- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06482632
The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients
The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients Undergoing Multilevel Anterior Cervical Discectomy and Fusion
Study Overview
Status
Conditions
Intervention / Treatment
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. We 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 (www.graphpad.com/quickcalcs/randomN1.cfm). 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 patient's 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carlos Guevara-Serra, MD
- Phone Number: 2104 7877773535
- Email: carlos.guevara2@upr.edu
Study Locations
-
-
-
San Juan, Puerto Rico, 00935
- Hospital Oncológico Dr. Isaac González Martínez
-
Contact:
- Carlos Guevara-Serra, MD
- Phone Number: 2107 7877773535
- Email: carlos.guevara2@upr.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The target population is female and male patients between 21 - 85 years old undergoing multilevel anterior cervical decompression and fusion.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Discectomy of Omohyoid
Patient undergoing an anterior cervical discectomy (ACDF) and fusion will have the Omohyoid removed to determine the effect of dysphagia after surgery.
|
Will be removing the Omohyoid during an anterior cervical discectomy and fusion to compare its effect of dysphagia.
|
Other: No discectomy of Omohyoid
Patient undergoing an anterior cervical discectomy (ACDF) and fusion will not have the Omohyoid removed to determine the effect of dysphagia after surgery.
|
Will not be removing the Omohyoid during an anterior cervical discectomy and fusion to compare its effect of dysphagia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: 6 months
|
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
|
6 months
|
Dysphagia Short Questionnaire
Time Frame: 6 months
|
a 10-point rating scale where patients provide an assessment of the severity of dysphagia symptoms experienced.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Circumference
Time Frame: Pre operation
|
Measurement of neck circumference in centimeters
|
Pre operation
|
Body Mass Index
Time Frame: Pre Operation
|
Measure the body mass index of the patient
|
Pre Operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 119384
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cervical Pain
-
University of PittsburghNot yet recruitingAnterior Cervical Discectomy and FusionUnited States
-
National Taiwan University HospitalUnknownPatients Receiving Anterior Cervical Spine Surgery
-
University of ArkansasCompletedAnterior Cervical Discectomy and Fusion (ACDF)United States
-
Gangnam Severance HospitalCompletedAnterior Cervical Discectomy and Fusion (ACDF) SurgeryKorea, Republic of
-
Universiti Kebangsaan Malaysia Medical CentreNot yet recruitingAnterior Spinal Artery Compression Syndromes, Cervical RegionMalaysia
-
Chinese University of Hong KongRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Patellofemoral PainHong Kong
-
University of DeustoUniversity of the Basque Country (UPV/EHU); Osakidetza; Matia FoundationRecruitingCervical Pain | Cervical Radiculopathy | Cervical Radicular PainSpain
-
Palo Alto Veterans Institute for ResearchAllerganCompletedSubacute Cervical Pain | Subacute Upper Back Pain
-
Afyonkarahisar Health Sciences UniversityCompletedMusculoskeletal Diseases | Cervical Pain | Radiculopathy | Cervical Disc Disease | Cervical Radicular PainTurkey
-
Ahram Canadian UniversityRecruiting
Clinical Trials on Discectomy of Omohyoid
-
Sun Yat-sen UniversityUnknown
-
Quanta MedicalCousin BiotechRecruitingDisk Herniated LumbarFrance
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Sun Yat-Sen Memorial Hospital...UnknownOral Squamous Cell CarcinomaChina
-
Anulex Technologies, Inc.Completed
-
Third Affiliated Hospital, Sun Yat-Sen UniversityActive, not recruiting
-
Intrinsic TherapeuticsActive, not recruitingLumbar Spine Disc HerniationUnited States
-
Saglik Bilimleri UniversitesiCompletedDisplacement of Intervertebral Disc Without MyelopathyTurkey
-
Southeast University, ChinaUnknownLumbar Disc Herniation
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRecruiting
-
Valérie SchuermansRecruitingCervical Disc Disease | Cervical Fusion | Fusion of Spine | Cervical Spondylosis | Cervical Disc Herniation | Myelopathy Cervical | Cervical Disc Degeneration | Radiculopathy, Cervical | Myelopathy, Compressive | Radiculopathy, Cervical Region | Radiculopathy; in Spondylosis | Radiculopathy; in Intervertebral... and other conditionsNetherlands