Endoscopic Surgery, Function of Nose, Pituitary Tumor, Quality of Life
Conditions
Keywords
Pituitary tumor, Neuroendoscope, Surgical approach, Computational Fluid Dynamics, Numerical simulation
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)．
Interventions
PROCEDURESingle nostril approach endoscopic transsphenoidal pituitary surgery
Single nostril approach endoscopic transsphenoidal pituitary surgery
PROCEDUREBilateral nostril approach endoscopic transsphenoidal pituitary surgery
Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
Sponsors
Shanghai Zhongshan Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
The First Affiliated Hospital of Nanchang University
Zhebao Wu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change on Tumor | Up to 3 months | Record the tumor volume from enhanced pituitary MRI 3 months after surgery. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactWeiting Gu, Phd
Outcome results
None listed