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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04174950
Other study ID # 2018-107
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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