ERAS Protocol in Laparoscopic Hysterectomy

NCT ID: NCT03986450

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-20

Study Completion Date

2019-07-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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ERAS group

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

Group Type ACTIVE_COMPARATOR

Enhanced recovery after surge(ERAS) protocol

Intervention Type 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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aysu Akca

Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysu Akca, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Hospital

Locations

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

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

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Aysu Akca, MD

Role: CONTACT

+902124041500

Other Identifiers

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AYSUAKCA2

Identifier Type: -

Identifier Source: org_study_id

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