Enhanced recovery after surgery protocol
OtherComprehensive ERAS pathway For Arm: ERAS Group
NCT Number: NCT07832838
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.
Trial opening soon.
Get Notified18 year–60 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comprehensive ERAS pathway For Arm: ERAS Group
Standard routine care For Arm: Conventional Care Group
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
Time frame: Up to 30 days
Length of stay measured in hours from end of surgery to discharge
Time frame: At 6 hours after surgery
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain
Time frame: At 12 hours after surgery
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain
Time frame: At 24 hours after surgery
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain
Time frame: Up to 48 hours
Time to first flatus measured in hours from end of surgery
Time frame: Up to 48 hours
Time to first bowel movement measured in hours from end of surgery
Time frame: Up to 48 hours
Time to first oral intake measured in hours from end of surgery
Time frame: Up to 48 hours
Time to first ambulation measured in hours from end of surgery
Time frame: Within 24 hours after surgery
Total analgesic consumption in milligrams within first 24 hours
Time frame: Within 24 hours after surgery
Number of participants who develop postoperative nausea and vomiting
Time frame: Up to 30 days
Number of participants with postoperative complications classified by Clavien-Dindo classification
Time frame: Up to 30 days
Number of participants requiring hospital readmission within 30 days
Time frame: At 24 hours after surgery
Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Enhanced Recovery After Surgery (ERAS) Versus Conventional Perioperative Care Following Gynaecological Laparoscopic Surgery: A Prospective Comparative Study
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