Clinical trial · Interventional
Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery
Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery: A Single-blinded Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pituitary tumours have an estimated prevalence of 20% in the general population and the number of clinically relevant pituitary adenomas is increasing with time. When symptomatic, the standard of care required for pituitary adenomas is resection through an endoscopic transsphenoidal approach. There is however significant olfactory dysfunction following endoscopic transsphenoidal pituitary surgery with approximately 23% of patients reporting some degree of worsening in their sense of smell in the postoperative period. Pedicled nasoseptal flaps are used to repair skull base defects following resection of skull base tumours. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. The use of electrocautery in surgery has provided surgeons with greater hemostasis when compared to a scalpel. This is of utmost importance in many regions of the head \& neck where highly vascularized tissue results in difficulties achieving adequate hemostasis and therefore limiting view of the surgical field. However, the use of electrocautery increases thermal damage to surrounding tissue and impairs wound healing when compared to a scalpel. Although the transmission of thermal energy via electrocautery to adjacent mucosa containing olfactory epithelium may theoretically contribute to olfactory disturbances, no prospective randomized controlled trials have yet examined the impact of these two different techniques on postoperative olfactory function. The purpose of this research study is to determine the effects, if any, of electrocautery versus scalpel on olfaction in raising the nasoseptal flap for repairing skull base defects following transphenoidal surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Olfactory Nerve Injuries | — | UNRESOLVED | — |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrocautery versus scalpel | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Electrocautery group
- description
- Electrocautery used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.
- interventionNames
- Procedure: Electrocautery versus scalpel
- type
- ACTIVE_COMPARATOR
- label
- Scalpel group
- description
- Scalpel used to raise pediclued nasoseptal flaps to repair skull based defects following endoscopic transphenoidal surgery.
- interventionNames
- Procedure: Electrocautery versus scalpel
Primary outcomes (5)
- measure
- Change in University of Pennsylvania Smell Identification Test (UPSIT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (age ≥18 years) * Patients with tumours of the pituitary gland electively scheduled for endoscopic transsphenoidal surgery with nasoseptal flap coverage Exclusion Criteria: * Documented evidence of sinonasal disease on either nasal endoscopy or radiography * Patients with a clinical history of asthma and/or sinonasal disease * Previous sinus surgery * Previous skull base surgery * History of pre-existing hyposmia or anosmia * Use of medication(s) known to alter sense of smell at time of test * UPSIT scores \<5 indicating a functional component to alteration in olfaction * Development of postoperative cerebrospinal fluid leak necessitating re-entry into the operative field containing the nasoseptal flap
References
Publications (0)
Data not yet available