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

NCT06493812 | Recruiting

• 1 other identifier: 02/013 AG
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CSF; fascia lata; temporal fascia; quality of life; tissue transplantation

Outcome Measures

Primary Outcomes (1)

• Donor Site Pain

  The primary outcome measure is the level of donor site pain, assessed using Visual Analogue Scales (VAS). Visual Analog Scale (VAS) for Pain Minimum Value: 0 (No pain) Maximum Value: 10 (Worst pain imaginable) Outcome Interpretation Higher scores indicate worse outcomes (more intense pain). The VAS is a simple and widely used tool to help patients quantify their pain level. Patients mark their pain level on a 10 cm line that ranges from "no pain" to "worst pain imaginable."

  Preoperative, Postoperative Days 1, 2, and 3, and at 1 month and 3 months post-surgery.

Secondary Outcomes (2)

• Incidence of Postoperative Complications

  Up to 3 months post-surgery.

• Quality of life - EQ 5D

  Preoperative, 1 month post-surgery, and 3 months post-surgery.

Study Arms (2)

Fascia lata

ACTIVE COMPARATOR

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.

Procedure: Fascia lata

Temporal fascia

ACTIVE COMPARATOR

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.

Procedure: Temporal fascia

Interventions

Fascia lata PROCEDURE

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.

Fascia lata

Temporal fascia PROCEDURE

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.

Temporal fascia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*\*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.

You may not qualify if:

• \. \*\*Donor Site Pathology\*\*: Presence of pathology at the donor site, including trauma or previous surgical interventions.
• \. \*\*Absence of Intraoperative CSF Leak\*\*: Patients without an intraoperative CSF leak requiring reconstruction.
• \. \*\*Alternative Reconstruction Methods\*\*: Use of reconstruction materials other than fascia lata or temporal fascia.
• \. \*\*Prior Radiation Therapy\*\*: Patients who have received prior radiation therapy to the operative or donor site.
• \. \*\*Medical Contraindications\*\*: Patients with medical conditions that contraindicate the surgical procedure or participation in the study.

Sponsors & Collaborators

• Klinički Bolnički Centar Zagreb: lead

Study Sites (1)

KBC Zagreb

Zagreb, 10000, Croatia

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 10, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

CR (1)