The Impact of Endoscopic Pituitary Surgery on Nasal Function

• Conditions: Quality of Life; Function of Nose; Pituitary Tumor; Endoscopic Surgery
• Interventions: Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery; Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery

• Registration Number: NCT04018963
• Lead Sponsor: Zhebao Wu

Brief Summary

The aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．

Detailed Description

Neuroendoscopic surgery is the first treatment for most pituitary adenoma patients. Because transsphenoidal surgery exploits the nasal corridor and paranasal sinuses to reach the skull base, sinonasal trauma is a primary source of postoperative morbidity in many of these patients. The aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-15
• Study Start: 2019-07-25
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Enhanced MRI shows a pituitary tumor
2. Endoscopic surgery is required according to the pituitary tumor treatment guidelines.
3. Karnofsky performance status ≥ 70.
4. The patient has signed the informed consent.

Exclusion Criteria

1. Patients who have undergone previous transsphenoidal surgery or other nasal surgery.
2. Patients who had a history of nasal tumors.
3. Patients who had a history of severe head or face trauma.
4. Patients with congenital sinus malformation.
5. Pregnant or lactating women.
6. Patients with serious systemic diseases without control.
7. Patients with poor compliance, who cannot implement the program strictly.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Binostril group	Bilateral nostril approach endoscopic transsphenoidal pituitary surgery	Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.
Uninostril group	Single nostril approach endoscopic transsphenoidal pituitary surgery	Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.

Primary Outcome Measures

Name	Time	Method
Airflow patterns.	Up to 3 months	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal airflow patterns 3 months after surgery.
Nasal airway patency.	Up to 3 months	A bilateral model of the human nose on a CT-scan will be reconstructed to display geometric parameters of nasal cavity 3 months after surgery.
Temperature parameter.	Up to 3 months	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal temperature parameter 3 months after surgery.
Humidity parameter.	Up to 3 months	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal humidity parameter 3 months after surgery.
CT Lund-Mackay Score	Up to 3 months	Record the CT Lund-Mackay Score 3 months after surgery.The CT Lund-Mackay Score has a maximum score of 24 and a minimum score of 0. Higher values represent a worse outcome.
SNOT-20	Up to 3 months	Record the Sino-Nasal Outcome Record the Test-20(SNOT-20) 3 months after surgery. The SNOT-20 has a maximum score of 60 and a minimum score of 0. Higher values represent a worse outcome.
VAS	Up to 3 months	Record the Visual Analogue Scale(VAS) 3 months after surgery. The VAS scale includes six sub-scales: rhinorrhea VAS, rhinobyon VAS，rhinocnesmus VAS, cough VAS, sneezing VAS and olfaction VAS. Each scale has a maximum score of 10 and a minimum score of 0. The total VAS was the average of all sub-scales. Higher values represent a better outcome.
SF-36	Up to 3 months	Record the Medical Outcome Study Short Form 36-items Health survey(SF-36) 3 months after surgery. The SF-36 includes six sub-scales: General Health, Reported Health Transition，Physical Functioning, Role-Physical, Role-Emotional, Social Functioning, Bodily Pain, Vitality and Mental Health. Each scale has a maximum score of 100 and a minimum score of 0. The total score was the average of all sub-scales. Higher values represent a better outcome.

Secondary Outcome Measures

Name	Time	Method
Temperature parameter.	1 week after surgery	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal temperature parameter 1 week after surgery.
Nasal airway patency.	1 week after surgery	A bilateral model of the human nose on a CT-scan will be reconstructed to display geometric parameters of nasal cavity 1 week after surgery.
Change on Tumor	Up to 3 months	Record the tumor volume from enhanced pituitary MRI 3 months after surgery.
Airflow patterns.	1 week after surgery	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal airflow patterns 1 week after surgery.
Humidity parameter.	1 week after surgery	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal humidity parameter 1 week after surgery.
SF-36	1 week after surgery	Record the Medical Outcome Study Short Form 36-items Health survey(SF-36) 1 week after surgery. The SF-36 includes six sub-scales: General Health, Reported Health Transition，Physical Functioning, Role-Physical, Role-Emotional, Social Functioning, Bodily Pain, Vitality and Mental Health. Each scale has a maximum score of 100 and a minimum score of 0. The total score was the average of all sub-scales. Higher values represent a better outcome.
VAS	1 week after surgery	Record the Visual Analogue Scale(VAS) 1 week after surgery. The VAS scale includes six sub-scales: rhinorrhea VAS, rhinobyon VAS，rhinocnesmus VAS, cough VAS, sneezing VAS and olfaction VAS. Each scale has a maximum score of 10 and a minimum score of 0. The total VAS was the average of all sub-scales. Higher values represent a better outcome.
SNOT-20	1 week after surgery	Record the Sino-Nasal Outcome Record the Test-20(SNOT-20) 1 week after surgery. The SNOT-20 has a maximum score of 60 and a minimum score of 0. Higher values represent a worse outcome.
CT Lund-Mackay Score	1 week after surgery	Record the CT Lund-Mackay Score 1 week after surgery. The CT Lund-Mackay Score has a maximum score of 24 and a minimum score of 0. Higher values represent a worse outcome.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China