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NCT Number: NCT07832838

ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced recovery after surgery protocol

Other

Comprehensive ERAS pathway For Arm: ERAS Group

Conventional Perioperative Care

Other

Standard routine care For Arm: Conventional Care Group

Primary outcomes

  1. 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

Secondary outcomes

  1. Length of postoperative hospital stay

    Time frame: Up to 30 days

    Length of stay measured in hours from end of surgery to discharge

  2. Postoperative pain score at 6 hours

    Time frame: At 6 hours after surgery

    Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain

  3. Postoperative pain score at 12 hours

    Time frame: At 12 hours after surgery

    Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain

  4. Postoperative pain score at 24 hours

    Time frame: At 24 hours after surgery

    Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain

  5. Time to first flatus

    Time frame: Up to 48 hours

    Time to first flatus measured in hours from end of surgery

  6. Time to first bowel movement

    Time frame: Up to 48 hours

    Time to first bowel movement measured in hours from end of surgery

  7. Time to first oral intake

    Time frame: Up to 48 hours

    Time to first oral intake measured in hours from end of surgery

  8. Time to first ambulation

    Time frame: Up to 48 hours

    Time to first ambulation measured in hours from end of surgery

  9. Total analgesic consumption

    Time frame: Within 24 hours after surgery

    Total analgesic consumption in milligrams within first 24 hours

  10. Number of participants with postoperative nausea and vomiting

    Time frame: Within 24 hours after surgery

    Number of participants who develop postoperative nausea and vomiting

  11. Number of participants with postoperative complications

    Time frame: Up to 30 days

    Number of participants with postoperative complications classified by Clavien-Dindo classification

  12. Number of participants with 30-day readmission

    Time frame: Up to 30 days

    Number of participants requiring hospital readmission within 30 days

  13. Patient satisfaction score

    Time frame: At 24 hours after surgery

    Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction

Study contacts

Contact information is provided by the study sponsor or research team.

sara M Farouk, resident

CONTACT

[email protected]

0 11 59002779

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Enhanced Recovery After Surgery (ERAS) Versus Conventional Perioperative Care Following Gynaecological Laparoscopic Surgery: A Prospective Comparative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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