Enhanced Recovery Protocol in Urogynecologic Surgery

Not Applicable

Completed

• Conditions: Urinary Incontinence; Cystocele; Rectocele; Pelvic Organ Prolapse
• Interventions: Procedure: Enhanced recovery after surgery (ERAS) protocol

• Registration Number: NCT04175782
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

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 Timeline

• Study Start: 2019-07-20
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• Age must be > 18 years
• Must be scheduled for urogynecologic surgery

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Exclusion Criteria

• Emergency surgery
• Presence of preoperative sepsis
• Presence of advanced liver or kidney disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	Enhanced recovery after surgery (ERAS) protocol	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.

Primary Outcome Measures

Name	Time	Method
Time to ambulation	Up to 1 week	Hours

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Please Enter The State Or Province, Turkey