Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Comparing Cosmetic Outcomes Endoscopic vs Conventional Craniotomy for Frontal Skull Base Lesions
Sponsor:
University of Health Sciences Lahore
Organization:
University of Health Sciences Lahore
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The study will aim to evaluate the differences in scar appearance spread erythema suture marks hypertrophyatrophy 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
1 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
2 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 hypertrophyatrophy and overall impression using the Scar Cosmesis Assessment Rating SCAR scale
3 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
4 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
5 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
1 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
2 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 hypertrophyatrophy and overall impression using the Scar Cosmesis Assessment Rating SCAR scale
3 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
4 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
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None