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出境医 / 临床实验 / Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection
Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection
Study Description
Brief 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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pituitary Tumor | Behavioral: nasal irrigation | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 262 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | The Application of Saline Nasal Irrigation in Patients After Transsphenoidal Pituitary Tumor Resection |
| Estimated Study Start Date : | August 1, 2019 |
| Estimated Primary Completion Date : | July 30, 2020 |
| Estimated Study Completion Date : | July 30, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: experiment group
nasal irrigation after transsphenoidal surgery for pituitary tumor
|
Behavioral: nasal irrigation
nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor
|
|
No Intervention: matched group
without nasal irrigation after transsphenoidal surgery for pituitary tumor
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Quality of life of patients [ Time Frame: The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection) ]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.
Other Outcome Measures:
- The incidence of sphenoid sinusitis [ Time Frame: The third month after transsphenoidal surgery for pituitary tumor ]Evaluate the incidence of sphenoid sinusitis by combining imaging examination
Eligibility Criteria
| Ages Eligible for Study: | 15 Years to 74 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients after transsphenoidal pituitary tumor resection
- Patients who can cooperate with nasal irrigation, scoring and informed consent
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Wang Wei, Bachelor | 15888841161 | 2191043@zju.edu.cn |
Locations
| China, Zhejiang | |
| The Second Affiliated hospital of Zhejiang University School of Medicine | Recruiting |
| Hangzhou, Zhejiang, China, 310000 | |
| Contact: Wang Wei, Bachelor 15888841161 2191043@zju.edu.cn | |
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
| Study Director: | Wang Wei, Bachelor | seconf Affiliated Hospital, School of Medicine, Zhejiang University, |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | May 20, 2019 | ||||
| Estimated Study Start Date ICMJE | August 1, 2019 | ||||
| Estimated Primary Completion Date | July 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE |
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.
|
||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
Quality of life of patients [ Time Frame: The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection) ] 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.
|
||||
| Original Secondary Outcome Measures ICMJE |
Quality of life of patients [ Time Frame: The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection) ] 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
|
||||
| Current Other Pre-specified Outcome Measures |
The incidence of sphenoid sinusitis [ Time Frame: The third month after transsphenoidal surgery for pituitary tumor ] Evaluate the incidence of sphenoid sinusitis by combining imaging examination
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection | ||||
| Official Title ICMJE | The Application of Saline Nasal Irrigation in Patients After Transsphenoidal Pituitary Tumor Resection | ||||
| Brief 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 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Pituitary Tumor | ||||
| Intervention ICMJE | Behavioral: nasal irrigation
nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
262 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 30, 2021 | ||||
| Estimated Primary Completion Date | July 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 15 Years to 74 Years (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03933241 | ||||
| Other Study ID Numbers ICMJE | Research2019-069 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Study Sponsor ICMJE | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
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| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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