[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skull-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skull-defect":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100471270","prospective-observational-study-on-comprehensive-effects-of-peek-cranioplasty-and-titanium-cranioplasty-after-dcrecept-dc-100471270",false,"NCT05416684","Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）","A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy","Inclusion Criteria:\n\n* Skull defect with a diameter greater than 3cm\n* No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation\n* Cranioplasty is feasible according to doctor's evaluation\n* Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.\n\nExclusion Criteria:\n\n* Manifestations of intracranial hypertension or untreated hydrocephalus\n* Poor healing of skin wound\n* Intracerebral infection or intracerebral hematoma is not cured\n* Patients with operational contradictions, for example, poor general condition","ALL","18 Years","65 Years",{"count":20,"type":21},358,"ESTIMATED","OBSERVATIONAL","The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.",[25],"Skull Defect",[25,27,28],"Epilepsy","Infections","RECRUITING","2024-11-07",{"date":32,"type":33},"2024-11-12","ACTUAL",{"date":30,"type":21},{"date":36,"type":21},"2027-09-30",{"name":38,"class":39},"RenJi Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100554032","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-100554032","NCT06493812","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","Inclusion Criteria:\n\n1. \\*\\*Age\\*\\*: Adult patients (18 years and older).\n2. \\*\\*Surgical Requirement\\*\\*: Patients undergoing endoscopic endonasal surgery for sellar region tumors requiring reconstruction of the sellar floor to prevent postoperative cerebrospinal fluid (CSF) leaks.\n3. \\*\\*Consent\\*\\*: Patients who provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* 1\\. \\*\\*Donor Site Pathology\\*\\*: Presence of pathology at the donor site, including trauma or previous surgical interventions.\n\n  2\\. \\*\\*Absence of Intraoperative CSF Leak\\*\\*: Patients without an intraoperative CSF leak requiring reconstruction.\n\n  3\\. \\*\\*Alternative Reconstruction Methods\\*\\*: Use of reconstruction materials other than fascia lata or temporal fascia.\n\n  4\\. \\*\\*Prior Radiation Therapy\\*\\*: Patients who have received prior radiation therapy to the operative or donor site.\n\n  5\\. \\*\\*Medical Contraindications\\*\\*: Patients with medical conditions that contraindicate the surgical procedure or participation in the study.",{"count":48,"type":21},68,"INTERVENTIONAL",[51],"NA","Study Title: Assessing the Clinical Significance of Using Fascia Lata versus Temporalis Muscle Fascia for Skull Base Reconstruction in Sellar Region\n\nObjective: 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.\n\nSubjects and Methods:\n\nStudy 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.\n\nInterventions: 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.\n\nMeasurements:\n\nPrimary 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).\n\nSecondary Outcomes: Incidence of postoperative complications such as meningitis, cerebrospinal fluid (CSF) leak, donor site infection, and other surgical complications.\n\nExpected 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.",[25,54,55],"Transplant Complication","Quality of Life",[57,58,59,60,61],"CSF","fascia lata","temporal fascia","quality of life","tissue transplantation","2024-07-09",{"date":64,"type":33},"2024-07-11",{"date":66,"type":33},"2023-06-01",{"date":68,"type":21},"2033-12-01",{"name":70,"class":39},"Klinički Bolnički Centar Zagreb"]