NCT04174950

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

July 12, 2019

Last Update Submit

November 20, 2019

Conditions

Laryngeal CancerNursing

Keywords

Laryngeal cancerenhanced recovery after surgeryhope level

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Ambulation time

    Day 3 after surgery

  • Level of Pain

    Day 3 after surgery

  • Postoperative complication

    Day 30 after surgery

  • Length of stay

    Day 30 after surgery

Study Arms (2)

control group

ACTIVE COMPARATOR

Routine perioperative nursing intervention

Other: Routine nursing care

experimental group

EXPERIMENTAL

Perioperative ERAS Based Nursing Model

Other: Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model

Interventions

Routine nursing careOTHER

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.

control group
Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing ModelOTHER

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.

experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 0571, China

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Study Officials

  • Xuefei Yu, bachelor

    Second Affiliated Hospital of Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefei Yu, bachelor

CONTACT

137571195902190049@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were allocated into two groups randomly.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Nurse

Study Record Dates

First Submitted

July 12, 2019

First Posted

November 22, 2019

Study Start

September 14, 2018

Primary Completion

June 30, 2020

Study Completion

October 31, 2020

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)