MedPath

Enhanced Recovery After Cholecystectomy

Not Applicable
Completed
Conditions
Cholelithiases
Interventions
Other: ERAS Protocol
Registration Number
NCT06339437
Lead Sponsor
Children Hospital and Institute of Child Health, Lahore
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ERAS groupERAS ProtocolERAS protocol applied in this group
Primary Outcome Measures
NameTimeMethod
PONV24 hours

post op nausea and vomiting measured

Visual Analogue Scale score24 hours

pain assessed by visual analogue scale and higher score means worse outcome and less score means better outcome

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Children Hospital

🇵🇰

Lahore, Punjab, Pakistan

© Copyright 2025. All Rights Reserved by MedPath