| CTRI Number |
CTRI/2023/05/052783 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study to know the Outcome of Conventional and Enhanced Recovery After Surgery(ERAS) Protocol In Patients who underwent Emergency Laparotomy |
|
Scientific Title of Study
|
A COMPARISON BETWEEN CONVENTIONAL AND ENHANCED RECOVERY AFTER SURGERY(ERAS) PROTOCOL IN CASES OF EMERGENCY LAPAROTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SMITA PAWAR |
| Designation |
JUNIOR RESIDENT-1(ACADEMIC) |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Sheikhpura Patna |
| Address |
Department of General Surgery,Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar-800014
Patna
BIHAR
800014
India |
| Phone |
8762945136 |
| Fax |
|
| Email |
sushmasmita.1318@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIBHUTI BHUSHAN |
| Designation |
PROFESSOR |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna |
| Address |
Department of General Surgery Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
9801294830 |
| Fax |
|
| Email |
drvibhuti.bhusan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SMITA PAWAR |
| Designation |
JUNIOR RESIDENT-1 (ACADEMIC) |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Sheikhpura,Patna,Bihar-800014 |
| Address |
Department of General Surgery, Indira Gandhi Institute of Medical Sciences,Sheikhpura, Patna,Bihar-800014
Patna
BIHAR
800014
India |
| Phone |
8762945136 |
| Fax |
|
| Email |
sushmasmita.1318@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna,Bihar-800014 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute Of Medical Sciences, Patna |
| Address |
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar-800014 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VIBHUTI BHUSHAN |
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna |
Department of General Surgery
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna,Bihar-800014
Patna
BIHAR |
9801294830
drvibhuti.bhusan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients with Acute Abdomen Undergoing Conventional Protocol Implementation |
Conventional protocol will be implemented on Subjects in Control group. |
| Intervention |
Patients with Acute Abdomen undergoing ERAS Protocol Implementation |
Patients undergoing Emergency Laparotomy for Acute Abdomen are study participants.All participants will be initially interviewed with pre-designed and pretested proforma.Then ERAS Protocol which includes early removal of Nasogastric tube,Catheters,Drains and early feeding and early discharge ,will be implemented on Intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-65 years,presenting with Acute Abdomen,falling under ASA(American Society of Anaesthesiologists)I-II and who will give Informed Written Consent for the study |
|
| ExclusionCriteria |
| Details |
1)Patients below 16 years and above 65 years
2)With Co-morbidities like Uncontrolled Diabetes,Chronic Obstructive Pulmonary Disease(COPD),Immunocompromised and Pregnant Patients
3)Not fit for Anaesthesia according to ASA Grading
4)With Perforated Peptic Ulcer
5)With vascular pathology like Ruptured Aortic Aneurysm,Mesenteric Vascular Ischemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Duration of Hospital Stay
2)Post Operative Morbidities (Pulmonary Complications Paralytic Ileus,Post Operative Nausea and Vomiting (PONV), Surgical Site Infections (SSI)) |
ERAS Implementation might reduce Duration of Hospital Stay and Post Operative Morbidities (Pulmonary Complications Paralytic Ileus,Post Operative Nausea and Vomiting (PONV), Surgical Site Infections (SSI)) which will be assessed at baseline and during hospital stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Post Operative Pain score and Requirement Of Analgesia
2)Re-exploration rate
3)Re-admission rate |
ERAS Implementation might reduce the post operative pain and need for Re-exploration and re-admission |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2023 |
| Date of Study Completion (India) |
10/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
MAEDICA – a Journal of Clinical Medicine
https://doi.org/10.26574/maedica.2025.20.3.615
A Journal of Clinical Medicine, Volume 20, No. 3, 2025
2025; 20(3): 615-xxx |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
TITLE-"A COMPARISON BETWEEN CONVENTIONAL AND ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN CASES OF EMERGENCY LAPAROTOMY."
INTRODUCTION-Modern Understanding of the Metabolic Response to Surgical Injury and the Mediators involved has led to a complete reappraisal of traditional post operative care and the process is known as ERAS. AIM:To Evaluate the Role and Benefit of ERAS Implementation in Patients undergoing Emergency Laparotomies. OBJECTIVES:1)To Systematically Evaluate and Compare the effect of ERAS vs Conventional Method in the Patients Undergoing Exploratory Laparotomy with respect to pre,intra and post operative Parameters 2)To Evaluate the Safety and Efficacy of ERAS Protocol in patients undergoing Emergency Laparotomy.
Methodology-The Study design is a Single Blinded, Prospective Randomized Controlled Study.The Study Setting is Indira Gandhi Institute of Medical Sciences(IGIMS),Patna.The Study will be carried out for a period of 24 Months.The Sample Size has been calculated to be 78(39 in Intervention Arm and 39 in Control Arm).Patients aged between 18-65 years,with Acute Abdomen,falling under ASA Grading I-II and who gave Informed Written Consent for the Study form the Inclusion Criteria.Patients below 18 and above 65 years,with Co-morbidities like Uncontrolled Diabetes, Chronic Obstructive Pulmonary Disease (COPD), Immunocompromised and Pregnant Patients, Not fit for Anaesthesia according to ASA Grading,with Perforated Peptic Ulcer,With vascular pathology like Ruptured Aortic Aneurysm,Mesenteric Vascular Ischemia form the Exclusion Criteria.Simple Random Sampling will be done to select the list of Participants from IPD Register at IGIMS,Patna.Then the Subjects will be Randomized into Intervention group and Control group by Simple Randomization Technique.Upon Admission,the participants allocated to both the arms will first be interviewed with the pre-designed and pretested proforma.The Intervention Arm will be subjected to ERAS Protocol and Control Arm will be subjected to Conventional Protocol.The same participants in both arm will then be assessed with respect to Duration of Hospital Stay(DHS),Post Operative Morbidities.
IMPLICATION-The Results of this study will provide important insight into the benefit and effectiveness of ERAS Implementation in Emergency Laparotomy cases resulting in decreased DHS and Post Operative Morbidities in turn resulting in Cost Effective Treatment. |