Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis
Muscle Fascia for Skull Base Reconstruction in Sellar Region
Study Objective: The primary objective of this prospective randomized controlled study is
to evaluate and compare the effectiveness and safety of using fascia lata and temporal
muscle fascia for skull base reconstruction in the sellar region following endoscopic
endonasal surgery. The study aims to determine the level of donor site pain using Visual
Analogue Scales (VAS) and to identify the optimal reconstruction method with the lowest
complication rates.
Background: Tumors in the sellar region, such as pituitary adenomas, craniopharyngiomas,
meningiomas, and chordomas, present significant surgical challenges due to their
location. Advances in endoscopic techniques have improved surgical outcomes for these
tumors, but complications, particularly cerebrospinal fluid (CSF) leaks, remain common.
Reconstruction of skull base defects is critical to prevent CSF leaks and associated
infections. Autologous grafts, including fascia lata and temporal muscle fascia, are
commonly used for this purpose. This study seeks to compare these two graft materials in
terms of effectiveness, safety, and patient quality of life post-surgery.
Study Design:
Type: Prospective randomized controlled trial. Enrollment: 68 adult patients.
Randomization: Participants will be randomly assigned to one of two groups:
Group 1: Skull base reconstruction using fascia lata. Group 2: Skull base reconstruction
using temporal muscle fascia. Blinding: Single-blind (patients will not know which type
of fascia is used for their reconstruction).
Duration: The study will commence in August 2023 and is expected to last for 2-3 years.
Inclusion Criteria:
Adult patients (18 years and older) undergoing endoscopic endonasal surgery for sellar
region tumors.
Patients requiring reconstruction of the sellar floor to prevent postoperative CSF leaks.
Exclusion Criteria:
Pathology at the donor site (trauma, previous surgery). Absence of intraoperative CSF
leak. Use of alternative reconstruction materials. Prior radiation therapy to the
operative or donor site.
Interventions:
Group 1 (Fascia Lata): Grafts harvested from the thigh. Group 2 (Temporal Fascia): Grafts
harvested from the temporal muscle area. All surgeries will be performed by a
standardized surgical team comprising a neurosurgeon and an otolaryngologist. The
techniques for incision, hemostasis, and reconstruction will be consistent across all
procedures.
Outcome Measures:
Primary Outcome:
Donor site pain assessed using Visual Analogue Scales (VAS) at the following time points:
preoperative, postoperative days 1, 2, and 3, and at 1 and 3 months post-surgery.
Secondary Outcomes:
Incidence of postoperative complications such as meningitis, CSF leak, donor site
infection, wound dehiscence, seroma, facial nerve palsy, hypoesthesia of the donor site
skin, and diabetes insipidus (temporary or permanent).
Quality of life measured using the EQ-5D-5L questionnaire before surgery and at 1 and 3
months postoperatively.
Duration of surgical procedures. Length of hospital stay.
Statistical Analysis:
Power Analysis: A sample size of 34 participants per group is required to achieve 80%
power to detect a 30% difference in the incidence of mild versus moderate/severe pain
(VAS > 3.5), with a significance level of α = 0.05. Power analysis was conducted using
MedCalc® Statistical Software version 22.003.
Data Analysis: Normality of data distribution will be tested using histograms and the
Kolmogorov-Smirnov test. Continuous variables will be presented as mean (95% confidence
interval) or median (interquartile range), depending on distribution. Categorical
variables will be presented as absolute frequencies and percentages. Differences in
continuous variables between groups will be analyzed using one-way ANOVA with post-hoc
tests for parametric data or Kruskal-Wallis test with Dunn's post-hoc test for
non-parametric data. Differences in categorical variables will be analyzed using
Fisher-Freeman-Halton test for independent samples or McNemar's test for paired samples.
A significance level of p < 0.05 will be considered statistically significant. Data
analysis will be performed using IBM SPSS Statistics version 29.0.1.
Ethical Considerations:
The study has been approved by the Ethics Committee of KBC Zagreb. Informed consent will
be obtained from all participants prior to their inclusion in the study.
Participant privacy will be protected by anonymizing personal data and using unique coded
identifiers. Access to anonymized data will be strictly controlled, and any
de-anonymization will occur only under the supervision of the Ethics Committee.
Funding: The study is funded through clinical research funds dedicated to scientific
investigations at KBC Zagreb.
Expected Contributions: The study aims to provide empirical evidence on the comparative
effectiveness and safety of fascia lata versus temporal muscle fascia for skull base
reconstruction. Results will guide clinical decision-making, potentially reducing
perioperative morbidity, enhancing patient recovery, and improving quality of life
post-surgery.