Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients

November 20, 2019 updated by: yuxuefei, Second Affiliated Hospital, School of Medicine, Zhejiang University

Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer

To explore the effect of perioperative ERAS based nursing model on the hope level and recovery of patients with laryngeal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

200 patients who were diagnosed with laryngeal cancer and received total or partial laryngectomy were included. They were allocated into experimental and control group. Patients in experimental group were given ERAS based nursing intervention. Control group were given routine nursing intervention. Compare hope level, postoperative recovery, complication between two groups.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 0571
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were confirmed as laryngeal cancer by CT scan.
  • Patients were given total or partial laryngectomy.

Exclusion Criteria:

  • Unconscious or psychiatric patients.
  • Patients with distant metastasis or recurrence of cancer
  • Patients with coagulation dysfunction
  • Patients with severe cardiac, hepatic or renal dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Routine perioperative nursing intervention
Other: Routine nursing care
routine perioperative nursing intervention, including intensive observation of vital signs, preoperative education, postoperative communication and instruction on diet. NPO after the dinner one day before operation. Patients are instructed to NPO 3 days after surgery and patients should stay on the bed for 3 days. Urinary catheter is always kept for 48 hours or more.
Experimental: experimental group
Perioperative ERAS Based Nursing Model
Other: Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model
Establish ERAS nursing team and formulate ERAS nursing intervention. Nothing by mouth (NPO) 6 hours before operation and no water 4 hours before operation. Patients are given fluid food 24 hours after surgery. Urinary catheter is removed within 24 hours after surgery and encourage patient to mobile 24 hours after surgery. Give support to pain control and psychological support. Intensive observation of vital signs, preoperative education, postoperative communication and instruction on diet were also given to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hope level
Time Frame: the day before surgery
Herth Hope Index which have 12 items. Each item is rated from 1 to 4. Score 1 represents lowest level. Score 4 represents highest level. Total score is 48.
the day before surgery
Hope level
Time Frame: Day 10 after surgery
Herth Hope Index which have 12 items. Each item is rated from 1 to 4. Score 1 represents lowest level. Score 4 represents highest level. Total score is 48.
Day 10 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulation time
Time Frame: Day 3 after surgery
record the time of first ambulation
Day 3 after surgery
Level of Pain
Time Frame: Day 3 after surgery
Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.
Day 3 after surgery
Postoperative complication
Time Frame: Day 30 after surgery
incidence of infection, malnutrition and Viscosity of sputum
Day 30 after surgery
Length of stay
Time Frame: Day 30 after surgery
the days of hospitalization
Day 30 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Xuefei Yu, bachelor, Second Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2018

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

October 31, 2020

Study Registration Dates

First Submitted

July 12, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-107

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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