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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03986450
Other study ID # AYSUAKCA2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2019
Est. completion date July 18, 2019

Study information

Verified date June 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact Aysu Akca, MD
Phone +902124041500
Email aysuakca4@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 18, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman 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 Healthcare costs Hospital costs will be obtained from the accounting office of the hospital Up to one month
Secondary Length of stay Length of hospital stay Up to one month
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