Pituitary TumorNCT03933241
Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection
A study testing nasal irrigation in people with Pituitary Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Transsphenoidal pituitary tumor resection is currently recognized as an effective and safe surgical method,nowadays it is widely used in clinical practice . However ,Because of the endoscopic damage to the nasal mucosa during surgery and the old blood clots in the nasal cavity , after surgery the patient had nasal… Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Pituitary Tumor
- What is being tested?
- nasal irrigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Jul 2021
- 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 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients after transsphenoidal pituitary tumor resection
- Patients who can cooperate with nasal irrigation, scoring and informed consent
Who cannot join
- Patients with incomplete clinical data
- Patients with cerebrospinal fluid rhinorrhea during and after surgery (patients with cerebrospinal fluid leakage under intraoperative endoscopic observation and cerebrospinal fluid leakage when postoperative posture changes)
- patients with sphenoid sinusitis before transsphenoidal pituitary tumor resection
- Patients who cannot cooperate with the investigation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Wang Wei, Bachelor, 15888841161, 2191043@zju.edu.cn
About this study
Official title: The Application of Saline Nasal Irrigation in Patients After Transsphenoidal Pituitary Tumor Resection
Transsphenoidal pituitary tumor resection is currently recognized as an effective and safe surgical method,nowadays it is widely used in clinical practice . However ,Because of the endoscopic damage to the nasal mucosa during surgery and the old blood clots in the nasal cavity , after surgery the patient had nasal symptoms such as nasal congestion and nasal flow for a long time, which disturbed the patient's rest and sleep, affect their quality of life, some patients can develop to chronic sinus inflammation that is sphenoid sinusitis. Nasal irrigation is now widely used in the treatment of sinusitis and sphenoid sinusitis with good result. In this study, nasal irrigation was applied in the nursing process of patients after transsphenoidal pituitary tumor resection, and we want to establish the nursing management process of nasal irrigation after transsphenoidal pituitary tumor resection and use the visual analogue scale (VAS) to evaluate the nasal symptoms of patients after postoperative nasal irrigation. Use The Chinese version of the commonly used nasosinusitis scale (SNOT -20) to evaluate postoperative quality of life of patients from the four dimensions of rhino-related symptoms, vitality, social function and emotional function, and to evaluate the incidence of sphenoid sinusitis by combining imaging examination. It is expected to improve the comfort of postoperative nasal symptoms and postoperative quality of life, prevent and reduce the incidence of postoperative sphenoid sinusitis, and improve the satisfaction of patients.
Read the detailed description
Eligible patients who were willing to participate in transsphenoidal pituitary tumor resection after informed consent were selected as the study subjects,Randomly divided into experimental group and control group. The experimental group apply the routine postoperative nursing process of transsphenoidal pituitary tumor plus nasal irrigation nursing process, the control group apply the routine postoperative nursing process of transsphenoidal pituitary tumor .After the removal of nasal gauze,we use visual analogue scale (VAS) to score and observe the clinical symptoms of nasal cavity in both groups. The patients were asked to mark out the score that could represent the severity of their symptoms for evaluation. The nurses filled in the form, and the nasal comfort was re-evaluated through face-to-face talks and telephone follow-up at two days ,1 week, 4 weeks and 12 weeks after the removal of the gauze.we will apply nasosinusitis scale (SNOT -20) to measure the quality of life of the patients in the two groups at the first day, 1 week, 4 weeks and 12 weeks after the removal of nasal strips .After 12 weeks of discharge, two groups of patients were hospitalized for reexamination with pituitary MRI or CT,to determine the incidence of postoperative sphenoid sinusitis.Patients were followed up and interviewed by telephone one week, four weeks and 12 weeks after discharge, were evaluate the incidence of complications such as nasal bleeding, cerebrospinal fluid leakage and intracranial infection.
- Conditions
- Pituitary Tumor
- Being tested
- nasal irrigation
- Keywords
- nasal irrigation
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal irrigationBehavioural
nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | nasal irrigation after transsphenoidal surgery for pituitary tumor Receives: Behavioral: nasal irrigation |
| matched group | No intervention | without nasal irrigation after transsphenoidal surgery for pituitary tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal symptoms of patients
Use the visual analogue scale (VAS) to evaluate the nasal symptoms of patients after postoperative nasal irrigation. Evaluation of symptoms including nasal congestion, nasal secretions or posterior rhinorrhea, facial pain , nasal odor, nasal dryness, olfactory disturbance, dizziness or headache.
Nasal VAS Scale Score nasal congestion nasal secretions or posterior rhinorrhea facial pain nasal odor nasal dryness olfactory disturbance dizziness or headache ecah Items were evaluated, with 0 indicating no symptoms and 10 indicating the most severe symptoms
Measured: The first 1 day after the nasal strip is pulled out ( after transsphenoidal pituitary tumor resection)
Secondary outcomes (1)
Quality of life of patients
Use The Chinese version of the commonly used nasosinusitis scale (SNOT -20) to evaluate postoperative quality of life of patients from the four dimensions of rhino-related symptoms, vitality, social function and emotional function.The scale including must blow your nose, sneezing, flow of black nose, coughing, running nose backward flow, flow of mucus nose, ear swelling in feeling, dizziness, ear pain, pain oppressive feeling, difficult to sleep, sleep wake up at night, lack of high quality sleep, wake up after fatigue, fatigue, lower productivity, inattention, depressed agitation angry, sad, embarrassed 20 items, each item can be divided into no trouble (0), mild difficulties (1), medium (2 points), severe (3 points),The higher the score in the four dimensions of nasal symptoms, vitality, social function and emotional function, respectively, the more serious the problems in the relevant dimensions are, so as to evaluate the quality of life of patients.
