An interventional study of Enhanced Recovery After Surgery Protocol and Conventional Perioperative Care in Gynecologic Disease, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Assiut University · Not applicable, Interventional, and Supportive care
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.
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.
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.
Browse Genital Diseases, Female studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ERAS protocol with counseling avoidance of prolonged fasting carb loading multimodal analgesia early feeding early mobilization early catheter removal
Other: Enhanced Recovery After Surgery Protocol
Conventional care with NPO after midnight bowel prep with Prepawest conventional NSAIDs delayed feeding catheter until discharge discharge by surgeon discretion
Other: Conventional Perioperative Care
Comprehensive ERAS pathway For Arm: ERAS Group
Standard routine care For Arm: Conventional Care Group
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 surgery
Length of postoperative hospital stay
Length of stay measured in hours from end of surgery to discharge
Time frame: Up to 30 days
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 surgery
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 surgery
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 surgery
Time to first flatus
Time to first flatus measured in hours from end of surgery
Time frame: Up to 48 hours
Time to first bowel movement
Time to first bowel movement measured in hours from end of surgery
Time frame: Up to 48 hours
Time to first oral intake
Time to first oral intake measured in hours from end of surgery
Time frame: Up to 48 hours
Time to first ambulation
Time to first ambulation measured in hours from end of surgery
Time frame: Up to 48 hours
Total analgesic consumption
Total analgesic consumption in milligrams within first 24 hours
Time frame: Within 24 hours after surgery
Number of participants with postoperative nausea and vomiting
Number of participants who develop postoperative nausea and vomiting
Time frame: Within 24 hours after surgery
Number of participants with postoperative complications
Number of participants with postoperative complications classified by Clavien-Dindo classification
Time frame: Up to 30 days
Number of participants with 30-day readmission
Number of participants requiring hospital readmission within 30 days
Time frame: Up to 30 days
Patient satisfaction score
Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction
Time frame: At 24 hours after surgery
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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