Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04174950
Collaborator
(none)
200
1
2
25.6
7.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Routine nursing care
  • Other: Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants were allocated into two groups randomly.Participants were allocated into two groups randomly.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer
Actual Study Start Date :
Sep 14, 2018
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Oct 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hope level [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.

  2. Hope level [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.

Secondary Outcome Measures

  1. Ambulation time [Day 3 after surgery]

    record the time of first ambulation

  2. Level of Pain [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.

  3. Postoperative complication [Day 30 after surgery]

    incidence of infection, malnutrition and Viscosity of sputum

  4. Length of stay [Day 30 after surgery]

    the days of hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 0571

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
yuxuefei, Head Nurse, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04174950
Other Study ID Numbers:
  • 2018-107
First Posted:
Nov 22, 2019
Last Update Posted:
Nov 22, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by yuxuefei, Head Nurse, Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2019