Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-25
Brief Title:
The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients
Sponsor:
University of Puerto Rico
Organization:
University of Puerto Rico
Study Overview
Official Title:
The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients Undergoing Multilevel Anterior Cervical Discectomy and Fusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The investigators believe that the transection of the omohyoid during an anterior cervical discectomy and fusion decreases the incidence of dysphagia in patients who undergo this procedure when compared to patients who do not have the omohyoid transected
Detailed Description:
Dysphagia is a common postoperative complication in patients undergoing anterior cervical discectomy and fusion ACDF Although it is often transient there have been cases of postoperative dysphagia lasting for several months or being permanent The pathogenesis of this complication is poorly understood and likely multifactorial There have been multiple risk factors described that may contribute to postoperative dysphagia but there is a lack of clarity regarding these The effect of transecting the omohyoid during a multilevel Anterior Cervical Discectomy and Fusion has been controversial The transaction of this muscle is generally safe and is often used during the approach of the technique for improved visualization
This research study aims to determine whether the transection of the omohyoid affects the incidence of dysphagia in patients who underwent multilevel ACDF and whether it should be routinely performed during a multilevel ACDF The investigators plan to prospectively enroll 60 patients undergoing multilevel ACDF C3-C7 Patients selected in the allotted time frame were treated by the orthopedic spine service of the University of Puerto Rico Orthopaedic Surgery Residency Program Exclusion criteria include those patients with preoperative dysphagia those with conditions that expose them to a high risk of postoperative dysphagia such as motor neuron disease and those with cervical non-degenerative pathology such as tumor or trauma Randomization was performed utilizing an online computer-generated sequence wwwgraphpadcomquickcalcsrandomN1cfm A request for the waiver of authorization to release health information will be completed After the research committee approves medical records will be reviewed to gather information such as age gender smoking status diabetic status body mass index BMI inpatient medications and discharge medications After discharge patients undergoing this procedure are followed up at outpatient clinics Clinicas Externas Follow-up intervals include postoperative days 1 and 2 4 and 8 weeks after surgical intervention On the first postoperative day and each of the follow-up visits we will collect dysphagia scores via a modified Swallowing Quality of Life Scale Swal-QOL and physician notes Physician notes will also be evaluated for clear documentation of patient-reported outcomes Results will be gathered to evaluate outcomes and complications
The target population is female and male patients between 21 - 85 years old undergoing multilevel anterior cervical decompression and fusion
Patients with a history of preoperative dysphagia those with conditions that expose them to high risk of postoperative dysphagia such as motor neuron disease and those with cervical non-degenerative pathology such as tumor or trauma as well as those who have lost to follow up will be excluded from the study
The risks of participating in this study though minimal include a breach in confidentiality The benefits of participation include contributing to the Orthopaedic Surgery research community to guide future pain management in fracture care
To ensure the confidentiality of subjects data all information gathered from medical records MR will be de-identified and stored in a password-protected database The database will only be accessible to Principal Investigators CO-Principal Investigators and students from the Orthopaedic Surgery Department who meet all CITI Program requirements and have completed HIPAA training An identification number will be assigned to each participant to not use the patients number from the Medical Record Data for age gender smoking status diabetic status body mass index BMI inpatient medications and discharge medications will be collected apart from Medical Record numbers and identifiable data These documents can only be accessed by those electronically permitted by the Principal Investigator furthermore a unique password has to be written to access the database Therefore since there are different measures to ensure privacy electronic permit granted by Principal Investigator and password protection we understand that this research ensures adequate parameters for confidentiality After data collection and statistical analysis are done the password-protected database will be made inaccessible deleted and destroyed to preclude reproduction and divulgation of data Identifiers will not be maintained following the completion of the study The study is composed of patients who underwent Principal Investigators at our institutions The sub-groups will be created based on the transaction of omohyoid transected vs non-transected to allow comparisons in Sociodemographic information past medical history body mass index and confounding variables that might affect our results are patient comorbidities gender and levels of fused Finally the population selected may represent convenience bias due to its location on the northeast side of Puerto Rico
This research study aims to determine whether the transection of the omohyoid affects the incidence of dysphagia in patients who underwent multilevel ACDF and whether it should be routinely performed during a multilevel ACDF The investigators plan to prospectively enroll 60 patients undergoing multilevel ACDF C3-C7 Patients selected in the allotted time frame were treated by the orthopedic spine service of the University of Puerto Rico Orthopaedic Surgery Residency Program Exclusion criteria include those patients with preoperative dysphagia those with conditions that expose them to a high risk of postoperative dysphagia such as motor neuron disease and those with cervical non-degenerative pathology such as tumor or trauma Randomization was performed utilizing an online computer-generated sequence wwwgraphpadcomquickcalcsrandomN1cfm A request for the waiver of authorization to release health information will be completed After the research committee approves medical records will be reviewed to gather information such as age gender smoking status diabetic status body mass index BMI inpatient medications and discharge medications After discharge patients undergoing this procedure are followed up at outpatient clinics Clinicas Externas Follow-up intervals include postoperative days 1 and 2 4 and 8 weeks after surgical intervention On the first postoperative day and each of the follow-up visits we will collect dysphagia scores via a modified Swallowing Quality of Life Scale Swal-QOL and physician notes Physician notes will also be evaluated for clear documentation of patient-reported outcomes Results will be gathered to evaluate outcomes and complications
The target population is female and male patients between 21 - 85 years old undergoing multilevel anterior cervical decompression and fusion
Patients with a history of preoperative dysphagia those with conditions that expose them to high risk of postoperative dysphagia such as motor neuron disease and those with cervical non-degenerative pathology such as tumor or trauma as well as those who have lost to follow up will be excluded from the study
The risks of participating in this study though minimal include a breach in confidentiality The benefits of participation include contributing to the Orthopaedic Surgery research community to guide future pain management in fracture care
To ensure the confidentiality of subjects data all information gathered from medical records MR will be de-identified and stored in a password-protected database The database will only be accessible to Principal Investigators CO-Principal Investigators and students from the Orthopaedic Surgery Department who meet all CITI Program requirements and have completed HIPAA training An identification number will be assigned to each participant to not use the patients number from the Medical Record Data for age gender smoking status diabetic status body mass index BMI inpatient medications and discharge medications will be collected apart from Medical Record numbers and identifiable data These documents can only be accessed by those electronically permitted by the Principal Investigator furthermore a unique password has to be written to access the database Therefore since there are different measures to ensure privacy electronic permit granted by Principal Investigator and password protection we understand that this research ensures adequate parameters for confidentiality After data collection and statistical analysis are done the password-protected database will be made inaccessible deleted and destroyed to preclude reproduction and divulgation of data Identifiers will not be maintained following the completion of the study The study is composed of patients who underwent Principal Investigators at our institutions The sub-groups will be created based on the transaction of omohyoid transected vs non-transected to allow comparisons in Sociodemographic information past medical history body mass index and confounding variables that might affect our results are patient comorbidities gender and levels of fused Finally the population selected may represent convenience bias due to its location on the northeast side of Puerto Rico
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