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Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06526481
Enrollment
56
Registered
2024-07-29
Start date
2022-12-12
Completion date
2024-07-01
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Adenoma

Keywords

pituitary surgery, double nasoseptal flap, rescue nasoseptal flap, nasal morbidity, transsphenoidal pituitary surgery

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREEndoscopic 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.

PROCEDUREEndoscopic 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).

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Nasal morbidityat 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

MeasureTime frameDescription
Operative dataat time of surgeryOperative time

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026