Gynecologic Disease
Conditions
Keywords
ERAS, Enhanced Recovery After Surgery, Gynecologic Laparoscopic Surgery, QoR-15, Perioperative Care, Quality of Recovery
Brief summary
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.
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.
Interventions
Comprehensive ERAS pathway For Arm: ERAS Group
Standard routine care For Arm: Conventional Care Group
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 score at 24 hours | At 24 hours after surgery | Quality of Recovery-15 score measured by QoR-15 questionnaire from 0 to 150 higher score means better recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative hospital stay | Up to 30 days | Length of stay measured in hours from end of surgery to discharge |
| Postoperative pain score at 6 hours | At 6 hours after surgery | Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
| Postoperative pain score at 12 hours | At 12 hours after surgery | Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
| Postoperative pain score at 24 hours | At 24 hours after surgery | Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
| Time to first flatus | Up to 48 hours | Time to first flatus measured in hours from end of surgery |
| Time to first bowel movement | Up to 48 hours | Time to first bowel movement measured in hours from end of surgery |
| Time to first oral intake | Up to 48 hours | Time to first oral intake measured in hours from end of surgery |
| Time to first ambulation | Up to 48 hours | Time to first ambulation measured in hours from end of surgery |
| Total analgesic consumption | Within 24 hours after surgery | Total analgesic consumption in milligrams within first 24 hours |
| Number of participants with postoperative nausea and vomiting | Within 24 hours after surgery | Number of participants who develop postoperative nausea and vomiting |
| Number of participants with postoperative complications | Up to 30 days | Number of participants with postoperative complications classified by Clavien-Dindo classification |
| Number of participants with 30-day readmission | Up to 30 days | Number of participants requiring hospital readmission within 30 days |
| Patient satisfaction score | At 24 hours after surgery | Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction |
Contacts
CONTACTsara M Farouk, resident
STUDY_CHAIRMahmoud S Mohamed, prof
obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt
Outcome results
None listed