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CTRI Number  CTRI/2025/07/091230 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving Recovery After Emergency Surgery: Comparing Two Ways of Patient Care 
Scientific Title of Study   Efficacy of ERAS protocol vs Conventional care in improving outcomes in patients undergoing emergency laparotomy A Randomized Controlled 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  Dr Twvisham Srivastava 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh 273008

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  7523068138  
Fax    
Email  twvishamsrivastava@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Gupta 
Designation  Associate Professor General Surgery 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh 273008

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9453302264  
Fax    
Email  ravikgmc2004@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Gupta 
Designation  Associate Professor General Surgery 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh 273008

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9453302264  
Fax    
Email  ravikgmc2004@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh India 273008 
 
Primary Sponsor  
Name  Dr Twvisham Srivastava 
Address  Department of General Surgery All India Institute of Medical Sciences Gorakhpur Kunraghat Gorakhpur Uttar Pradesh 273008 
Type of Sponsor  Other [Self] 
 
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 Twvisham Srivastava  All India Institute of Medical Sciences (AIIMS) Gorakhpur  Departmental Office Department of General Surgery First Floor, OPD Building
Gorakhpur
UTTAR PRADESH 		 7523068138

twvishamsrivastava@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, (2) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), (3) ICD-10 Condition: K561||Intussusception, (4) ICD-10 Condition: K562||Volvulus, (5) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (6) ICD-10 Condition: K251||Acute gastric ulcer with perforation, (7) ICD-10 Condition: K255||Chronic or unspecified gastric ulcer with perforation, (8) ICD-10 Condition: K261||Acute duodenal ulcer with perforation, (9) ICD-10 Condition: K265||Chronic or unspecified duodenal ulcer with perforation, (10) ICD-10 Condition: K315||Obstruction of duodenum, (11) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (12) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (13) ICD-10 Condition: K420||Umbilical hernia with obstruction,without gangrene, (14) ICD-10 Condition: K570||Diverticulitis of small intestinewith perforation and abscess, (15) ICD-10 Condition: K572||Diverticulitis of large intestinewith perforation and abscess, (16) ICD-10 Condition: K574||Diverticulitis of both small and large intestine with perforation and abscess, (17) ICD-10 Condition: K579||Diverticular disease of intestine,part unspecified, without perforation or abscess,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Care  Patients in this group will receive perioperative care according to conventional guidelines as follows Pre-operatively: Written and informed Consent Foleys catheterization and Nasogastric Tube insertion Crystalloid infusion/ resuscitation (at the discretion of surgeon) Rapid identification of physiological derangement Antibiotic prophylaxis Risk Stratification using P-POSSUM Score Intra-operatively: Anaesthesia at the discretion of the anaesthetist as per departmental protocol Regional Anaesthesia/analgesia at the discretion of the anaesthetist Routine insertion of drains Intra-operative fluid management Routine use of warmers Post-operatively: Retaining NG Tube until patient passes flatus Allowing oral sips only after the patient has passed flatus and soft diet after patient has passed stool Mobilization, CPT and Incentive Spirometry at the discretion of surgeon Removal of urinary catheters on postoperative day 3 or at the discretion of the surgeon Nausea and vomiting prophylaxis Perioperative use of steroids and discharge once patient is accepting oral feed and passing stools 
Intervention  ERAS Protocol  Patients in this group will receive perioperative care according to ERAS guidelines as follows Pre-operatively: Brief Counselling and Written Consent Rapid identification of physiological derangement Foleys catheterization and Nasogastric Tube insertion Goal directed Fluid therapy(maintaining MAP between 65 mm Hg and 90 mm Hg and urine output above 0.5 ml/kg/hour) Antibiotic prophylaxis Risk Stratification using P-POSSUM Score Intra-operatively: Selective use of drains Balanced anaesthesia with short acting drugs and regional anaesthesia in the form of epidural analgesia/blocks Strict intra-operative fluid management (GDT) Lung ventilation (low tidal volume 6-8 ml/kg, PEEP=5 cm H20) Routine use of warmers Post-operatively: Removal of NG Tube when output is less than or equal to 300 ml/day Early removal of urinary catheters(when strict fluid management isn’t required) Early mobilization, CPT and Incentive Spirometry within 24 hours of surgery Allowing oral sips after removal of NG tube on Post operative day 1 followed by liquid diet and early tube feeding if oral intake isn’t tolerated Strict fluid management (GDT) and early discontinuation of IV fluids with resumption of oral feeds Early removal of abdominal drains Post-operative nausea and vomiting prophylaxis Opioid sparing multimodal analgesia Early discharge after patient is accepting soft diet 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Adult patients aged 18 years and older
2) Patients planned for emergency laparotomy (high-risk emergency general surgical procedures) 3) Patients in whom a diagnosis has been established before surgery, and laparotomy isn’t done for diagnostic purposes
4) Patients who provide informed consent to participate in the study 
 
