NCT05528484

Brief Summary

We aimed to evaluate the effect of ERAS nursing program on self-reported outcomes of patients undergoing minimally invasive lung cancer surgery, and compared the differences in length of hospital stay, complications, and readmission rate between ERAS and non-ERAS nursing programs

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress84%
Oct 2019Aug 2027

Study Start

First participant enrolled

October 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Expected
Last Updated

November 16, 2022

Status Verified

August 1, 2022

Enrollment Period

3.7 years

First QC Date

September 1, 2022

Last Update Submit

November 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported Outcomes of Patients(PRO)

    Use MD Anderson Symptom Checklist - Lung Cancer Symptom to measure severity and functional status

    at baseline, daily after surgery, and weekly up to 4 after discharge weekly.

Secondary Outcomes (1)

  • length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM)

    From admission to one month after the patient's discharge

Study Arms (2)

ERAS group

EXPERIMENTAL

the patients accepting eras nursing protocol ;

Procedure: ERAS nursing

non-eras group

ACTIVE COMPARATOR

the patients not accepting eras nursing protocol ;

Procedure: non eras nursing

Interventions

ERAS nursingPROCEDURE

Patients were given education before surgery, fluid and anesthetic drug management during surgery, early ambulation, fluid management and early feeding after surgery, etc

ERAS group

Patients were under the routine management without eras protocol

non-eras group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18years,Minimally invasive elective surgery,cooperate

You may not qualify if:

  • Pneumonectomy was performed and converted to open surgery
  • Surgery intensive care, unable to cooperate (language
  • Speech disorders, psychopathology)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second hospital of shandong university

Jinan, Shandong, 250033, China

RECRUITING

Central Study Contacts

Hongju Wang

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

October 1, 2019

Primary Completion

June 1, 2023

Study Completion (Estimated)

August 31, 2027

Last Updated

November 16, 2022

Record last verified: 2022-08

Locations