UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049516 |
|---|---|
| Receipt number | R000056364 |
| Scientific Title | Assessment for feasibility and outcomes of ERAS protocol following abdominal surgeries in trauma patients |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2022/11/15 18:45:16 |
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Basic information
Public title
ERAS protocol in trauma patients undergoing abdominal surgeries
Acronym
ERASTAS
Scientific Title
Assessment for feasibility and outcomes of ERAS protocol following abdominal surgeries in trauma patients
Scientific Title:Acronym
ERASTAS
Region
| Asia(except Japan) |
Condition
Condition
Trauma patients undergoing abdominal surgery
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of feasibility of ERAS protocol (follow up period 30 days)
Basic objectives2
Others
Basic objectives -Others
Length of hospitalisation, duration of removal of catheters, time for passage of first stool and flatus, 30-day morbidity and mortality rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of feasibility of ERAS protocol (follow up period 30 days)
Key secondary outcomes
Length of hospitalisation, duration of removal of catheters, time for passage of first stool and flatus, 30-day morbidity and mortality rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Interventions (arm 1)- Early removal of Ryle tube, early removal of urinary catheter, early removal of intra-operative drain, early ambulation, early initiation of diet, use of opioid-sparing multimodal analgesia
Interventions/Control_2
Control (arm 2)- Removal of Ryle tube, urinary catheter, intra-operative drain as per physician's decision, use of conventional opioid analgesia, ambulation and diet initiation as per the physician's decision
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Blunt/penetrating trauma abdomen patients undergoing abdominal surgery
Key exclusion criteria
Polytrauma cases with other associated severe injuries
Long bone fracture of lower limb
Patients requiring mechanical ventilation or vasopressors more than 24 hours post-surgery
Pelvic fracture, Urinary bladder or urethral injury
Primary surgery performed elsewhere
Pancreatic injury
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Vibhu |
| Middle name | |
| Last name | Jain |
Organization
Post Graduate Institute of Medical Education and Research
Division name
General surgery
Zip code
160012
Address
Department of General Surgery, 5th floor, Nehru building, PGIMER, sector 12, chandigarh
TEL
0172-2756624
jainvibhu26@gmail.com
Public contact
Name of contact person
| 1st name | Kailash |
| Middle name | Chand |
| Last name | Kurdia |
Organization
Post Graduate Institute of Medical Education and Research
Division name
General surgery
Zip code
160012
Address
Department of General Surgery, 5th floor, Nehru building, PGIMER, sector 12, chandigarh
TEL
0172-2756624
Homepage URL
drkurdia@gmail.com
Sponsor or person
Institute
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Institute Ethics Committee, Post Graduate Institute of Medical Education and Research
Address
Institutional ethics committee, Room no 6006, sixth floor research block B, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Tel
0172-2755266
iecpgi@gmail.com
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
| 2022 | Year | 11 | Month | 15 | 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
| 2021 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056364
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
