UMIN-CTR Clinical Trial

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
Email	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
Email	drkurdia@gmail.com

Sponsor
Institute	Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056364