Brain TumorNCT06417658
Comparing Cosmetic Outcomes: Endoscopic vs. Conventional Craniotomy for Frontal Skull Base Lesions
A study testing Endoscopic Supraorbital Eyebrow Craniotomy and Conventional Frontal Craniotomy in people with Brain Tumor, run by University of Health Sciences Lahore.
Trial summary
This research study will compare the cosmetic outcomes, specifically scar assessment and complications, between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Endoscopic Supraorbital Eyebrow Craniotomy and Conventional Frontal Craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 2 Feb 2025
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having frontal skull base lesion on MRI
- Lesion size <5cm on MRI with IV contrast
- Both male and female
- 25-65 years of age
Who cannot join
- Patients with redo surgery (on medical record)
- Lesion size >5cm
- Vascular tumors
- Previous trauma
- Anticoagulant medications
- Comorbidities(uncontrolled hypertension and diabetes)
- Skin diseases
About this study
Official title: A Comparison of Cosmetic Results in Terms of Scar Assessment and Complications in Endoscopic Supraorbital Eyebrow Craniotomy vs Conventional Craniotomy for Frontal Skull Base Lesions
This research study will compare the cosmetic outcomes, specifically scar assessment and complications, between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. The study will aim to evaluate the differences in scar appearance, spread, erythema, suture marks, hypertrophy/atrophy, and overall impression between the two approaches using the Scar Cosmesis Assessment Rating (SCAR) scale. Additionally, it will examine patient-reported outcomes such as itch and pain. The study will follow a structured protocol, including random allocation to groups, preoperative assessments, surgery, postoperative follow-ups, and statistical analysis. It will emphasize the importance of understanding cosmetic outcomes to improve patient satisfaction and inform treatment regimens.
Read the detailed description
The proposed research study will undertake a comparative analysis of the cosmetic outcomes associated with two distinct surgical approaches utilized in the treatment of frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. This investigation will primarily focus on evaluating scar assessment and complications arising from these surgical procedures.
- Surgical Approaches: The study will compare two different techniques: the endoscopic supraorbital eyebrow craniotomy, which is a minimally invasive neurosurgical procedure involving a small incision within the eyebrow to access anterior skull base pathologies, and the conventional frontal craniotomy, a traditional approach involving a larger incision.
- Purpose: The primary objective will be to assess and compare the cosmetic outcomes, particularly scar appearance and related complications, between these two surgical methods. The emphasis will lie on evaluating parameters such as scar spread, erythema, suture marks, hypertrophy/atrophy, and overall impression using the Scar Cosmesis Assessment Rating (SCAR) scale.
- Study Protocol: Random Allocation: Patients will be randomly assigned to either the endoscopic supraorbital eyebrow craniotomy group or the conventional frontal craniotomy group. Preoperative Assessment: Comprehensive preoperative evaluations will be conducted to ascertain baseline data and ensure suitability for surgery. Surgery: Patients will undergo the assigned surgical procedure based on random allocation. Postoperative Follow-up: Close monitoring of patients post-surgery to assess scar healing and detect any complications. Data Collection: Data regarding scar assessment, complications, patient-reported outcomes, and other relevant parameters will be collected at specified intervals. Statistical Analysis: Rigorous statistical analysis of collected data will be conducted to draw comparisons and conclusions regarding cosmetic outcomes between the two surgical approaches.
- Patient-Reported Outcomes: In addition to clinician-assessed scar parameters, the study will also consider patient-reported outcomes such as itch and pain, providing a comprehensive understanding of the patient experience following these surgical interventions.
- Significance: The study will underscore the significance of evaluating cosmetic outcomes in neurosurgical procedures, aiming to enhance patient satisfaction and inform treatment decisions. By comparing the two surgical approaches, the research will seek to contribute valuable insights that may lead to the refinement of surgical techniques and improved patient care.
Overall, this proposed research endeavors to offer a detailed examination of the cosmetic results associated with endoscopic supraorbital eyebrow craniotomy versus conventional frontal craniotomy, thereby facilitating informed decision-making and optimizing patient outcomes in the management of frontal skull base lesions.
- Conditions
- Brain Tumor
- Being tested
- Endoscopic Supraorbital Eyebrow Craniotomy, Conventional Frontal Craniotomy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Supraorbital Eyebrow CraniotomyProcedure or surgery
The Endoscopic Supraorbital Eyebrow Craniotomy is a minimally invasive neurosurgical procedure used to access and remove brain tumors located in the anterior skull base region. In this approach, surgeons make a small incision within the eyebrow area to gain access to the underlying pathology, avoiding larger incisions and more extensive tissue disruption associated with traditional open craniotomies.
