Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pituitary Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single blinded study, only the participant is blinded to the group he is going to be in.

Study Groups

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Double nasoseptal flap

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.

Group Type EXPERIMENTAL

Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique

Intervention Type PROCEDURE

Patients with with symptomatic pituitary macroadenoma and tumor size ≥ 2 cm will have transsphenoidal endoscopic excision of pituitary adenoma.

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

Rescue nasoseptal flap

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).

Group Type EXPERIMENTAL

Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique

Intervention Type PROCEDURE

Patients with with symptomatic pituitary macroadenoma and tumor size ≥ 2 cm will have transsphenoidal endoscopic excision of pituitary adenoma.

\- 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).

Interventions

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Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique

Patients with with symptomatic pituitary macroadenoma and tumor size ≥ 2 cm will have transsphenoidal endoscopic excision of pituitary adenoma.

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

Intervention Type PROCEDURE

Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique

Patients with with symptomatic pituitary macroadenoma and tumor size ≥ 2 cm will have transsphenoidal endoscopic excision of pituitary adenoma.

\- 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No