Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection

NCT03933241 | Unknown

• 1 other identifier: Research2019-069
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor

Keywords

nasal irrigation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life of patients

  The first 1 day after the nasal strip is pulled out (after transsphenoidal pituitary tumor resection)

Other Outcomes (1)

• The incidence of sphenoid sinusitis

  The third month after transsphenoidal surgery for pituitary tumor

Study Arms (2)

experiment group

EXPERIMENTAL

nasal irrigation after transsphenoidal surgery for pituitary tumor

Behavioral: nasal irrigation

matched group

NO INTERVENTION

without nasal irrigation after transsphenoidal surgery for pituitary tumor

Interventions

nasal irrigation BEHAVIORAL

nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor

experiment group

Eligibility Criteria

• Age: 15 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients after transsphenoidal pituitary tumor resection
• Patients who can cooperate with nasal irrigation, scoring and informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Wang Wei, Bachelor

  seconf Affiliated Hospital, School of Medicine, Zhejiang University,

  STUDY DIRECTOR

Central Study Contacts

Wang Wei, Bachelor

CONTACT

15888841161; 2191043@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: August 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2021
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)