Enhanced Recovery Protocol in Urogynecologic Surgery

Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

Enhanced recovery after surgery (ERAS) has been shown to improve postoperative outcomes in a variety of surgical conditions. However, data regarding its role in urogynecologic surgery is limited. This study aimed to investigate the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Enhanced recovery after surgery (ERAS) protocol

Detailed Description

Enhanced recovery after surgery (ERAS) or in other words "fast-track" protocol roughly purposes to improve patient satisfaction, reduce complications and shorten the hospital stay. Chronic diseases, nutrition, and any volume depletion are corrected prior to surgery and less invasive surgical techniques are utilized to this end The impact of ERAS protocols in decreasing length of stay (LOS), reducing postoperative pain, improving early ambulation and decreasing the rate of potentially serious medical complications have been studied in patients undergoing colorectal, urologic, gastric and pancreatic surgery previously. However, data regarding the role of ERAS protocol in improving postoperative outcomes and postoperative compliance in patients undergoing urogynecological surgery is limited.

The present study purposes to clarify the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

Study Design

Study Type:
Actual Enrollment :
125 participants
Intervention Model:
Parallel Assignment
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Official Title:
Comparison of Enhanced Recovery Protocol With Conventional Care in Patients Undergoing Urogynecologic Surgery
Actual Study Start Date :
Jul 20, 2019
Actual Primary Completion Date :
Dec 10, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: ERAS group

A standardized ERAS protocol is applied to the ERAS group based on the latest guidelines. Smoking and alcohol consumption is stopped 4 weeks before the surgery. Preoperative anemia is corrected with intravenous iron supplementation. Prolonged fasting, bowel preparation, and premedication are avoided in this group. Clear fluids are allowed up to 2 h and solids rich in carbohydrate up to 6 h hours prior to induction of anesthesia. Warmed up intravenous fluids are administered to maintain normothermia intraoperatively. This group of subjects receives general anesthesia. Volume and salt overload and drain usage are avoided to the utmost. Intravenous paracetamol is administered for postoperative analgesia before the completion of the surgical procedure. Nasogastric tube placement is avoided and catheters are removed as soon as possible. Nonopioid oral analgesics and NSAIDs are utilized for postoperative pain medication.

Procedure: Enhanced recovery after surgery (ERAS) protocol
Preoperative: Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis Avoiding premedication Intraoperative: Use of short-acting anesthetic agents Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids) Postoperative: Refraining from the use of nasogastric tube Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization Adherence to the protocol, and auditing results

No Intervention: Control

This group will receive conventional pre-and postoperative care.

Outcome Measures

Primary Outcome Measures

  1. Time to ambulation [Up to 1 week]


Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Age must be > 18 years

  • Must be scheduled for urogynecologic surgery

Exclusion Criteria:
  • Emergency surgery

  • Presence of preoperative sepsis

  • Presence of advanced liver or kidney disease

Contacts and Locations


Site City State Country Postal Code
1 Kanuni Sultan Suleyman Training and Research Hospital Istanbul Please Enter The State Or Province Turkey 34005

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital


  • Principal Investigator: Gulseren Yilmaz, MD, Kanuni Sultan Suleyman Hospital

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Gulseren Yilmaz, Principal Investigator, M.D., Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • Gulseren4
First Posted:
Nov 25, 2019
Last Update Posted:
Feb 20, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 20, 2020