FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062587 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 08/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   patients undergoing lapratomy following trauma will be subjected randomly to ERAS protocol or conventional protocol and their recovery will be assessed 
Scientific Title of Study   Enhanced recovery after surgery(ERAS) vs. standard care in patients undergoing emergency laparotomy following trauma: a randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Sharma 
Designation  junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  department of surgery, jipmer

Pondicherry
PONDICHERRY
605006
India 
Phone  8807954780  
Fax    
Email  dpakshrma28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suresh kumar S 
Designation  professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  department of surgery, jipmer


PONDICHERRY
605006
India 
Phone  8807954780  
Fax    
Email  drsureshkumar08@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Deepak Sharma 
Designation  junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  department of surgery, jipmer


PONDICHERRY
605006
India 
Phone  8807954780  
Fax    
Email  dpakshrma28@gmail.com  
 
Source of Monetary or Material Support  
department of surgery, jipmer, gorimedu, puducherry 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER  
Address  DHANVANTRI NAGAR, GORIMEDU, PUDUCHERRY 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DEEPAK SHARMA  jawaharlal institute of postgraduate medical education and research   DEPARTMENT OF SURGERY, JIPMER,GORIMEDU PONDICHERRY
Pondicherry
PONDICHERRY 
8807954780

dpakshrma28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Enhanced recovery after surgery protocol  patients undergoing emergency laparotomy following trauma will be subjected to ERAS protocol 
Comparator Agent  Patients undergoing emergency laparotomy following trauma receiving standard care. Duration of study 2 years  patients who underwent emergency laparotomy after trauma will be subjected to routine standard care. Duration of study 2 years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA (American Society of Anesthesiologists) physical status I and II
2. Adequate cognitive capacity
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Length of hospitalization  Length of hospitalization 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first flatus and stools  hospitalization 
2. Time to removal of drainage tubes (nasogastric tube, urinary catheter, abdominal drainage tube)  hospitalization 
Time to resumption of oral feeds (fluids and solid diet)  hospitalization 
Need for Nasogastric tube insertion  hospitalization 
Need for additional intravenous opiod analgesics  hospitalization 
Complications (Measured by Clavien-Dindo classification)  hospitalization 
30 days Mortality and readmission rates  30days postop 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Trauma is increasing at an alarming rate. In India alone, it is estimated that one million people die and 20 million are hospitalized every year due to injuries4. Besides the burden of disease attributes to prolonged hospital stay and delayed return to routine activities5.

 

An institutional study done by Mohammad Gad et al, had shown higher incidence of blunt trauma abdomen among trauma patients of 69.4% with around 28.3 % requiring surgical intervention6. An Indian based study also has shown higher incidence of abdominal trauma of about 73 %7. Added to this the post operative care of trauma patients undergoing surgery is of varied complexity attributed to wide range of pain manifestation and analgesics, complications due to other injuries, bleeding, nutrition, immobilization, high risk of thromboembolic events8.

Patients presenting at emergency department need varied services according to their condition at presentation which may range from hemodynamically stable to patients with failure and shock. Majority of deaths in blunt trauma is as a result of secondary hypovolemic shock due to intraperitoneal bleed which occur in 12% of patients9. Therefore, it is essential to identify trauma quickly.  FAST (focused assessment with sonography in trauma) had evolved as an noninvasive tool in place of diagnostic peritoneal lavage as a preliminary investigative step to assess the intra peritoneal pathology due to trauma especially in unstable patients10. Contrast enhanced CT is more definitive to evaluate blunt trauma, in relatively stable patients11. The objective is rapid identification of those patients who need a laparotomy.

Evaluation of blunt trauma abdomen starts from stabilization of the patients followed by the assessment. Clinical assessment of patients with blunt abdominal trauma is often difficult and can be inaccurate. The most reliable signs and symptoms in alert patients are Pain, Tenderness, Gastrointestinal haemorrhage, hypovolemia, evidence of peritoneal irritation. Besides on physical examination, the following injury patterns predict the potential for intra-abdominal trauma include marks and contusions, ecchymosis, abdominal distension, local or generalised tenderness, guarding and rigidity or rebound tenderness, fullness on palpation, crepitations or instability of lower thoracic cage12.

Patients who are haemodynamically decompensated with a positive Focused Assessment with Sonography for Trauma (FAST) should proceed directly to a trauma laparotomy to stop major abdominal bleeding and, if applicable, other sources of bleeding (e.g., pelvic, or long bone fractures), as well as control spillage of intestinal contents. To emphasise that time is a crucial factor that with every 3 min spent in the emergency department equate to a 1% increased death probability and as a result of which trauma laparotomies tend to be mandated based on quality assessment13

The various classifications used to grade the severity of the injured organs with the organ injury scale include the American Association for the Surgery of Trauma (A. A. S. T.) 14, World society of emergency surgery (WSES) grading13,

The various surgical procedures commonly performed in abdominal surgery due to trauma include splenectomy, partial resection of the liver, vascular repair, resection and anastomosis of bowel, colostomy, distal pancreatectomy, and nephrectomy. The most frequent postoperative morbidities related to blunt abdominal trauma in the patients who survived the initial operation were prolonged ventilatory support, high dose analgesics including opioids, nil per oral, strict bed rest, prolonged urinary catheterization, central and peripheral vascular access, multiple blood transfusions and associated transfusion reactions, wound infection, pulmonary infection, intra-abdominal abscesses, pancreatitis15.

 Various modalities are being under study to improve quality care among patients undergoing trauma surgery. ERAS is one such quality care protocol under wide use in elective surgical procedures and have been shown to lead to a reduction in hospital stay, complications and earlier resumption of normal activities16.

There is well documented evidence in the literature regarding applicability of ERAS pathways in elective bowel surgeries and have been shown to lead to a reduction in hospital stay, complications and earlier resumption of normal activities.

Multiple RCTs and meta-analysis have been done supporting the fact that in patients undergoing elective bowel surgery, early feeding is safe, well tolerated and decreases the hospital stay.

In a study done by V Purushothaman et al have shown that ERAS is safe and feasible in trauma surgery with similar complication rate. There are no other similar studies to the best of our knowledge17. Hence, this study is being done to investigate role of ERAS in emergency abdominal surgeries due to trauma. 
Close