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

Primary Purpose

Urinary Incontinence, Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ERAS Protocol
Conventional care
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Insulin dependent diabetes

Sites / Locations

  • Kanuni Sultan Suleyman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ERAS group

Conventional care

Arm Description

This groups will receive ERAS protocol

This group will not receive the ERAS protocol.

Outcomes

Primary Outcome Measures

Ambulation
Time to ambulation
Hospital stay
Length of hospital stay

Secondary Outcome Measures

Full Information

First Posted
June 30, 2019
Last Updated
February 19, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04008654
Brief Title
Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse
Official Title
Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Active Comparator
Arm Description
This groups will receive ERAS protocol
Arm Title
Conventional care
Arm Type
Placebo Comparator
Arm Description
This group will not receive the ERAS protocol.
Intervention Type
Behavioral
Intervention Name(s)
ERAS Protocol
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional care
Intervention Description
This group of patients will not receive the specific ERAS protocol but will receive conventional care.
Primary Outcome Measure Information:
Title
Ambulation
Description
Time to ambulation
Time Frame
Up to 1 week
Title
Hospital stay
Description
Length of hospital stay
Time Frame
Up to 1month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse Exclusion Criteria: Insulin dependent diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin Kiyak, MD
Organizational Affiliation
Kanuni Sultan Suleyman Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Please Enter The State Or Province
ZIP/Postal Code
34005
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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