Back to resultsPerioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients
Primary Purpose
Laryngeal Cancer, Nursing
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine nursing care
Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model
Sponsored by
About this trial
This is an interventional supportive care trial for Laryngeal Cancer focused on measuring Laryngeal cancer, enhanced recovery after surgery, hope level
Eligibility Criteria
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.
Sites / Locations
- Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
Routine perioperative nursing intervention
Perioperative ERAS Based Nursing Model
Outcomes
Primary Outcome Measures
Hope level
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.
Hope level
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
Ambulation time
record the time of first ambulation
Level of Pain
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.
Postoperative complication
incidence of infection, malnutrition and Viscosity of sputum
Length of stay
the days of hospitalization
Full Information
NCT ID
NCT04174950
First Posted
July 12, 2019
Last Updated
November 20, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04174950
Brief Title
Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients
Official Title
Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Cancer, Nursing
Keywords
Laryngeal cancer, enhanced recovery after surgery, hope level
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were allocated into two groups randomly.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Routine perioperative nursing intervention
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Perioperative ERAS Based Nursing Model
Intervention Type
Other
Intervention Name(s)
Routine nursing care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hope level
Description
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.
Time Frame
the day before surgery
Title
Hope level
Description
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.
Time Frame
Day 10 after surgery
Secondary Outcome Measure Information:
Title
Ambulation time
Description
record the time of first ambulation
Time Frame
Day 3 after surgery
Title
Level of Pain
Description
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.
Time Frame
Day 3 after surgery
Title
Postoperative complication
Description
incidence of infection, malnutrition and Viscosity of sputum
Time Frame
Day 30 after surgery
Title
Length of stay
Description
the days of hospitalization
Time Frame
Day 30 after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefei Yu, bachelor
Phone
13757119590
Email
2190049@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefei Yu, bachelor
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
0571
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefei Yu, Bachelor
Phone
13757119590
Email
2190049@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients
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