ERAS Protocol in Laparoscopic Hysterectomy

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: Surgery
• Intervention / Treatment: Other: Enhanced recovery after surge(ERAS) protocol

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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: 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; 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	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	Length of hospital stay	Up to one month

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Aysu Akca, MD, Kanuni Sultan Suleyman Hospital

Study record dates

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: Enhanced recovery after surgery; Laparoscopic hysterectomy
• 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