ERAS Protocol in Laparoscopic Hysterectomy

NCT03986450 | Unknown

• 1 other identifier: AYSUAKCA2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Enhanced recovery after surgery; Laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• Healthcare costs

  Hospital costs will be obtained from the accounting office of the hospital

  Up to one month

Secondary Outcomes (1)

• Length of stay

  Up to one month

Study Arms (2)

ERAS group

ACTIVE COMPARATOR

Patients in this group will receive ERAS protocol preoperatively, perioperatively and postoperatively.

Other: Enhanced recovery after surge(ERAS) protocol

Control

NO INTERVENTION

This group of patients will not receive ERAS care and will undergo a standard laparoscopic hysterectomy.

Interventions

Enhanced recovery after surge(ERAS) protocol OTHER

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

ERAS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be scheduled for laparoscopic hysterectomy

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Aysu Akca, MD

  Kanuni Sultan Suleyman Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysu Akca, MD

CONTACT

+902124041500; aysuakca4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 14, 2019
• Study Start: June 20, 2019
• Primary Completion: July 15, 2019
• Study Completion: July 18, 2019
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)