Enhanced Recovery After SurgeryNCT05528484
Self-reported Outcomes of Patients in ERAS Nursing
A study testing ERAS nursing and non eras nursing in people with Enhanced Recovery After Surgery, run by The Second Hospital of Shandong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- ERAS nursing and non eras nursing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18years,Minimally invasive elective surgery,cooperate
Who cannot join
- Pneumonectomy was performed and converted to open surgery
- Surgery intensive care, unable to cooperate (language
- Speech disorders, psychopathology)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongju Wang contact
China1 site, 1 recruiting
- Recruiting
The second hospital of shandong university
Jinan, Shandong, 250033
Ying Liu, 17660081909, liuxia5945@126.com
About this study
Official title: Effect of ERAS Nursing on Self-reported Outcomes of Patients Undergoing Minimally Invasive Lung Cancer Surgery
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
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- ERAS nursing, non eras nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS nursingProcedure or surgery
Patients were given education before surgery, fluid and anesthetic drug management during surgery, early ambulation, fluid management and early feeding after surgery, etc
non eras nursingProcedure or surgery
Patients were under the routine management without eras protocol
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | the patients accepting eras nursing protocol ; Receives: Procedure: ERAS nursing |
| non-eras group | Active comparator | the patients not accepting eras nursing protocol ; Receives: Procedure: non eras nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Outcomes of Patients(PRO)
Use MD Anderson Symptom Checklist - Lung Cancer Symptom to measure severity and functional status
Measured: 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)
length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM)
Measured: From admission to one month after the patient's discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Oct 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528484
- Sponsor's protocol ID
- ERAS (PRO)-based study
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ERAS Nursing on Self-reported Outcomes of Patients Undergoing Minimally Invasive Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT05528484
- Acronym / sponsor ID
- ERAS (PRO)-based study
- Conditions
- Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Procedure: ERAS nursingthe patients accepting eras nursing protocol ; |
| non-eras group | Active comparator | Procedure: non eras nursingthe patients not accepting eras nursing protocol ; |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18years,Minimally invasive elective surgery,cooperate
Key exclusion criteria (3 listed)
- Pneumonectomy was performed and converted to open surgery
- Surgery intensive care, unable to cooperate (language
- Speech disorders, psychopathology)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS nursingPatients were given education before surgery, fluid and anesthetic drug management during surgery, early ambulation, fluid management and early feeding after surgery, etc | Procedure or surgery | ERAS group |
| non eras nursingPatients were under the routine management without eras protocol | Procedure or surgery | non-eras group |
Primary outcome
Self-reported Outcomes of Patients(PRO)
Time frame: at baseline, daily after surgery, and weekly up to 4 after discharge weekly.
Use MD Anderson Symptom Checklist - Lung Cancer Symptom to measure severity and functional status
1 secondary outcome
length of stay (LOS), postoperative cardiopulmonary complications (CPC) and readmission rate (READM)
Time frame: From admission to one month after the patient's discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongju Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS nursing and non eras nursing in people with Enhanced Recovery After Surgery, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ying liu (17660081909, liuxia5945@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Outcomes of Patients(PRO) (time frame: at baseline, daily after surgery, and weekly up to 4 after discharge weekly.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.