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The effects of intradural optic canal decompression on the visual outcome in suprasellar meningiomas resection

Protocol summary

Study aim
The effects of intradural optic canal decompression on the visual outcome in suprasellar meningiomas resection
Design
This is a randomized, double-blind clinical trial with parallel groups. Surgery type will be determined using sealed envelopes and divided into two groups of resection with and without intradural decompression of the optic canal. The sample size is 13 patients in each group.
Settings and conduct
This study is performed in Imam Khomeini Hospital. All individuals undergo a fundoscopy one week before surgery to check visual acuity, visual field, and optic nerve status. Tumor size and imaging data will also be recorded. All patients will be hospitalized in the ICU and ward for at least one and 3 days respectively. Any complications during this period will be recorded. After discharge, patients will be referred to Neurosurgery Clinic for follow-up and re-examination one week, one month, and 3 months after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with a diagnosis of suprasellar meningioma, candidates for tumor resection who have at least one eye with visual acuity above 0.1 and below 0.7. Exclusion criteria: non-meningioma visual problems, no consent, recurrence of the tumor in the same area, involvement of the optic nerve, major psychiatric disorders, inability to perform MRI
Intervention groups
control group: These patients will undergo craniotomy and mass resection. intervention group: craniotomy and mass resection plus, up to a maximum of 1 cm of canal ceiling will be removed with a surgical drill under a microscopic guide just before the tumor resection begins. Then falciform ligament will open. The eye with lower visual acuity on the examination will be selected for decompression.
Main outcome variables
Visual acuity, visual field, visual complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220319054332N1
Registration date: 2022-04-03, 1401/01/14
Registration timing: prospective

Last update: 2022-04-03, 1401/01/14
Update count: 0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Arad Iranmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2635
Email address
a-iranmehr@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intradural optic canal decompression on the visual outcome in suprasellar meningiomas resection
Public title
The effects of intradural optic canal decompression on the visual outcome in suprasellar meningiomas resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of suprasellar meningioma based on clinical examination and imaging findings. Candidates for tumor resection surgery. On visual examination, at least one eye should have a visual acuity above 0.1 and below 0.7.
Exclusion criteria:
Patients with visual impairment due to damage to the retina, optic nerve, chiasm, or visual cortex for reasons other than suprasellar meningiomas are excluded. Patients who do not agree to continue participating at any stage of the study. Patients who present with tumor recurrence in the same area. Patients who have been diagnosed with a non-meningioma tumor after postoperative pathology report. Patients whose optic nerve is affected by a tumor during surgery Patients with visual acuity below 0.1 in both eyes during the initial preoperative examination. Patients with visual acuity above 0.7 in both eyes during preoperative examinations. Patients with major psychiatric disorders. Patients who do not have adequate access to follow-up at scheduled times. Patients who have a severe reaction to a contrast agent, a metal heart valve, a pacemaker, a non-titanium metal clip, and fear of confinement will not be able to have an MRI.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups using a sealed envelope and receive the intervention of the same group. The type of surgery is pre-divided evenly on sheets and sealed in special envelopes. After determining the operation time for each patient, one of the envelopes is opened randomly and the type of patient operation is determined based on its contents.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blinded. Patients are blinded to the type of interventions. Patients will then be coded by one of the study partners and the researcher, outcome evaluator, data analyzer will be blinded to the patient group and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1445983861
Approval date
2021-01-03, 1399/10/14
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.386

Health conditions studied

1

Description of health condition studied
suprasellar meningiomas
ICD-10 code
D32.9
ICD-10 code description
Benign neoplasm of meninges, unspecified

Primary outcomes

1

Description
Comparison of the improving the vision of patients with and without intradural decompression of the optic canal after surgery
Timepoint
3 days, a week, a month, three months after surgery
Method of measurement
Snellen chart or Computerized tests

Secondary outcomes

1

Description
Comparison of the incidence of surgical complications of suprasellar meningiomas in patients with and without intradural decompression of the optic canal
Timepoint
Three days after admission to the ward
Method of measurement
Based on history and examinations

Intervention groups

1

Description
Control group: Tumor resection group without intradural decompression of the optic canal
Category
Treatment - Surgery

2

Description
Intervention group: Tumor resection group with intradural decompression of the optic canal
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Arad Iranmehr
Street address
Imam Khomeini Hospital Complex, Tohid Squre
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2636
Email
imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Vice Chancellor for Research and Technology, 6th floor, Central University Organization, Felestin St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arad Iranmehr
Position
Neurosurgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
00982161190
Fax
Email
a-iranmehr@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arad Iranmehr
Position
Clinical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Imam Khomeini hospital, Tohid sq., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2635
Fax
Email
a-iranmehr@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arad Iranmehr
Position
Clinical Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Imam Khomeini hospital, Tohid sq., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2635
Fax
Email
a-iranmehr@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical data, treatment outcomes, radiological and ophthalmic findings, and demographic data
When the data will become available and for how long
The access period starts 10 months after the results are published
To whom data/document is available
public
Under which criteria data/document could be used
Detailed study information can be provided to qualified researchers interested in treating patients.
From where data/document is obtainable
corresponded author of article
What processes are involved for a request to access data/document
Competent and enthusiastic researchers can obtain data documents after the publication of the work from the corresponded author by providing academic information and identification.
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