A Clinical Trial to Study the Effects on the Olfaction Capacity of an Individual Undergoing Skull Base Surgeries Using Cautery vs Scalpel .

ConditionOlfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAll India Institute of Medical Sciences, Jodhpur

About this trial

Olfaction is a prominent entity that determines a person's quality of life. During human evolution, olfaction has played an essential role in determining safe food, assessing threats, and developing social relationships. Endoscopic endonasal surgeries are widely used today for the removal of brain tumors involving the pituitary and skull base. The minimal invasiveness, rapid recovery, better visualization, and lower occurrence of complication make endonasal endoscopic surgery an ideal approach for tumors involving the pituitary and midline skull base. However, the olfactory epithelium is at risk of injury during endoscopic skull base surgeries due to the orientation of the olfactory epithelium fibers.It has been found that the olfactory neuroepithelium extends from the cribriform plate superiorly to the septum for the superior-most 1 to 2 cm medially and onto the upper half of the superior turbinates laterally.It also extends from the face of the sphenoid posteriorly to the attachment of the middle turbinate anteriorly.This makes the olfactory fibers susceptible to injury during endonasal surgery that requires superior or upper limb septal incisions, such as the pedicled nasoseptal flap (the Hadad-Bassagasteguy flap) and modified nasoseptal rescue flap.It has been debated whether using a scalpel instead of cautery could have a differential effect on the olfaction of an individual, as some surgeons believe that the heat generated by a cautery injures the nearby olfactory mucosa.This study aims at determining the method which is better at preserving the olfactory capacity of an individual undergoing endoscopic endonasal skull base surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with preoperative anosmia due to any cause.

Patients with a previous history of sino-nasal, pituitary, or skull base surgery.

Patients with a medical history of neurodegenerative diseases (for example, Alzheimer's disease or Parkinson's disease), chronic rhinosinusitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scalpel

    Procedure/Surgery

    During endoscopic endonasal skull base surgery,scalpel will be used to elevate the nasoseptal flap.

  • Cautery

    Procedure/Surgery

    During endoscopic endonasal skull base surgery,cautery will be used to elevate the nasoseptal flap.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Combined Olfactory Score (I-smell test)

Threshold odour identification score and specific odour identification score will be added to form a Combined Olfactory Score.

Time frame
Preoperatively,Immediate postoperatively,3-6 months postoperatively
2

Visual Analogue Scale (VAS)

Visual analogue scale scoring from 0-10 to measure olfaction. (with higher score indicating better olfaction capacity)

Time frame
Preoperatively,Immediately postoperatively,3-6 months postoperatively

Secondary outcomes

1

22-item Sino Nasal Outcome Test (SNOT-22) questionnaire

It covers a range of sinonasal symptoms and their impact on social and emotional well-being

Time frame
Preoperatively,Immediate postoperatively,3-6 months postoperatively

Other outcomes

Sponsors and contacts

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