Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493812
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-30
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
Sponsor:
Klinički Bolnički Centar Zagreb
Organization:
Klinički Bolnički Centar Zagreb
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
Randomization Participants will be randomly assigned to one of two groups
Group 1 Skull base reconstruction using fascia lata Group 2 Skull base reconstruction using temporal muscle fascia Blinding Single-blind patients will not know which type of fascia is used for their reconstruction
Duration The study will commence in August 2023 and is expected to last for 2-3 years
Inclusion Criteria
Adult patients 18 years and older undergoing endoscopic endonasal surgery for sellar region tumors
Patients requiring reconstruction of the sellar floor to prevent postoperative CSF leaks
Exclusion Criteria
Pathology at the donor site trauma previous surgery Absence of intraoperative CSF leak Use of alternative reconstruction materials Prior radiation therapy to the operative or donor site
Interventions
Group 1 Fascia Lata Grafts harvested from the thigh Group 2 Temporal Fascia Grafts harvested from the temporal muscle area All surgeries will be performed by a standardized surgical team comprising a neurosurgeon and an otolaryngologist The techniques for incision hemostasis and reconstruction will be consistent across all procedures
Outcome Measures
Primary Outcome
Donor site pain assessed using Visual Analogue Scales VAS at the following time points preoperative postoperative days 1 2 and 3 and at 1 and 3 months post-surgery
Secondary Outcomes
Incidence of postoperative complications such as meningitis CSF leak donor site infection wound dehiscence seroma facial nerve palsy hypoesthesia of the donor site skin and diabetes insipidus temporary or permanent
Quality of life measured using the EQ-5D-5L questionnaire before surgery and at 1 and 3 months postoperatively
Duration of surgical procedures Length of hospital stay
Statistical Analysis
Power Analysis A sample size of 34 participants per group is required to achieve 80 power to detect a 30 difference in the incidence of mild versus moderatesevere pain VAS 35 with a significance level of α 005 Power analysis was conducted using MedCalc Statistical Software version 22003
Data Analysis Normality of data distribution will be tested using histograms and the Kolmogorov-Smirnov test Continuous variables will be presented as mean 95 confidence interval or median interquartile range depending on distribution Categorical variables will be presented as absolute frequencies and percentages Differences in continuous variables between groups will be analyzed using one-way ANOVA with post-hoc tests for parametric data or Kruskal-Wallis test with Dunns post-hoc test for non-parametric data Differences in categorical variables will be analyzed using Fisher-Freeman-Halton test for independent samples or McNemars test for paired samples A significance level of p 005 will be considered statistically significant Data analysis will be performed using IBM SPSS Statistics version 2901
Ethical Considerations
The study has been approved by the Ethics Committee of KBC Zagreb Informed consent will be obtained from all participants prior to their inclusion in the study
Participant privacy will be protected by anonymizing personal data and using unique coded identifiers Access to anonymized data will be strictly controlled and any de-anonymization will occur only under the supervision of the Ethics Committee
Funding The study is funded through clinical research funds dedicated to scientific investigations at KBC Zagreb
Expected Contributions The study aims to provide empirical evidence on the comparative effectiveness and safety of fascia lata versus temporal muscle fascia for skull base reconstruction Results will guide clinical decision-making potentially reducing perioperative morbidity enhancing patient recovery and improving quality of life post-surgery
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
Randomization Participants will be randomly assigned to one of two groups
Group 1 Skull base reconstruction using fascia lata Group 2 Skull base reconstruction using temporal muscle fascia Blinding Single-blind patients will not know which type of fascia is used for their reconstruction
Duration The study will commence in August 2023 and is expected to last for 2-3 years
Inclusion Criteria
Adult patients 18 years and older undergoing endoscopic endonasal surgery for sellar region tumors
Patients requiring reconstruction of the sellar floor to prevent postoperative CSF leaks
Exclusion Criteria
Pathology at the donor site trauma previous surgery Absence of intraoperative CSF leak Use of alternative reconstruction materials Prior radiation therapy to the operative or donor site
Interventions
Group 1 Fascia Lata Grafts harvested from the thigh Group 2 Temporal Fascia Grafts harvested from the temporal muscle area All surgeries will be performed by a standardized surgical team comprising a neurosurgeon and an otolaryngologist The techniques for incision hemostasis and reconstruction will be consistent across all procedures
Outcome Measures
Primary Outcome
Donor site pain assessed using Visual Analogue Scales VAS at the following time points preoperative postoperative days 1 2 and 3 and at 1 and 3 months post-surgery
Secondary Outcomes
Incidence of postoperative complications such as meningitis CSF leak donor site infection wound dehiscence seroma facial nerve palsy hypoesthesia of the donor site skin and diabetes insipidus temporary or permanent
Quality of life measured using the EQ-5D-5L questionnaire before surgery and at 1 and 3 months postoperatively
Duration of surgical procedures Length of hospital stay
Statistical Analysis
Power Analysis A sample size of 34 participants per group is required to achieve 80 power to detect a 30 difference in the incidence of mild versus moderatesevere pain VAS 35 with a significance level of α 005 Power analysis was conducted using MedCalc Statistical Software version 22003
Data Analysis Normality of data distribution will be tested using histograms and the Kolmogorov-Smirnov test Continuous variables will be presented as mean 95 confidence interval or median interquartile range depending on distribution Categorical variables will be presented as absolute frequencies and percentages Differences in continuous variables between groups will be analyzed using one-way ANOVA with post-hoc tests for parametric data or Kruskal-Wallis test with Dunns post-hoc test for non-parametric data Differences in categorical variables will be analyzed using Fisher-Freeman-Halton test for independent samples or McNemars test for paired samples A significance level of p 005 will be considered statistically significant Data analysis will be performed using IBM SPSS Statistics version 2901
Ethical Considerations
The study has been approved by the Ethics Committee of KBC Zagreb Informed consent will be obtained from all participants prior to their inclusion in the study
Participant privacy will be protected by anonymizing personal data and using unique coded identifiers Access to anonymized data will be strictly controlled and any de-anonymization will occur only under the supervision of the Ethics Committee
Funding The study is funded through clinical research funds dedicated to scientific investigations at KBC Zagreb
Expected Contributions The study aims to provide empirical evidence on the comparative effectiveness and safety of fascia lata versus temporal muscle fascia for skull base reconstruction Results will guide clinical decision-making potentially reducing perioperative morbidity enhancing patient recovery and improving quality of life post-surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None