Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

NCT06526481 | Completed

• 1 other identifier: MD.22.11.721
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Nasal morbidity

  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.

  at baseline preoperative and 1 month and 3 months postoperative.

Secondary Outcomes (1)

• Operative data

  at time of surgery

Study Arms (2)

Double nasoseptal flap

EXPERIMENTAL

Nasoseptal double flap group: -On one side full sized nasoseptal flap will be elevated and a smaller sized nasoseptal flap will be elevated on the other side.

Procedure: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique

Rescue nasoseptal flap

EXPERIMENTAL

Nasoseptal rescue flap group: \- 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).

Procedure: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique

Interventions

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.

Double nasoseptal flap

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).

Rescue nasoseptal flap

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients with symptomatic pituitary macroadenoma
• Tumor size ≥ 2 cm

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Department of otorhinolaryngology

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmad M. Al-Arman

  Mansoura Faculty of Medicine, Masnoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded study, only the participant is blinded to the group he is going to be in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 29, 2024
• Study Start: December 12, 2022
• Primary Completion: March 26, 2024
• Study Completion: July 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-07

Locations

EG (1)