Enhanced Recovery After Cholecystectomy

Enhanced Recovery After Surgery (ERAS) Protocol Does Early Implementation Improve The Outcome For Elective Laparoscopic Cholecystectomy Surgery

this study will be conducted involving patients of all genders between the ages of 20 and 60 years who will undergo elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease. The study will be conducted in Department of West Surgical Ward, Mayo Hospital, Lahore, after receiving approval from the hospital's Ethical Committee. Patients having other co-morbid conditions, pregnant patients, and those undergoing laparoscopic cholecystectomy converted to open surgery will be excluded from the study. LFTs and other baseline investigations will be done routinely of every patient. Written informed consent will be obtained from all the patient. Patients will be divided into two groups with 30 patients in each group. Group A will consist of patient in whom ERAS protocol will be implemented and Group B in whom ERAS protocol will not be implemented.

Study Overview

• Status: Completed
• Conditions: Cholelithiases
• Intervention / Treatment: Other: ERAS Protocol

Detailed Description

INTRODUCTION: Gallstone disease is most frequent gastrointestinal problems. Gallbladder stone formation can cause discomfort in the upper abdomen. The gallbladder is surgically removed by keyhole surgery, a process known as laparoscopic cholecystectomy, to address this problem. The enhanced recovery after surgery (ERAS) program applies evidence based perioperative interventions that, collectively, reduce morbidity and length of hospital stay METHODOLOGY: A study will be conducted involving patients of all genders between the ages of 20 and 60 years who will undergo elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease. The study will be conducted in Department of West Surgical Ward, Mayo Hospital, Lahore, after receiving approval from the hospital's Ethical Committee. Patients having other co-morbid conditions, pregnant patients, and those undergoing laparoscopic cholecystectomy converted to open surgery will be excluded from the study. LFTs and other baseline investigations will be done routinely of every patient. Written informed consent will be obtained from all the patient. Patients will be divided into two groups with 30 patients in each group. Group A will consist of patient in whom ERAS protocol will be implemented and Group B in whom ERAS protocol will not be implemented.

All patients were demonstrated about use of the VAS score. Duration of analgesia was recorded and additional requirement for analgesia was noted. Post-operative side effects i.e. nausea, vomiting, sedation and shivering were noted. Post-operative hospital stay was also noted. All data were noted and analyzed in to SPSS v25.0. Independent t-test was applied for the comparison of mean post-operative duration of analgesia and mean post-operative pain score between two groups taking p-value ≤0.05 as significant.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 42000
      • The Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Ages between 20 to 60 years

  • All genders included
  • ASA class I and II
  • Undergoing elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease.

Exclusion Criteria:

• Patients having other co-morbid conditions like uncontrolled diabetes (BSR>300) and uncontrolled hypertension (Blood Pressure>180/110).
• Previous abdominal surgery documented previous medical records.
• Pregnant patients documented on history
• Those undergoing laparoscopic cholecystectomy converted to open surgery proved by per-operative findings
• Immunocompromised patients documented on previous medical records.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS group; ERAS protocol applied in this group	Other: ERAS Protocol; Ehanced recovery after surgery protocols were applied
No Intervention: non ERAS group; conventional method of post op care was used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV	post op nausea and vomiting measured	24 hours
Visual Analogue Scale score	pain assessed by visual analogue scale and higher score means worse outcome and less score means better outcome	24 hours

Collaborators and Investigators

• Sponsor: Children Hospital and Institute of Child Health, Lahore
• Investigators: Principal Investigator: Adeel A Gujjar, M.S, Consultant Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ERAS; GALL STONE DISEASE; LAPAROSCOPIC CHOLECYSTECTOMY
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: Adeel3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No