ERAS Protocol in Laparoscopic Hysterectomy

June 13, 2019 updated by: Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital

The Impact of Implementing ERAS Protocol on Healthcare Costs in Patients Undergoing Laparoscopic Hysterectomy

ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay in various kinds of surgical procedures. This study aimed to investigate whether ERAS protocol has an impact on healthcare costs in patients undergoing a laparoscopic hysterectomy. Patients scheduled for laparoscopic hysterectomy will be allocated to one of the study groups: ERAS group patients will receive ERAS protocol during the perioperative period; Conventional care groups will undergo standard abdominal hysterectomy without the implementation of ERAS protocol. The groups will be compared with respect to the length of hospital stay, rehospitalizations, and healthcare costs.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Please Enter The State Or Province
      • Istanbul, Please Enter The State Or Province, Turkey, 34005
        • Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Must be scheduled for laparoscopic hysterectomy

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) class IV
  • Development of complications during surgery
  • Body mass index > 40 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ERAS group
Patients in this group will receive ERAS protocol preoperatively, perioperatively and postoperatively.
Other: Enhanced recovery after surge(ERAS) protocol

The components of ERAS multidisciplinary pathway concerning preoperative, operative, and postoperative period are as follows:

  1. Preoperative care:

    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

  2. Perioperative care:

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

Postoperative care:

Application of midthoracic, epidural anesthesia/analgesia 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
No Intervention: Control
This group of patients will not receive ERAS care and will undergo a standard laparoscopic hysterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare costs
Time Frame: Up to one month
Hospital costs will be obtained from the accounting office of the hospital
Up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Up to one month
Length of hospital stay
Up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Aysu Akca, MD, Kanuni Sultan Suleyman Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 20, 2019

Primary Completion (Anticipated)

July 15, 2019

Study Completion (Anticipated)

July 18, 2019

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AYSUAKCA2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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