Measured: The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Aug 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Wei, Bachelor, Study director, seconf Affiliated Hospital, School of Medicine, Zhejiang University,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933241
- Sponsor's protocol ID
- Research2019-069
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 20 May 2019
- Results posted
- No
- 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 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Saline Nasal Irrigation in Patients After Transsphenoidal Pituitary Tumor Resection
- ClinicalTrials.gov ID
- NCT03933241
- Acronym / sponsor ID
- Research2019-069
- Conditions
- Pituitary Tumor
- Keywords
- nasal irrigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 1 May 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.
Transsphenoidal pituitary tumor resection is currently recognized as an effective and safe surgical method,nowadays it is widely used in clinical practice . However ,Because of the endoscopic damage to the nasal mucosa during surgery and the old blood clots in the nasal cavity , after surgery the patient had nasal symptoms such as nasal congestion and nasal flow for a long time, which disturbed the patient's rest and sleep, affect their quality of life, some patients can develop to chronic sinus inflammation that is sphenoid sinusitis. Nasal irrigation is now widely used in the treatment of sinusitis and sphenoid sinusitis with good result. In this study, nasal irrigation was applied in the nursing process of patients after transsphenoidal pituitary tumor resection, and we want to establish the nursing management process of nasal irrigation after transsphenoidal pituitary tumor resection and use the visual analogue scale (VAS) to evaluate the nasal symptoms of patients after postoperative nasal irrigation. Use The Chinese version of the commonly used nasosinusitis scale (SNOT -20) to evaluate postoperative quality of life of patients from the four dimensions of rhino-related symptoms, vitality, social function and emotional function, and to evaluate the incidence of sphenoid sinusitis by combining imaging examination. It is expected to improve the comfort of postoperative nasal symptoms and postoperative quality of life, prevent and reduce the incidence of postoperative sphenoid sinusitis, and improve the satisfaction of patients.
Detailed description
Eligible patients who were willing to participate in transsphenoidal pituitary tumor resection after informed consent were selected as the study subjects,Randomly divided into experimental group and control group. The experimental group apply the routine postoperative nursing process of transsphenoidal pituitary tumor plus nasal irrigation nursing process, the control group apply the routine postoperative nursing process of transsphenoidal pituitary tumor .After the removal of nasal gauze,we use visual analogue scale (VAS) to score and observe the clinical symptoms of nasal cavity in both groups. The patients were asked to mark out the score that could represent the severity of their symptoms for evaluation. The nurses filled in the form, and the nasal comfort was re-evaluated through face-to-face talks and telephone follow-up at two days ,1 week, 4 weeks and 12 weeks after the removal of the gauze.we will apply nasosinusitis scale (SNOT -20) to measure the quality of life of the patients in the two groups at the first day, 1 week, 4 weeks and 12 weeks after the removal of nasal strips .After 12 weeks of discharge, two groups of patients were hospitalized for reexamination with pituitary MRI or CT,to determine the incidence of postoperative sphenoid sinusitis.Patients were followed up and interviewed by telephone one week, four weeks and 12 weeks after discharge, were evaluate the incidence of complications such as nasal bleeding, cerebrospinal fluid leakage and intracranial infection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Behavioral: nasal irrigationnasal irrigation after transsphenoidal surgery for pituitary tumor |
| matched group | No intervention | –without nasal irrigation after transsphenoidal surgery for pituitary tumor |
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients after transsphenoidal pituitary tumor resection
- Patients who can cooperate with nasal irrigation, scoring and informed consent
Key exclusion criteria (4 listed)
- Patients with incomplete clinical data
- Patients with cerebrospinal fluid rhinorrhea during and after surgery (patients with cerebrospinal fluid leakage under intraoperative endoscopic observation and cerebrospinal fluid leakage when postoperative posture changes)
- patients with sphenoid sinusitis before transsphenoidal pituitary tumor resection
- Patients who cannot cooperate with the investigation
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 |
|---|---|---|
| nasal irrigationnasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor | Behavioural | experiment group |
Primary outcome
Nasal symptoms of patients
Time frame: The first 1 day after the nasal strip is pulled out ( after transsphenoidal pituitary tumor resection)
Use the visual analogue scale (VAS) to evaluate the nasal symptoms of patients after postoperative nasal irrigation. Evaluation of symptoms including nasal congestion, nasal secretions or posterior rhinorrhea, facial pain , nasal odor, nasal dryness, olfactory disturbance, dizziness or headache. Nasal VAS Scale Score nasal congestion nasal secretions or posterior rhinorrhea facial pain nasal odor nasal dryness olfactory disturbance dizziness or headache ecah Items were evaluated, with 0 indicating no symptoms and 10 indicating the most severe symptoms
1 secondary outcome
Quality of life of patients
Time frame: The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Wang Wei, Bachelor study director
seconf Affiliated Hospital, School of Medicine, Zhejiang University,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal irrigation in people with Pituitary Tumor, 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 20 May 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 Wang Wei, Bachelor (15888841161, 2191043@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal symptoms of patients (time frame: The first 1 day after the nasal strip is pulled out ( after transsphenoidal pituitary tumor resection)). 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 20 May 2019.