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Enhanced Recovery After Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06339437
Enrollment
60
Registered
2024-04-01
Start date
2023-04-01
Completion date
2023-11-01
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiases

Keywords

ERAS, GALL STONE DISEASE, LAPAROSCOPIC CHOLECYSTECTOMY

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.

Interventions

OTHERERAS Protocol

Ehanced recovery after surgery protocols were applied

Sponsors

Children Hospital and Institute of Child Health, Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

outcomeassessor was not told about group allocation

Intervention model description

ERAS protocols applied

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PONV24 hourspost op nausea and vomiting measured
Visual Analogue Scale score24 hourspain assessed by visual analogue scale and higher score means worse outcome and less score means better outcome

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026