ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery
ConditionGynecologic Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18-60 years
Indicated for benign gynaecologic laparoscopic surgery
ASA physical status I-III
Ability to provide informed consent
Disqualifiers
Pregnancy
Suspected gynecologic malignancy
Conversion to laparotomy
Severe systemic disease preventing ERAS implementation
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Recovery After Surgery Protocol
Other interventionComprehensive ERAS pathway For Arm: ERAS Group
Conventional Perioperative Care
Other interventionStandard routine care For Arm: Conventional Care Group
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ERAS GroupExperimental treatment 1 intervention
Group B: Conventional Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Recovery-15 score at 24 hours
Quality of Recovery-15 score measured by QoR-15 questionnaire from 0 to 150 higher score means better recovery
Time frame
At 24 hours after surgerySecondary outcomes
1
Length of postoperative hospital stay
Length of stay measured in hours from end of surgery to discharge
Time frame
Up to 30 days2
Postoperative pain score at 6 hours
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain
Time frame
At 6 hours after surgery3
Postoperative pain score at 12 hours
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain
Time frame
At 12 hours after surgery4
Postoperative pain score at 24 hours
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain
Time frame
At 24 hours after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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