## Protocol Section
### Identification Module
**NCT ID:** NCT06417658

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

**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

#### Organization Study ID Info
**ID:** Exp122
#### Organization
**Class:** OTHER
**Full Name:** University of Health Sciences Lahore
### Status Module
#### Completion Date
**Date:** 2025-02-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Health Sciences Lahore

#### Responsible Party

**Investigator Affiliation:** University of Health Sciences Lahore

**Investigator Full Name:** Syeda Ayesha Hashmi

**Investigator Title:** Post Graduate Resident

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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, 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.

### Conditions Module

**Conditions:**

- Brain Tumor

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 42

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Endoscopic Supraorbital Eyebrow Craniotomy

**Label:** Endoscopic Supraorbital Eyebrow Craniotomy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: Conventional Frontal Craniotomy

**Label:** Conventional Frontal Craniotomy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Endoscopic Supraorbital Eyebrow Craniotomy

**Description:** 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.

**Name:** Endoscopic Supraorbital Eyebrow Craniotomy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Conventional Frontal Craniotomy

**Description:** 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.

**Name:** Conventional Frontal Craniotomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Comparing Cosmetic Outcomes in Frontal Craniotomy Approaches

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients having frontal skull base lesion on MRI
2. Lesion size \<5cm on MRI with IV contrast
3. Both male and female
4. 25-65 years of age

Exclusion Criteria:

1. Patients with redo surgery (on medical record)
2. Lesion size \>5cm
3. Vascular tumors
4. Previous trauma
5. Anticoagulant medications
6. Comorbidities(uncontrolled hypertension and diabetes)
7. Skin diseases

**Maximum Age:** 65 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M5209

- Name: Brain Neoplasms

- Relevance: HIGH

- As Found: Brain Tumor

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001932

- Term: Brain Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
