Actively Recruiting
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
Led by Klinički Bolnički Centar Zagreb · Updated on 2024-07-11
68
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of using two types of tissue grafts—fascia lata from the thigh and temporal muscle fascia from the head—for 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years and older
- Undergoing endoscopic endonasal surgery for sellar region tumors
- Require reconstruction of the sellar floor to prevent postoperative cerebrospinal fluid leaks
- Provide informed consent to participate in the study
You will not qualify if you...
- Presence of pathology at the donor site such as trauma or previous surgery
- No intraoperative cerebrospinal fluid leak requiring reconstruction
- Use of reconstruction materials other than fascia lata or temporal fascia
- Prior radiation therapy to the surgery or donor site area
- Medical conditions that prevent surgery or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo endoscopic endonasal surgery for sellar region tumors, including reconstruction of the skull base using either fascia lata or temporal muscle fascia.
1 surgical procedure visit (in-person)
Duration - 3 months
Participants are monitored for donor site pain, postoperative complications, and quality of life. Pain assessments occur on postoperative days 1, 2, and 3, and at 1 and 3 months post-surgery. Quality of life and complication assessments also occur at 1 and 3 months post-surgery.
6 visits (in-person) including assessments on days 1, 2, 3, 1 month, and 3 months post-surgery
Trial Site Locations
Total: 1 location
1
KBC Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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