Comparison of Clinical Value in the Use of the Fascia Lata and Temporal Muscle Fascia in the Reconstruction of the Dura in the Sellar Region
NCT Number: NCT06493812
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skull Defect|Transplant Complication|Quality of Life
Interventions: PROCEDURE: Fascia lata|PROCEDURE: Temporal fascia
Sponsor: Klinički Bolnički Centar Zagreb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2033-12-01
Locations: KBC Zagreb, Zagreb, 10000, Croatia

Summary:
Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis Muscle Fascia for Skull Base Reconstruction in Sellar Region

Objective: The primary objective of this study is to investigate and compare the effectiveness and safety of using fascia lata and temporal muscle fascia in the reconstruction of the skull base in the sellar region. Specifically, the study aims to determine and compare the level of donor site pain between the two groups using Visual Analogue Scales (VAS). The study also aims to identify the optimal method and materials for skull base reconstruction that result in the lowest frequency of complications, thereby reducing perioperative morbidity and enabling earlier rehabilitation of patients.

Subjects and Methods:

Study Design: Prospective randomized controlled trial. Population: The study will enroll 68 patients who have undergone endoscopic endonasal surgery for sellar region pathology. Patients will be divided into two groups: one group will receive skull base reconstruction using fascia lata, and the other group will receive reconstruction using temporal fascia.

Interventions: In the fascia lata group, grafts will be harvested from the thigh, while in the temporal fascia group, grafts will be harvested from the temporal muscle area.

Measurements:

Primary Outcome: Donor site pain measured using Visual Analogue Scales (VAS) at various postoperative intervals (preoperative, and on the 1st, 2nd, and 3rd postoperative days, as well as 1 month and 3 months post-surgery).

Secondary Outcomes: Incidence of postoperative complications such as meningitis, cerebrospinal fluid (CSF) leak, donor site infection, and other surgical complications.

Expected Contribution: This research is expected to provide valuable insights into the comparative effectiveness and safety of using fascia lata versus temporal muscle fascia for skull base reconstruction. The findings could influence clinical decisions regarding the choice of graft material, potentially leading to reduced perioperative morbidity, faster patient rehabilitation, and improved overall outcomes for patients undergoing skull base surgeries.

Primary Outcome Measures: Donor Site Pain, The primary outcome measure is the level of donor site pain, assessed using Visual Analogue Scales (VAS).

Visual Analog Scale (VAS) for Pain

Minimum Value: 0 (No pain) Maximum Value: 10 (Worst pain imaginable)

Outcome Interpretation Higher scores indicate worse outcomes (more intense pain).

The VAS is a simple and widely used tool to help patients quantify their pain level. Patients mark their pain level on a 10 cm line that ranges from "no pain" to "worst pain imaginable.", Preoperative, Postoperative Days 1, 2, and 3, and at 1 month and 3 months post-surgery.
Secondary Outcome Measures: Incidence of Postoperative Complications, The frequency of complications following the surgical procedures, including:

* Meningitis
* Postoperative cerebrospinal fluid (CSF) leak
* Donor site wound dehiscence
* Donor site infection
* Seroma formation at the donor site
* Facial nerve palsy
* Hypoesthesia of the donor site skin
* Diabetes insipidus (temporary or permanent), Up to 3 months post-surgery.|Quality of life - EQ 5D, Assessment of the patients' quality of life using the EQ-5D-5L questionnaire.

* \*\*Minimum Value\*\*: The EQ-5D-5L generates a descriptive profile and a single index value. For the descriptive profile, each of the 5 dimensions has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The single index value ranges from -0.281 (theoretical minimum, country-specific) to 1 (perfect health).
* \*\*Outcome Interpretation\*\*: Higher scores on the descriptive profile indicate worse health states. For the single index value, higher scores indicate better health outcomes.

The EQ-5D-5L is used to assess the general health status of a patient across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity, and the responses can be combined into a single index value representing overall health status., Preoperative, 1 month post-surgery, and 3 months post-surgery.