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

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.

Conditions

• Skull Defect
• Transplant Complication
• Quality of Life

Interventions

PROCEDURE

Fascia lata

This intervention involves the harvesting of fascia lata from the thigh and its use in reconstructing the skull base defect following endoscopic endonasal surgery for sellar region pathology. The graft is extracted from the left thigh, and standard reconstruction techniques are employed to ensure optimal healing and functionality of the skull base. Postoperative monitoring includes assessments of donor site pain, incidence of complications, and overall recovery using standardized measures.

PROCEDURE

Temporal fascia

This intervention involves the harvesting of temporal muscle fascia from the temporal region of the head and its use in reconstructing the skull base defect following endoscopic endonasal surgery for sellar region pathology. The graft is extracted from the left temporal region, and standard reconstruction techniques are employed to ensure optimal healing and functionality of the skull base. Postoperative monitoring includes assessments of donor site pain, incidence of complications, and overall recovery using standardized measures.

Sponsors & Collaborators

• Klinički Bolnički Centar Zagreb

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2033-08-01

Completion

2033-12-01

Countries

• Croatia

Study Locations