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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \*\*Age\*\*: Adult patients (18 years and older).

• \*\*Surgical Requirement\*\*: Patients undergoing endoscopic endonasal surgery for sellar region tumors requiring reconstruction of the sellar floor to prevent postoperative cerebrospinal fluid (CSF) leaks.

• \*\*Consent\*\*: Patients who provide informed consent to participate in the study.

Locations
Other Locations
Croatia
KBC Zagreb
RECRUITING
Zagreb
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2033-12-01
Participants
Target number of participants: 68
Treatments
Active_comparator: Fascia lata
Participants in this group will undergo skull base reconstruction using fascia lata harvested from the thigh. The surgical team will perform endoscopic endonasal surgery to treat sellar region pathology and utilize fascia lata to repair the skull base defect. The procedure involves the extraction of the graft from the left thigh, followed by standard reconstruction techniques to ensure optimal healing and function of the skull base. Postoperative pain and other outcomes will be closely monitored and recorded using standardized measures.
Active_comparator: Temporal fascia
Participants in this group will undergo skull base reconstruction using temporal muscle fascia harvested from the temporal region of the head. The surgical team will perform endoscopic endonasal surgery to treat sellar region pathology and utilize temporal fascia to repair the skull base defect. The procedure involves the extraction of the graft from the left temporal region, followed by standard reconstruction techniques to ensure optimal healing and function of the skull base. Postoperative pain and other outcomes will be closely monitored and recorded using standardized measures.
Related Therapeutic Areas
Sponsors
Leads: Klinički Bolnički Centar Zagreb

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.