Comparing Cosmetic Outcomes: Endoscopic vs. Conventional Craniotomy for Frontal Skull Base Lesions

NCT06417658 | Not Yet Recruiting

• 1 other identifier: Exp122
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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, 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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Study Arms (2)

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.

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.

Procedure: Conventional Frontal Craniotomy

Interventions

Endoscopic Supraorbital Eyebrow Craniotomy PROCEDURE

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.

Endoscopic Supraorbital Eyebrow Craniotomy

Conventional Frontal Craniotomy PROCEDURE

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.

Conventional Frontal Craniotomy

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having frontal skull base lesion on MRI
• Lesion size \<5cm on MRI with IV contrast
• Both male and female
• years of age

You may not qualify if:

• Patients with redo surgery (on medical record)
• Lesion size \>5cm
• Vascular tumors
• Previous trauma
• Anticoagulant medications
• Comorbidities(uncontrolled hypertension and diabetes)
• Skin diseases

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion: January 2, 2025
• Study Completion: February 2, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share