Gynecologic DiseaseNCT07832838
ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery
A study testing Enhanced Recovery After Surgery Protocol and Conventional Perioperative Care in people with Gynecologic Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Enhanced Recovery After Surgery Protocol and Conventional Perioperative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-60 years
- Indicated for benign gynaecologic laparoscopic surgery
- ASA physical status I-III
- Ability to provide informed consent
Who cannot join
- Pregnancy
- Suspected gynecologic malignancy
- Conversion to laparotomy
- Severe systemic disease preventing ERAS implementation
- Inability to comply with follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Disease
- Being tested
- Enhanced Recovery After Surgery Protocol, Conventional Perioperative Care
- Keywords
- ERAS, Enhanced Recovery After Surgery, Gynecologic Laparoscopic Surgery, QoR-15, Perioperative Care, Quality of Recovery
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery ProtocolOther
Comprehensive ERAS pathway For Arm: ERAS Group
Conventional Perioperative CareOther
Standard routine care For Arm: Conventional Care Group
| Study group | Role | What they receive |
|---|---|---|
| ERAS Group | Experimental | ERAS protocol with counseling avoidance of prolonged fasting carb loading multimodal analgesia early feeding early mobilization early catheter removal Receives: Other: Enhanced Recovery After Surgery Protocol |
| Conventional Care Group | Active comparator | Conventional care with NPO after midnight bowel prep with Prepawest conventional NSAIDs delayed feeding catheter until discharge discharge by surgeon discretion Receives: Other: Conventional Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 24 hours after surgery
Secondary outcomes (13)
Length of postoperative hospital stay
Length of stay measured in hours from end of surgery to discharge
Measured: 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
Measured: 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
Measured: 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
Measured: At 24 hours after surgery
Time to first flatus
Time to first flatus measured in hours from end of surgery
Measured: Up to 48 hours
Time to first bowel movement
Time to first bowel movement measured in hours from end of surgery
Measured: Up to 48 hours
Time to first oral intake
Time to first oral intake measured in hours from end of surgery
Measured: Up to 48 hours
Time to first ambulation
Time to first ambulation measured in hours from end of surgery
Measured: Up to 48 hours
Total analgesic consumption
Total analgesic consumption in milligrams within first 24 hours
Measured: Within 24 hours after surgery
Number of participants with postoperative nausea and vomiting
Number of participants who develop postoperative nausea and vomiting
Measured: Within 24 hours after surgery
Number of participants with postoperative complications
Number of participants with postoperative complications classified by Clavien-Dindo classification
Measured: Up to 30 days
Number of participants with 30-day readmission
Number of participants requiring hospital readmission within 30 days
Measured: Up to 30 days
Patient satisfaction score
Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Farouk, Assiut University
- Investigators
- Mahmoud S Mohamed, prof, Study chair, obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832838
- Sponsor's protocol ID
- ERAS-GynLap-Assiut-28
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery (ERAS) Versus Conventional Perioperative Care Following Gynaecological Laparoscopic Surgery: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07832838
- Acronym / sponsor ID
- ERAS-GynLap-Assiut-28
- Conditions
- Gynecologic Disease
- Keywords
- ERAS, Enhanced Recovery After Surgery, Gynecologic Laparoscopic Surgery, QoR-15, Perioperative Care, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS Group | Experimental | Other: Enhanced Recovery After Surgery ProtocolERAS protocol with counseling avoidance of prolonged fasting carb loading multimodal analgesia early feeding early mobilization early catheter removal |
| Conventional Care Group | Active comparator | Other: Conventional Perioperative CareConventional care with NPO after midnight bowel prep with Prepawest conventional NSAIDs delayed feeding catheter until discharge discharge by surgeon discretion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-60 years
- Indicated for benign gynaecologic laparoscopic surgery
- ASA physical status I-III
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Suspected gynecologic malignancy
- Conversion to laparotomy
- Severe systemic disease preventing ERAS implementation
- Inability to comply with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After Surgery ProtocolComprehensive ERAS pathway For Arm: ERAS Group | Other | ERAS Group |
| Conventional Perioperative CareStandard routine care For Arm: Conventional Care Group | Other | Conventional Care Group |
Primary outcome
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
13 secondary outcomes
Length of postoperative hospital stay
Time frame: Up to 30 days
Postoperative pain score at 6 hours
Time frame: At 6 hours after surgery
Postoperative pain score at 12 hours
Time frame: At 12 hours after surgery
Postoperative pain score at 24 hours
Time frame: At 24 hours after surgery
Time to first flatus
Time frame: Up to 48 hours
Time to first bowel movement
Time frame: Up to 48 hours
Time to first oral intake
Time frame: Up to 48 hours
Time to first ambulation
Time frame: Up to 48 hours
Total analgesic consumption
Time frame: Within 24 hours after surgery
Number of participants with postoperative nausea and vomiting
Time frame: Within 24 hours after surgery
Number of participants with postoperative complications
Time frame: Up to 30 days
Number of participants with 30-day readmission
Time frame: Up to 30 days
Patient satisfaction score
Time frame: At 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Gynecologic Disease
RecruitingObservational study
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
Gynecologic Cancer, Radiotherapy Side Effect
RecruitingObservational study
Ultrasound Detection of Body Composition in Critical Care
Muscle Loss, Extracellular Fluid Alteration
Recruiting
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Enhanced Recovery After Surgery, Gynecologic Disease
Active, not recruitingPhase 1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Advanced Solid Tumors, Breast Cancer
RecruitingObservational study
GYN-AIDE: Gynecologic Oncology Navigation Through AI-Driven Education
Gynecologic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud S Mohamed, prof study chair
obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery Protocol and Conventional Perioperative Care in people with Gynecologic Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sara M Farouk, resident (0 11 59002779, sameha.18313614@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 score at 24 hours (time frame: At 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.