Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal Functions
Condition: Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Study type: Interventional

Summary: 
      The aim of the project is to compare the effect of different extent of resection of the
      posterior part of the septum on the postoperative nasal functions.
    

Detailed description: 
      The nasal cavity is used to heat, humidify and purify the air before entering other parts of
      the respiratory system. Other functions of the nose include in particular olfactory, immune,
      reflex or sexual functions.

      Proper airflow through the nasal cavity is essential for all nasal functions; anatomical or
      flow changes can significantly affect nasal functions.

      Endoscopic transnasal surgical approaches are modern, mini-invasive methods, enabling
      solution of pathologies in the area of the cranial base, through the nasal cavity. The
      advantage of this technique is absence of external incisions and scars and significantly
      better cosmetic effect, these methods also offer very good clarity and illumination of the
      operating field. Main disadvantage is risk of affecting functions of the nose.

      To create a transnasal approach to skull base, it is necessary to perform lateralization of
      middle turbinates, resection of anterior wall of sphenoidal sinus and resection of posterior
      part of the nasal septum. These interventions are necessary for a good overview and
      manipulation in the operated area; however, they can lead to postoperative changes in the
      physiological functions of the nasal cavity, especially loss of smell, taste, altered airflow
      through the nasal cavity, mucociliary transport disorders, nasal obstruction, crusting or
      drying mucous membrane. All these adverse changes significantly affect patient's quality of
      life.

      Larger extent of septal resection allows the surgeon to have a better overview and
      manoeuvrability in the operated area, which allows sufficient radicality and allows the
      solution of possible complications. On the other hand, greater resection also means greater
      interference with the anatomy of the nasal cavity and possible influence on nasal functions.

      The aim of the project is to compare the effect of different extent of resection of the
      posterior part of the septum on the postoperative nasal functions.

      Study design:

        -  all operations will be performed by the same operations team

        -  prior to surgery, patients will be randomly tossed into two groups according to the
           extent of resection of the posterior edge of the septum as part of the transsphenoidal
           approach during cranial base surgery

        -  group A - Patients will be resected with a posterior 1 cm nasal septum as part of a
           transsphenoidal approach.

        -  group B - Patients will be resected with a 2 cm posterior nasal septum as part of a
           transsphenoidal approach

        -  if the selected extent of resection is not sufficient during surgery for group A, it
           will be extended so that the lesion can be safely removed, and patient will be removed
           from study

      Operational procedure:

        1. Anemization of the nasal mucosa using strips with diluted adrenaline 1: 1000.

        2. Endoscopy of the nasal cavity and identification of important anatomical structures.

        3. Lateralization of the middle and upper turbinates, identification of the anterior wall
           of the sphenoidal sinus and its natural ostium.

        4. Apply suction with a marked distance of 1 and 2 cm to the septum and mark the extent of
           laser resection on the septal mucosa.

           The suction is applied paraseptally to the anterior wall of the sphenoidal sinus at the
           height of the natural ostium (1.5 cm above the upper edge of the choana), the caudal
           border of the resection is the height of the upper edge of the choana, the cranial
           border is the ceiling of the sphenoid.

        5. Resection of the septum in the given range.

        6. Resection of the anterior wall of the sphenoidal sinus, resection of the intersphenoidal
           septum.

        7. Rest of the operation is identical in both groups of patients (tumour resection,
           revision of the nasal cavity, nasal tamponade).

             -  At preoperative examination and 1 month after surgery, patients will have:

             -  endoscopy of the nasal cavity with Lund-Kennedy scoring system (evaluation of
                oedema, secretion, crust)

             -  olfactory examination - test of identification and discrimination with perfumed
                markers

             -  SNOT 22 questionnaire

             -  RhinoVAS questionnaire

             -  Nose score

      Statistical evaluation:

        -  comparison of nasal functions after cranial base surgery in patients with a range of
           resection of the posterior edge of the septum 1 cm and 2 cm

        -  comparison of olfactory before and after surgery in both groups of patients
    

Intervention name(s): Posterium nasal septum resection
Intervention type(s): Procedure
Intervention description(s): Posterium nasal septum resection is required to ensure approach during transnasal endoscopic pituitary surgery in patients with pituitary adenoma.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study subjects will be randomised into two parallel groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pituitary adenoma; nasal functions; posterior nasal septum resection; transnasal approach; endoscopic pituitary surgery