Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse

Urinary Incontinence Clinical Trial

Official title:

Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008654
• Other study ID #: Huseyin2
• Status: Completed
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: February 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Description:

ERAS protocols containing several preoperative, intraoperative and postoperative measures have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay in patients undergoing surgery. However, data concerning the role of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 20, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse

Exclusion Criteria:

• Insulin dependent diabetes

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Intervention

Behavioral:
• ERAS Protocol
Preoperative measures: 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 measures: Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids) Postoperative: Application of midthoracic, epidural anesthesia/analgesia Refraining from 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
• Conventional care
This group of patients will not receive the specific ERAS protocol but will receive conventional care.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Please Enter The State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulation	Time to ambulation	Up to 1 week
Primary	Hospital stay	Length of hospital stay	Up to 1month