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Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection

Primary Purpose

Pituitary Tumor

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nasal irrigation
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pituitary Tumor focused on measuring nasal irrigation

Eligibility Criteria

15 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experiment group

matched group

Arm Description

nasal irrigation after transsphenoidal surgery for pituitary tumor

without nasal irrigation after transsphenoidal surgery for pituitary tumor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 29, 2019
Last Updated
May 16, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT03933241
Brief Title
Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection
Official Title
The Application of Saline Nasal Irrigation in Patients After Transsphenoidal Pituitary Tumor Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Tumor
Keywords
nasal irrigation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experiment group
Arm Type
Experimental
Arm Description
nasal irrigation after transsphenoidal surgery for pituitary tumor
Arm Title
matched group
Arm Type
No Intervention
Arm Description
without nasal irrigation after transsphenoidal surgery for pituitary tumor
Intervention Type
Behavioral
Intervention Name(s)
nasal irrigation
Intervention Description
nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor
Primary Outcome Measure Information:
Title
Nasal symptoms of patients
Description
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
Time Frame
The first 1 day after the nasal strip is pulled out ( after transsphenoidal pituitary tumor resection)
Secondary Outcome Measure Information:
Title
Quality of life of patients
Description
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.
Time Frame
The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection)
Other Pre-specified Outcome Measures:
Title
The incidence of sphenoid sinusitis
Description
Evaluate the incidence of sphenoid sinusitis by combining imaging examination
Time Frame
The third month after transsphenoidal surgery for pituitary tumor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Wei, Bachelor
Phone
15888841161
Email
2191043@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Wei, Bachelor
Organizational Affiliation
seconf Affiliated Hospital, School of Medicine, Zhejiang University,
Official's Role
Study Director
Facility Information:
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Wei, Bachelor
Phone
15888841161
Email
2191043@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection

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