Enhanced Recovery Protocol in Urogynecologic Surgery

NCT ID: NCT04175782

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2019-12-15

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.

Conditions

Urinary Incontinence; Cystocele; Rectocele; Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enhanced recovery after surgery (ERAS) protocol

Intervention Type: PROCEDURE

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

Control

This group will receive conventional pre-and postoperative care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gulseren Yilmaz

Principal Investigator, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulseren Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Hospital

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gulseren4

Identifier Type: -

Identifier Source: org_study_id