Enhanced Recovery After Cholecystectomy

NCT ID: NCT06339437

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-11-01

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.

Conditions

Cholelithiases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

ERAS group

ERAS protocol applied in this group

Group Type: EXPERIMENTAL

ERAS Protocol

Intervention Type: OTHER

Ehanced recovery after surgery protocols were applied

non ERAS group

conventional method of post op care was used

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ERAS Protocol

Ehanced recovery after surgery protocols were applied

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children Hospital and Institute of Child Health, Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Adeel Ashiq

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adeel A Gujjar, M.S

Role: PRINCIPAL_INVESTIGATOR

Consultant Surgeon

Locations

The Children Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Adeel3

Identifier Type: -

Identifier Source: org_study_id