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Enhanced Recovery After Cholecystectomy

C

Children Hospital and Institute of Child Health, Lahore

Status

Completed

Conditions

Cholelithiases

Treatments

Other: ERAS Protocol

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

ERAS group
Experimental group
Description:
ERAS protocol applied in this group
Treatment:
Other: ERAS Protocol
non ERAS group
No Intervention group
Description:
conventional method of post op care was used

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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