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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Donor Site Pain
研究概览
简要总结
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.
详细描述
Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis Muscle Fascia for Skull Base Reconstruction in Sellar Region
Study Objective: The primary objective of this prospective randomized controlled study is to evaluate and compare the effectiveness and safety of using fascia lata and temporal muscle fascia for skull base reconstruction in the sellar region following endoscopic endonasal surgery. The study aims to determine the level of donor site pain using Visual Analogue Scales (VAS) and to identify the optimal reconstruction method with the lowest complication rates.
Background: Tumors in the sellar region, such as pituitary adenomas, craniopharyngiomas, meningiomas, and chordomas, present significant surgical challenges due to their location. Advances in endoscopic techniques have improved surgical outcomes for these tumors, but complications, particularly cerebrospinal fluid (CSF) leaks, remain common. Reconstruction of skull base defects is critical to prevent CSF leaks and associated infections. Autologous grafts, including fascia lata and temporal muscle fascia, are commonly used for this purpose. This study seeks to compare these two graft materials in terms of effectiveness, safety, and patient quality of life post-surgery.
Study Design:
Type: Prospective randomized controlled trial. Enrollment: 68 adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**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.
排除标准
- •1. **Donor Site Pathology**: Presence of pathology at the donor site, including trauma or previous surgical interventions.
- •2. **Absence of Intraoperative CSF Leak**: Patients without an intraoperative CSF leak requiring reconstruction.
- •3. **Alternative Reconstruction Methods**: Use of reconstruction materials other than fascia lata or temporal fascia.
- •4. **Prior Radiation Therapy**: Patients who have received prior radiation therapy to the operative or donor site.
- •5. **Medical Contraindications**: Patients with medical conditions that contraindicate the surgical procedure or participation in the study.
结局指标
主要结局
Donor Site Pain
时间窗: Preoperative, Postoperative Days 1, 2, and 3, and at 1 month and 3 months post-surgery.
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."
次要结局
- 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.)
研究者
Marcel Marjanovic Kavanagh
Principal investigator
Klinički Bolnički Centar Zagreb