ExclusionCriteria 
Details  1) Patients requiring emergent intervention for complications after having undergone an elective procedure in the last 3 months
2) Patients presenting with acute trauma, as aggressive volume resuscitation is a prerequisite in both the pre- and post-operative period
3) Patients with established vital organ failure (Multiple/ Single Organ Dysfunction)
4) Pregnant females will be excluded due to potential risks to maternal and fetal health and limitations in imaging modalities
5) Patients who underwent administration of immunosuppressive agents in the past month
6) Patients with cognitive impairment or inability to provide informed consent
7) Patients who require post-operative ventilatory support or have any organ dysfunction will be excluded
8) Hollow viscus perforation (gastric/duodenal perforation) patients with perforation size more than 10 mm are excluded, as early nutrition is not feasible in these patients
9) Patients who need re-exploration after index surgery will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Early physiological recovery of the patient post operatively leading to shorter hospital stay  Primary outcome by design will be assessed at the time of discharge of patient from the facility on post operative days 3, 5 and 7 from day of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Ascertaining the incidence of failure of ERAS protocol and correlating the incidence with P-POSSUM risk stratification score.  Patients will be followed up on a daily basis in the postoperative period and 1 week and 1 month after discharge 
Comparison of the rate of post-operative complications (SSI, post operative ileus, post operative pulmonary compromise) between the two groups and quantify post operative inflammatory stress using blood markers (CRP, Albumin drop, CAR ratio)  Patients will be followed up on a daily basis in the postoperative period and 1 week and 1 month after discharge 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/07/2025 
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="2"
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   The financial and physiological stress that come with prolonged hospital stay after surgery are an ever-increasing contributor to the overall burden of disease. Post operative complications have traditionally been managed aggressively with the use of invasive monitoring and strict dietary restrictions in the immediate post-operative period in hopes to detect minute physiological disturbances and to allow time for proper healing. But the growing consensus in elective surgeries is that these measures might instead contribute to the post-surgical stress response, slowing recovery, prolonging hospital stay, with no meaningful reduction in post-operative complications beyond a certain threshold. The Early Recovery After Surgery (ERAS) society hence came up with a multi-disciplinary patient-centered approach with the idea that an early restoration of physiology and functionality of the post operative patient would foster healing and recovery leading to reduced post-operative complications and a shorter duration of hospital stay. Subsequently these guidelines were widely adapted and have become common place with most clinical practitioners all over the world. However emergency surgeries are a different story. One key differentiating factor between emergency and elective procedures is the lack of opportunity for pre-operative optimization of the patient undergoing emergency surgery. Complicating the problem is the metabolic and physiological derangement that is more often than not present in patients presenting to the Emergency Room that is expected because of the nature of the facility. The lack of proper pre-surgical nutrition and conditioning that would ordinarily be recommended to ensure the patient withstands the stress of a major open abdominal surgical procedure contributes to the high rate of intra-operative and post-operative mortality associated with patients undergoing Emergency Laparotomy (11.8 out of 100 patients will be dead by 30 days post-operatively). Given the poor optimization, increased frailty and the inherent risk associated with these life threatening intra-abdominal conditions, the ERAS society in 2023 came up with consensus guidelines for peri-operative care of patients undergoing emergency laparotomy. They propose a multi-disciplinary, structured, patient-centered approach for these patients. However, the feasibility of these guidelines has been a subject of discussion particularly in regard to the healthcare capability of middle- and low-income countries and patient compliance. The aim of this trial is to adapt and implement these guidelines in patients undergoing emergency laparotomy and to compare their efficacy, safety and feasibility with another patient group, also undergoing emergency laparotomy, managed according to the conventional approach that prioritizes invasive monitoring and strict restrictions on the functionality of the patient to reduce post-operative complications. The patients will be allocated randomly allocated to either group upon meeting the necessary inclusion and exclusion criteria. They would then receive, pre-, intra- and post operative care according to the adapted guidelines of the respective group and followed up until discharge and 1 week and 1 month after discharge for short and long term post-operative complications. The two approaches will be compared using various outcomes like duration of hospital stay, recovery of bowel function and post-operative stress quantifiers (Albumin drop, Serum CRP and CAR) The trial will take place at All India Institute of Medical Sciences (AIIMS), Gorakhpur over a span of two years. The first 18 months will be dedicated to patient recruitment, follow up and data collection. The final 6 months will be dedicated to data analysis and report writing.  
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