- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07564063
Enhanced Recovery After Surgery in Hysterectomy Patients (ERAS)
Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols in Hysterectomy Patients. A Prospective,Randomized Controlled Clinical Trial.
Study Overview
Status
Intervention / Treatment
Detailed Description
Enhanced Recovery After Surgery (ERAS) protocols are structured, multidisciplinary perioperative care pathways developed to optimize surgical outcomes by minimizing physiological stress and promoting early recovery. These protocols include preoperative counseling, shortened fasting with carbohydrate loading, opioid-sparing anesthesia, early feeding, and early mobilization.
Hysterectomy remains one of the most common gynecological procedures worldwide and is often associated with prolonged hospital stay and postoperative morbidity, particularly in resource-limited settings. While international evidence supports the benefits of ERAS in improving outcomes such as reduced length of hospital stay, improved pain control, and decreased complications, there is a need for locally generated data to validate its effectiveness in Egyptian tertiary healthcare settings.
This study will be conducted at Kasr Al-Ainy Hospital, Cairo University, and will include women undergoing elective hysterectomy for benign or early-stage malignant gynecological conditions. Participants will be randomly assigned to either the ERAS group or the conventional care group. Outcomes will be assessed during hospitalization and up to 30 days postoperatively.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ehab H Sorour, MD
- Phone Number: +201112496821
- Email: dr.ehabsorour@gmail.com
Study Contact Backup
- Name: Mohamed E El Mahy, MD
- Phone Number: +201111831716
- Email: mohammed.elmahy@kasralainy.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Medicine-Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18-70 years.
- Undergoing elective total hysterectomy for benign or early stage malignant gynacological conditions .
- ASA ( American Society of Anesthesiologists ) physical status I-II.
- Able to provide informed consent.
Exclusion Criteria:
- Emergency hysterectomy
- Advanced malignant requiring extensive debulking
- Known bowel disease or previous bowel surgery ( crohn's disease , bowel obstruction )
- Significant cognitive impairment or psychiatric illness
- Inability to follow ERAS protocol (e.g., cognitive impairment)
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ERAS group
Preoperative counseling Reduced fasting and carbohydrate loading Standardized anesthesia with reduced opioid use Early oral feeding Early mobilization Multimodal analgesia IV dextrose infusion (5%) 500 ml once or apple juice( 200-400 mL) 2-3 hours before anesthesia
|
IV dextrose infusion (5%) 500 ml once ,2-3 hours before anesthesia
Reduced fasting Early oral feeding Early mobilization
|
|
No Intervention: Conventional care
Overnight fasting Delayed postoperative feeding Opioid-based analgesia Delayed mobilization Routine prolonged use of drains/catheters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of hospital stay (LOS)
Time Frame: From day of surgery up to 7 postoperative days
|
Time from completion of surgery to hospital discharge readiness, measured in days.
|
From day of surgery up to 7 postoperative days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain score
Time Frame: At 12 and 24 hours postoperatively
|
Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
|
At 12 and 24 hours postoperatively
|
|
time to first bowel movement
Time Frame: Up to 5 postoperative days
|
the interval (in hours) from completion of surgery to the first documented passage of stool."
|
Up to 5 postoperative days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ehab H Sorour, MD, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-729-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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