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出境医 / 临床实验 / The Impact of Endoscopic Pituitary Surgery on Nasal Function
The Impact of Endoscopic Pituitary Surgery on Nasal Function
Study Description
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)．
| Condition or disease | Intervention/treatment |
|---|---|
| Pituitary Tumor Endoscopic Surgery Quality of Life Function of Nose | Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery |
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 Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery. |
| Actual Study Start Date : | July 25, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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Uninostril group
Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.
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Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery
Single nostril approach endoscopic transsphenoidal pituitary surgery
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Binostril group
Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.
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Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
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Outcome Measures
Primary Outcome Measures :
- Nasal airway patency. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 :
- Change on Tumor [ Time Frame: Up to 3 months ]Record the tumor volume from enhanced pituitary MRI 3 months after surgery.
- Nasal airway patency. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- VAS [ Time Frame: 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated with endoscopic surgery
Criteria
Inclusion Criteria:
- Enhanced MRI shows a pituitary tumor
- Endoscopic surgery is required according to the pituitary tumor treatment guidelines.
- Karnofsky performance status ≥ 70.
- The patient has signed the informed consent.
Exclusion Criteria:
- Patients who have undergone previous transsphenoidal surgery or other nasal surgery.
- Patients who had a history of nasal tumors.
- Patients who had a history of severe head or face trauma.
- Patients with congenital sinus malformation.
- Pregnant or lactating women.
- Patients with serious systemic diseases without control.
- Patients with poor compliance, who cannot implement the program strictly.
Contacts and Locations
Contacts
| Contact: Weiting Gu, Phd | +86-021-64370045 | nowaiting1221@hotmail.com |
Locations
| China, Shanghai | |
| Ruijin Hospital | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Weiting Gu +8602164370045 ext +8602164370045 nowaiting1221@hotmail.com | |
Sponsors and Collaborators
Zhebao Wu
Shanghai Zhongshan Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
The First Affiliated Hospital of Nanchang University
Investigators
| Principal Investigator: | Zhebao Wu, phd | Ruijin Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 10, 2019 | ||||
| First Posted Date | July 15, 2019 | ||||
| Last Update Posted Date | October 9, 2020 | ||||
| Actual Study Start Date | July 25, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Impact of Endoscopic Pituitary Surgery on Nasal Function | ||||
| Official Title | Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery. | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated with endoscopic surgery | ||||
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2021 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04018963 | ||||
| Other Study ID Numbers | NSPA-2019 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Zhebao Wu, Ruijin Hospital | ||||
| Study Sponsor | Zhebao Wu | ||||
| Collaborators |
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| Investigators |
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| PRS Account | Ruijin Hospital | ||||
| Verification Date | October 2020 | ||||