Conventional Frontal CraniotomyProcedure or surgery
The Conventional Frontal Craniotomy is a traditional surgical approach used to access and treat lesions located in the frontal region of the skull base. In this procedure, surgeons make a single or multiple large incisions in the scalp overlying the frontal bone to gain access to the underlying pathology.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Supraorbital Eyebrow Craniotomy | Experimental | his minimally invasive neurosurgical procedure accesses brain tumors by making a small incision within the eyebrow, providing access to pathologies of the anterior skull base. Compared to traditional frontal craniotomy, this approach aims to minimize tissue disruption, potentially reducing postoperative complications and improving cosmetic outcomes. The procedure involves precise surgical techniques guided by endoscopic visualization, allowing for targeted tumor resection while preserving surrounding healthy tissue. Additionally, the use of smaller incisions may lead to reduced scarring and faster recovery times compared to conventional approaches. Receives: Procedure: Endoscopic Supraorbital Eyebrow Craniotomy |
| Conventional Frontal Craniotomy | Active comparator | This arm represents the standard surgical approach for treating frontal skull base lesions. In this arm, surgeons perform the craniotomy through a conventional frontal approach rather than the endoscopic supraorbital eyebrow approach. This arm serves as the comparator against the experimental arm to evaluate the differences in cosmetic outcomes, scar assessment, and complications between the two surgical techniques. Receives: Procedure: Conventional Frontal Craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Cosmetic Outcomes in Frontal Craniotomy Approaches
Comparison between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy will be made.
The Scar Cosmesis and Assessment Rating (SCAR) scale will be used to determine the cosmetic outcome of the approach. The range of SCAR scale is 0 to 15. A score ≤ 5 on the SCAR scale will be considered cosmetic success. (Ziai et. al., 2022)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion2 Jan 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Model description
- The study employs a structured protocol involving random allocation to groups, preoperative assessments, surgery, postoperative follow-ups, and statistical analysis. It aims to evaluate differences in scar appearance, spread, erythema, suture marks, hypertrophy/atrophy, and overall impression between the two surgical approaches using the Scar Cosmesis Assessment Rating (SCAR) scale. Additionally, patient-reported outcomes such as itch and pain will be examined. This model ensures comprehensive evaluation of cosmetic outcomes and patient satisfaction, providing valuable insights to inform treatment regimens.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Ayesha Hashmi, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417658
- Sponsor's protocol ID
- Exp122
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cosmetic Results in Terms of Scar Assessment and Complications in Endoscopic Supraorbital Eyebrow Craniotomy vs Conventional Craniotomy for Frontal Skull Base Lesions
- ClinicalTrials.gov ID
- NCT06417658
- Acronym / sponsor ID
- Exp122
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 16 May 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 research study will compare the cosmetic outcomes, specifically scar assessment and complications, between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. The study will aim to evaluate the differences in scar appearance, spread, erythema, suture marks, hypertrophy/atrophy, and overall impression between the two approaches using the Scar Cosmesis Assessment Rating (SCAR) scale. Additionally, it will examine patient-reported outcomes such as itch and pain. The study will follow a structured protocol, including random allocation to groups, preoperative assessments, surgery, postoperative follow-ups, and statistical analysis. It will emphasize the importance of understanding cosmetic outcomes to improve patient satisfaction and inform treatment regimens.
Detailed description
The proposed research study will undertake a comparative analysis of the cosmetic outcomes associated with two distinct surgical approaches utilized in the treatment of frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy. This investigation will primarily focus on evaluating scar assessment and complications arising from these surgical procedures.
- Surgical Approaches: The study will compare two different techniques: the endoscopic supraorbital eyebrow craniotomy, which is a minimally invasive neurosurgical procedure involving a small incision within the eyebrow to access anterior skull base pathologies, and the conventional frontal craniotomy, a traditional approach involving a larger incision.
- Purpose: The primary objective will be to assess and compare the cosmetic outcomes, particularly scar appearance and related complications, between these two surgical methods. The emphasis will lie on evaluating parameters such as scar spread, erythema, suture marks, hypertrophy/atrophy, and overall impression using the Scar Cosmesis Assessment Rating (SCAR) scale.
- Study Protocol: Random Allocation: Patients will be randomly assigned to either the endoscopic supraorbital eyebrow craniotomy group or the conventional frontal craniotomy group. Preoperative Assessment: Comprehensive preoperative evaluations will be conducted to ascertain baseline data and ensure suitability for surgery. Surgery: Patients will undergo the assigned surgical procedure based on random allocation. Postoperative Follow-up: Close monitoring of patients post-surgery to assess scar healing and detect any complications. Data Collection: Data regarding scar assessment, complications, patient-reported outcomes, and other relevant parameters will be collected at specified intervals. Statistical Analysis: Rigorous statistical analysis of collected data will be conducted to draw comparisons and conclusions regarding cosmetic outcomes between the two surgical approaches.
