Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

August 9, 2024 updated by: Mansoura University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University, Department of otorhinolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double nasoseptal flap

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

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.
Experimental: Rescue nasoseptal flap

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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal morbidity
Time Frame: at 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.
at baseline preoperative and 1 month and 3 months postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative data
Time Frame: at time of surgery
Operative time
at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmad M. Al-Arman, Mansoura Faculty of Medicine, Masnoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2022

Primary Completion (Actual)

March 26, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 28, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.22.11.721

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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