Pituitary AdenomaNCT06526481
Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
A study testing Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique and Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique in people with Pituitary Adenoma, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique and Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All consecutive patients with symptomatic pituitary macroadenoma
- Tumor size ≥ 2 cm
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pituitary Adenoma
- Being tested
- Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique, Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique
- Keywords
- pituitary surgery, double nasoseptal flap, rescue nasoseptal flap, nasal morbidity, transsphenoidal pituitary surgery
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap TechniqueProcedure or surgery
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.
Endoscopic Transsphenoidal pituitary surgery : Rescue Flap TechniqueProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline preoperative and 1 month and 3 months postoperative.
Secondary outcomes (1)
Operative data
Operative time
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start12 Dec 2022
- Primary completion26 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad M. Al-Arman, Principal investigator, Mansoura Faculty of Medicine, Masnoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526481
- Sponsor's protocol ID
- MD.22.11.721
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery
- ClinicalTrials.gov ID
- NCT06526481
- Acronym / sponsor ID
- MD.22.11.721
- Conditions
- Pituitary Adenoma
- Keywords
- pituitary surgery, double nasoseptal flap, rescue nasoseptal flap, nasal morbidity, transsphenoidal pituitary surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double nasoseptal flap | Experimental | Procedure: Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap TechniqueNasoseptal 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. |
| Rescue nasoseptal flap | Experimental | Procedure: Endoscopic Transsphenoidal pituitary surgery : Rescue Flap TechniqueNasoseptal 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All consecutive patients with symptomatic pituitary macroadenoma
- Tumor size ≥ 2 cm
Key exclusion criteria (7 listed)
- -Absent sphenoid pneumatization.
- Temporal or frontal extension.
- Recurrent pituitary tumor after previous surgery.
- Previous nasal surgery.
- Associated nasal disease e.g. rhinosinusitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap TechniquePatients 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. | Procedure or surgery | Double nasoseptal flap |
| Endoscopic Transsphenoidal pituitary surgery : Rescue Flap TechniquePatients 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). | Procedure or surgery | Rescue nasoseptal flap |
Primary outcome
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.
1 secondary outcome
Operative data
Time frame: at time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad M. Al-Arman principal investigator
Mansoura Faculty of Medicine, Masnoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Transsphenoidal pituitary surgery : Double Nasoseptal Flap Technique and Endoscopic Transsphenoidal pituitary surgery : Rescue Flap Technique in people with Pituitary Adenoma, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal morbidity (time frame: at baseline preoperative and 1 month and 3 months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.