Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
- Conditions
- Pituitary Adenoma
- Registration Number
- NCT06526481
- Lead Sponsor
- Mansoura University
- Brief Summary
This paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. The nasoseptal flap technique has significantly reduced the incidence of postoperative Cerebrospinal Fluid (CSF) leaks but can cause nasal morbidity.
- Detailed Description
The study aims to compare nasal morbidity and function between the two techniques in patients undergoing this type of surgery. Each patient's nasal morbidity, olfaction, and postoperative complications will be assessed using various tools.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- All consecutive patients with symptomatic pituitary macroadenoma
- Tumor size ≥ 2 cm
- -Absent sphenoid pneumatization.
- Temporal or frontal extension.
- Recurrent pituitary tumor after previous surgery.
- Previous nasal surgery.
- Associated nasal disease e.g. rhinosinusitis.
- Unfit for general anesthesia.
- Refusal of surgical intervention or signing consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Nasal morbidity at baseline preoperative and 1 month and 3 months postoperative. Sinonasal Outcome Test 22 (SNOT-22) arabic translation questionnaire for nasal morbidity SinoNasal Outcome Test - 22 abbreviated (SNOT-22) includes 22 items for assessment by the patient. Each item is graded from 0 to 5. The minimum score is 0. The maximum score is 110. High score means higher nasal morbidity. Low scores mean better nasal morbidity.
- Secondary Outcome Measures
Name Time Method Operative data at time of surgery Operative time
Trial Locations
- Locations (1)
Mansoura University, Department of otorhinolaryngology
🇪🇬Mansoura, Egypt