- Patient-Reported Outcomes: In addition to clinician-assessed scar parameters, the study will also consider patient-reported outcomes such as itch and pain, providing a comprehensive understanding of the patient experience following these surgical interventions.
- Significance: The study will underscore the significance of evaluating cosmetic outcomes in neurosurgical procedures, aiming to enhance patient satisfaction and inform treatment decisions. By comparing the two surgical approaches, the research will seek to contribute valuable insights that may lead to the refinement of surgical techniques and improved patient care.
Overall, this proposed research endeavors to offer a detailed examination of the cosmetic results associated with endoscopic supraorbital eyebrow craniotomy versus conventional frontal craniotomy, thereby facilitating informed decision-making and optimizing patient outcomes in the management of frontal skull base lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study employs a structured protocol involving random allocation to groups, preoperative assessments, surgery, postoperative follow-ups, and statistical analysis. It aims to evaluate differences in scar appearance, spread, erythema, suture marks, hypertrophy/atrophy, and overall impression between the two surgical approaches using the Scar Cosmesis Assessment Rating (SCAR) scale. Additionally, patient-reported outcomes such as itch and pain will be examined. This model ensures comprehensive evaluation of cosmetic outcomes and patient satisfaction, providing valuable insights to inform treatment regimens.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Supraorbital Eyebrow Craniotomy | Experimental | Procedure: Endoscopic Supraorbital Eyebrow Craniotomyhis minimally invasive neurosurgical procedure accesses brain tumors by making a small incision within the eyebrow, providing access to pathologies of the anterior skull base. Compared to traditional frontal craniotomy, this approach aims to minimize tissue disruption, potentially reducing postoperative complications and improving cosmetic outcomes. The procedure involves precise surgical techniques guided by endoscopic visualization, allowing for targeted tumor resection while preserving surrounding healthy tissue. Additionally, the use of smaller incisions may lead to reduced scarring and faster recovery times compared to conventional approaches. |
| Conventional Frontal Craniotomy | Active comparator | Procedure: Conventional Frontal CraniotomyThis arm represents the standard surgical approach for treating frontal skull base lesions. In this arm, surgeons perform the craniotomy through a conventional frontal approach rather than the endoscopic supraorbital eyebrow approach. This arm serves as the comparator against the experimental arm to evaluate the differences in cosmetic outcomes, scar assessment, and complications between the two surgical techniques. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having frontal skull base lesion on MRI
- Lesion size <5cm on MRI with IV contrast
- Both male and female
- 25-65 years of age
Key exclusion criteria (7 listed)
- Patients with redo surgery (on medical record)
- Lesion size >5cm
- Vascular tumors
- Previous trauma
- Anticoagulant medications
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 Supraorbital Eyebrow CraniotomyThe Endoscopic Supraorbital Eyebrow Craniotomy is a minimally invasive neurosurgical procedure used to access and remove brain tumors located in the anterior skull base region. In this approach, surgeons make a small incision within the eyebrow area to gain access to the underlying pathology, avoiding larger incisions and more extensive tissue disruption associated with traditional open craniotomies. | Procedure or surgery | Endoscopic Supraorbital Eyebrow Craniotomy |
| Conventional Frontal CraniotomyThe Conventional Frontal Craniotomy is a traditional surgical approach used to access and treat lesions located in the frontal region of the skull base. In this procedure, surgeons make a single or multiple large incisions in the scalp overlying the frontal bone to gain access to the underlying pathology. | Procedure or surgery | Conventional Frontal Craniotomy |
Primary outcome
Comparing Cosmetic Outcomes in Frontal Craniotomy Approaches
Time frame: 12 months
Comparison between two surgical approaches for treating frontal skull base lesions: the endoscopic supraorbital eyebrow craniotomy and the conventional frontal craniotomy will be made. The Scar Cosmesis and Assessment Rating (SCAR) scale will be used to determine the cosmetic outcome of the approach. The range of SCAR scale is 0 to 15. A score ≤ 5 on the SCAR scale will be considered cosmetic success. (Ziai et. al., 2022)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Supraorbital Eyebrow Craniotomy and Conventional Frontal Craniotomy in people with Brain Tumor, run by University of Health Sciences Lahore.
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 4 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Comparing Cosmetic Outcomes in Frontal Craniotomy Approaches (time frame: 12 months). 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 16 May 2024.