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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection

Clinicaltrials.gov identifier NCT03933241

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 20, 2019

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:Pituitary Tumor
  • Intervention/Treatment: Behavioral: nasal irrigation
  • Phase: N/A
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
  • 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 2019
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: July 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
Outcome Measures
  • Primary Outcome Measures: 1. 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: 1. 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: 1. 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 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
Hangzhou

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,

More Information
  • Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
  • ClinicalTrials.gov Identifier: NCT03933241 History of Changes
  • Other Study ID Numbers: Research2019-069
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 20, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: nasal irrigation
  • Additional relevant MeSH terms: Pituitary Neoplasms Pituitary Diseases