Actively Recruiting
Comparing Fascia Lata and Temporal Muscle Fascia for Skull Base Reconstruction After Endoscopic Surgery in the Sellar Region
Led by Klinički Bolnički Centar Zagreb · Updated on 2024-07-11
68
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of using two types of tissue graftsfascia lata from the thigh and temporal muscle fascia from the headfor reconstructing the skull base in the sellar region after endoscopic endonasal surgery. This study aims to compare donor site pain levels and identify which graft method results in fewer complications, potentially reducing recovery time and improving patient outcomes. The trial is designed as a prospective randomized controlled study enrolling 68 adult patients. Participants will be randomly assigned to receive skull base reconstruction with either fascia lata harvested from the left thigh or temporal muscle fascia harvested from the left temporal region. Both groups will undergo standardized surgical procedures performed by a neurosurgeon and an otolaryngologist. The study follows patients for pain assessment and complication monitoring at multiple time points, including preoperative and up to three months after surgery. During the study, donor site pain will be measured using Visual Analogue Scales at preoperative baseline, postoperative days 1, 2, and 3, and at 1 and 3 months. Researchers will also monitor for complications such as meningitis, cerebrospinal fluid leaks, infections, wound issues, nerve effects, and diabetes insipidus. Quality of life will be assessed before surgery and at 1 and 3 months postoperatively. The trial includes detailed data analysis and patient privacy protections, with a total follow-up period of at least three months after surgery.
CONDITIONS
Brief Title
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
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