The Impact of Endoscopic Pituitary Surgery on Nasal Function

Zhebao Wu

Status: Unknown

Conditions: Function of Nose; Quality of Life; Pituitary Tumor; Endoscopic Surgery

Treatments: Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery; Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04018963

NSPA-2019

Details and patient eligibility

About

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)．

Full 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)．

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Uninostril group

Description:

Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.

Treatment:

Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery

Binostril group

Description:

Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.

Treatment:

Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery