Enhanced Recovery After Cholecystectomy

NCT06339437 | Completed

• 1 other identifier: Adeel3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiases

Keywords

ERAS; GALL STONE DISEASE; LAPAROSCOPIC CHOLECYSTECTOMY

Outcome Measures

Primary Outcomes (2)

• PONV

  post op nausea and vomiting measured

  24 hours

• Visual Analogue Scale score

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

  24 hours

Study Arms (2)

ERAS group

EXPERIMENTAL

ERAS protocol applied in this group

Other: ERAS Protocol

non ERAS group

NO INTERVENTION

conventional method of post op care was used

Interventions

ERAS Protocol OTHER

Ehanced recovery after surgery protocols were applied

ERAS group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages between 20 to 60 years
• All genders included
• ASA class I and II
• Undergoing elective laparoscopic cholecystectomy for uncomplicated symptomatic gallstone disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Adeel A Gujjar, M.S

  Consultant Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomeassessor was not told about group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: ERAS protocols applied

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 1, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)