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NCT Number: NCT06339437

Enhanced Recovery After Cholecystectomy

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERAS Protocol

Other

Ehanced recovery after surgery protocols were applied

Primary outcomes

  1. PONV

    Time frame: 24 hours

    post op nausea and vomiting measured

  2. Visual Analogue Scale score

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Children Hospital and Institute of Child Health, Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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