Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients

Nursing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174950
• Other study ID #: 2018-107
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xuefei Yu, bachelor
• Phone: 13757119590
• Email: 2190049[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Cancer
• Laryngeal Neoplasms
• 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.
• 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the day before surgery
Primary	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.	Day 10 after surgery
Secondary	Ambulation time	record the time of first ambulation	Day 3 after surgery
Secondary	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.	Day 3 after surgery
Secondary	Postoperative complication	incidence of infection, malnutrition and Viscosity of sputum	Day 30 after surgery
Secondary	Length of stay	the days of hospitalization	Day 30 after surgery