A Comparative Study to know the Outcome of Conventional and Enhanced Recovery After Surgery(ERAS) Protocol In Patients who underwent Emergency Laparotomy

Completed

Conditions: Other and unspecified intestinal obstruction,

Registration Number: CTRI/2023/05/052783

Lead Sponsor: Indira Gandhi Institute Of Medical Sciences, Patna

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 78

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Duration of Hospital Stay	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
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 Measures

Name	Time	Method
1)Post Operative Pain score and Requirement Of Analgesia	2)Re-exploration rate

Trial Locations

Locations (1): Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
🇮🇳
Patna, BIHAR, India
Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
🇮🇳Patna, BIHAR, India
DR VIBHUTI BHUSHAN
Principal investigator
9801294830
drvibhuti.bhusan@gmail.com