ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery
Enhanced Recovery After Surgery (ERAS) Versus Conventional Perioperative Care Following Gynaecological Laparoscopic Surgery: A Prospective Comparative Study
This prospective randomized comparative study aims to compare Enhanced Recovery After Surgery (ERAS) protocol versus conventional perioperative care in women undergoing benign gynecological laparoscopic surgery. The primary outcome is quality of recovery assessed by QoR-15 score at 24 hours. Secondary outcomes include hospital stay, pain scores, bowel function, ambulation, analgesic consumption, PONV, complications, readmission, patient satisfaction and hospital cost.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic surgery is the standard approach for many benign gynecological conditions due to less tissue trauma, less pain and faster recovery. However perioperative care practices vary significantly and affect recovery.
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary evidence-based pathway designed to reduce surgical stress and accelerate recovery. ERAS includes preoperative counseling and avoidance of prolonged fasting with clear fluids up to 2 hours and carbohydrate loading, no routine mechanical bowel preparation, standardized anesthesia with multimodal opioid-sparing analgesia, goal-directed fluid therapy, active warming, postoperative nausea and vomiting prophylaxis, avoidance of drains, early oral intake, early mobilization and early urinary catheter removal.
This study will randomize 100 women aged 18 to 60 years with ASA I-III scheduled for benign gynecological laparoscopic surgery into two groups in 1 to 1 ratio using computer-generated randomization. Group A will receive ERAS pathway and Group B will receive conventional care including NPO after midnight, bowel preparation with Prepawest, conventional NSAID analgesia, delayed feeding until bowel sounds return, and catheter retention until discharge.
All patients will be followed for 30 days. Primary outcome is QoR-15 at 24 hours. Secondary outcomes include VAS pain at 6, 12 and 24 hours, time to flatus, bowel movement, oral intake, ambulation, total analgesic consumption, PONV, complications classified by Clavien-Dindo, 30-day readmission, patient satisfaction and total hospital cost.
Data will be analyzed using SPSS with t-test or Mann-Whitney for continuous variables and Chi-square or Fisher exact for categorical variables. P less than 0.05 is considered significant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: sara M Farouk, resident
- Phone Number: 0 11 59002779
- Email: sameha.18313614@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged 18-60 years
- Indicated for benign gynaecologic laparoscopic surgery
- ASA physical status I-III
- Ability to provide informed consent
Exclusion Criteria:
- Pregnancy
- Suspected gynecologic malignancy
- Conversion to laparotomy
- Severe systemic disease preventing ERAS implementation
- Inability to comply with follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ERAS Group
ERAS protocol with counseling avoidance of prolonged fasting carb loading multimodal analgesia early feeding early mobilization early catheter removal |
Comprehensive ERAS pathway For Arm: ERAS Group |
|
Active Comparator: Conventional Care Group
Conventional care with NPO after midnight bowel prep with Prepawest conventional NSAIDs delayed feeding catheter until discharge discharge by surgeon discretion |
Standard routine care For Arm: Conventional Care Group |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery-15 score at 24 hours
Time Frame: At 24 hours after surgery
|
Quality of Recovery-15 score measured by QoR-15 questionnaire from 0 to 150 higher score means better recovery |
At 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of postoperative hospital stay
Time Frame: Up to 30 days
|
Length of stay measured in hours from end of surgery to discharge |
Up to 30 days
|
|
Postoperative pain score at 6 hours
Time Frame: At 6 hours after surgery
|
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
At 6 hours after surgery
|
|
Postoperative pain score at 12 hours
Time Frame: At 12 hours after surgery
|
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
At 12 hours after surgery
|
|
Postoperative pain score at 24 hours
Time Frame: At 24 hours after surgery
|
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
At 24 hours after surgery
|
|
Time to first flatus
Time Frame: Up to 48 hours
|
Time to first flatus measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first bowel movement
Time Frame: Up to 48 hours
|
Time to first bowel movement measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first oral intake
Time Frame: Up to 48 hours
|
Time to first oral intake measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first ambulation
Time Frame: Up to 48 hours
|
Time to first ambulation measured in hours from end of surgery |
Up to 48 hours
|
|
Total analgesic consumption
Time Frame: Within 24 hours after surgery
|
Total analgesic consumption in milligrams within first 24 hours |
Within 24 hours after surgery
|
|
Number of participants with postoperative nausea and vomiting
Time Frame: Within 24 hours after surgery
|
Number of participants who develop postoperative nausea and vomiting |
Within 24 hours after surgery
|
|
Number of participants with postoperative complications
Time Frame: Up to 30 days
|
Number of participants with postoperative complications classified by Clavien-Dindo classification |
Up to 30 days
|
|
Number of participants with 30-day readmission
Time Frame: Up to 30 days
|
Number of participants requiring hospital readmission within 30 days |
Up to 30 days
|
|
Patient satisfaction score
Time Frame: At 24 hours after surgery
|
Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction |
At 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mahmoud S Mohamed, prof, obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERAS-GynLap-Assiut-28
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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