 who underwent OPD or RPD at our institution between January 2017 and March 2023.
Key exclusion criteria
None.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-86-223-7151
kotakagi15@gmail.com
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-86-223-7151
Homepage URL
kotakagi15@gmail.com
Sponsor or person
Institute
Okayama University Hospital
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.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 | 08 | Month | 17 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059263
