Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection

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.

Study Overview

• Status: Unknown
• Conditions: Pituitary Tumor
• Intervention / Treatment: Behavioral: nasal irrigation

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: Interventional
• Enrollment (Anticipated): 262
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Wei, Bachelor; Phone Number: 15888841161; Email: 2191043@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Wang Wei, Bachelor; Phone Number: 15888841161; Email: 2191043@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 72 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The first 1 day after the nasal strip is pulled out ( after transsphenoidal pituitary tumor resection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of sphenoid sinusitis	Evaluate the incidence of sphenoid sinusitis by combining imaging examination	The third month after transsphenoidal surgery for pituitary tumor

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Wang Wei, Bachelor, seconf Affiliated Hospital, School of Medicine, Zhejiang University,

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: nasal irrigation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: Research2019-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No