Possibia

6417658

Last Update Posted: 2024-05-16

Recruiting has not begun

All Genders

accepted

25 Years-65 Years

42 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

Comparing Cosmetic Outcomes: Endoscopic 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.

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, hypertrophy/atrophy, 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.

Eligibility

Relevant conditions:

Brain Tumor

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Contact Information

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Data sourced from ClinicalTrials.gov