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ERAS Protocol in Laparoscopic Hysterectomy

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ClinicalTrials.gov Identifier: NCT03986450
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgery Other: Enhanced recovery after surge(ERAS) protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Impact of Implementing ERAS Protocol on Healthcare Costs in Patients Undergoing Laparoscopic Hysterectomy
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Healthcare costs [ Time Frame: Up to one month ]
    Hospital costs will be obtained from the accounting office of the hospital


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Up to one month ]
    Length of hospital stay



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986450


Contacts
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Contact: Aysu Akca, MD +902124041500 aysuakca4@gmail.com

Locations
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Turkey
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
Istanbul, Please Enter The State Or Province, Turkey, 34005
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Principal Investigator: Aysu Akca, MD Kanuni Sultan Suleyman Hospital

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Responsible Party: Aysu Akca, Principal Investigator, M.D., Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03986450     History of Changes
Other Study ID Numbers: AYSUAKCA2
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital:
Enhanced recovery after surgery
Laparoscopic hysterectomy