Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339437
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2024-03-25
Brief Title:
Enhanced Recovery After Cholecystectomy
Sponsor:
Children Hospital and Institute of Child Health Lahore
Organization:
Children Hospital and Institute of Child Health Lahore
Study Overview
Official Title:
Enhanced Recovery After Surgery ERAS Protocol Does Early Implementation Improve The Outcome For Elective Laparoscopic Cholecystectomy Surgery
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hospitals 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 hospitals 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 ie nausea vomiting sedation and shivering were noted Post-operative hospital stay was also noted All data were noted and analyzed in to SPSS v250 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 005 as significant
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 ie nausea vomiting sedation and shivering were noted Post-operative hospital stay was also noted All data were noted and analyzed in to SPSS v250 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 005 as significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None