Nasal Irrigation Apply in Patients After Transsphenoidal Pituitary Tumor Resection

NCT ID: NCT03933241

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-07-30

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.

Conditions

Pituitary Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

experiment group

nasal irrigation after transsphenoidal surgery for pituitary tumor

Group Type: EXPERIMENTAL

nasal irrigation

Intervention Type: BEHAVIORAL

nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor

matched group

without nasal irrigation after transsphenoidal surgery for pituitary tumor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

nasal irrigation

nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang Wei, Bachelor

Role: STUDY_DIRECTOR

seconf Affiliated Hospital, School of Medicine, Zhejiang University,

Locations

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Wei, Bachelor

Role: CONTACT

2191043@zju.edu.cn

15888841161

Facility Contacts

Wang Wei, Bachelor

Role: primary

2191043@zju.edu.cn

15888841161

Other Identifiers

Research2019-069

Identifier Type: -

Identifier Source: org_study_id