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NCT Number: NCT06526481

Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

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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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Department of otorhinolaryngology

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique

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.

Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique

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).

Primary outcomes

  1. Nasal morbidity

    Time frame: 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 outcomes

  1. Operative data

    Time frame: at time of surgery

    Operative time

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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