Laryngeal CancerNCT04174950
Perioperative ERAS Based Nursing Intervention for Laryngeal Cancer Patients
A study testing Routine nursing care and Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model in people with Laryngeal Cancer and Nursing, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To explore the effect of perioperative ERAS based nursing model on the hope level and recovery of patients with laryngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laryngeal Cancer, Nursing
- What is being tested?
- Routine nursing care and Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were confirmed as laryngeal cancer by CT scan.
- Patients were given total or partial laryngectomy.
Who cannot join
- Unconscious or psychiatric patients.
- Patients with distant metastasis or recurrence of cancer
- Patients with coagulation dysfunction
- Patients with severe cardiac, hepatic or renal dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 0571
Xuefei Yu, Bachelor, 13757119590, 2190049@zju.edu.cn
About this study
Official title: Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer
To explore the effect of perioperative ERAS based nursing model on the hope level and recovery of patients with laryngeal cancer.
Read the detailed 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.
- Conditions
- Laryngeal Cancer, Nursing
- Being tested
- Routine nursing care, Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model
- Keywords
- Laryngeal cancer, enhanced recovery after surgery, hope level
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Routine perioperative nursing intervention Receives: Other: Routine nursing care |
| experimental group | Experimental | Perioperative ERAS Based Nursing Model Receives: Other: Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 10 after surgery
Secondary outcomes (4)
Ambulation time
record the time of first ambulation
Measured: Day 3 after surgery
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.
Measured: Day 3 after surgery
Postoperative complication
incidence of infection, malnutrition and Viscosity of sputum
Measured: Day 30 after surgery
Length of stay
the days of hospitalization
Measured: Day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start14 Sep 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- Participants were allocated into two groups randomly.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yuxuefei, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Xuefei Yu, bachelor, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174950
- Sponsor's protocol ID
- 2018-107
- Status last verified
- Nov 2019
- First submitted
- 12 Jul 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative ERAS Based Nursing Intervention on Hope Level of Patients With Laryngeal Cancer
- ClinicalTrials.gov ID
- NCT04174950
- Acronym / sponsor ID
- 2018-107
- Conditions
- Laryngeal Cancer, Nursing
- Keywords
- Laryngeal cancer, enhanced recovery after surgery, hope level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 22 Nov 2019 (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.
To explore the effect of perioperative ERAS based nursing model on the hope level and recovery of patients with laryngeal cancer.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were allocated into two groups randomly.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Routine nursing careRoutine perioperative nursing intervention |
| experimental group | Experimental | Other: Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing ModelPerioperative ERAS Based Nursing Model |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were confirmed as laryngeal cancer by CT scan.
- Patients were given total or partial laryngectomy.
Key exclusion criteria (4 listed)
- Unconscious or psychiatric patients.
- Patients with distant metastasis or recurrence of cancer
- Patients with coagulation dysfunction
- Patients with severe cardiac, hepatic or renal dysfunction.
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 |
|---|---|---|
| Routine nursing careroutine 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. | Other | control group |
| Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing ModelEstablish 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. | Other | experimental group |
Primary outcome
Hope level
Time frame: the day before surgery
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.
Hope level
Time frame: Day 10 after surgery
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.
4 secondary outcomes
Ambulation time
Time frame: Day 3 after surgery
Level of Pain
Time frame: Day 3 after surgery
Postoperative complication
Time frame: Day 30 after surgery
Length of stay
Time frame: Day 30 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xuefei Yu, bachelor principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine nursing care and Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model in people with Laryngeal Cancer and Nursing, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuefei Yu, bachelor (13757119590, 2190049@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hope level (time frame: the day before surgery). The study lists 2 primary outcomes in all. 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 22 Nov 2019.