Clinical trial NCT06339437: Enhanced Recovery After Cholecystectomy
Official title: Enhanced Recovery After Surgery (ERAS) Protocol Does Early Implementation Improve The Outcome For Elective Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiases
Keywords: ERAS
GALL STONE DISEASE
LAPAROSCOPIC CHOLECYSTECTOMY
Lead sponsor: Children Hospital and Institute of Child Health, Lahore
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ERAS protocols applied
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PONV
timeFrame: 24 hours
measure: Visual Analogue Scale score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The Children Hospital
state: Punjab
Study officials:
affiliation: Consultant Surgeon
name: Adeel A Gujjar, M.S
role: PRINCIPAL_INVESTIGATOR
References: