Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

Mansoura University

Status: Completed

Conditions: Pituitary Adenoma

Treatments: Procedure: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique; Procedure: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06526481

MD.22.11.721

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All consecutive patients with symptomatic pituitary macroadenoma
• Tumor size ≥ 2 cm

Exclusion criteria

• -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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Double nasoseptal flap

Experimental group

Description:

Nasoseptal double flap group: -On one side full sized nasoseptal flap will be elevated and a smaller sized nasoseptal flap will be elevated on the other side.

Treatment:

Procedure: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique

Rescue nasoseptal flap

Experimental group

Description:

Nasoseptal rescue flap group: - A horizontal incision will be performed in the nasal septum in a posterior to anterior direction starting from the sphenoid ostium to a point opposite anterior end of the middle turbinate ( approximately up to one half of septum).

Treatment:

Procedure: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique