The Effect of the Transection of the Omohyoid in the Incidence of Dysphagia in Patients

NCT ID: NCT06482632

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-05-29

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 (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.

Conditions

Anterior Cervical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Discectomy of Omohyoid

Intervention Type: PROCEDURE

Will be removing the Omohyoid during an anterior cervical discectomy and fusion to compare its effect of dysphagia.

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.

Group Type: OTHER

Control group no discectomy of Omohyoid

Intervention Type: PROCEDURE

Will not be removing the Omohyoid during an anterior cervical discectomy and fusion to compare its effect of dysphagia.

Interventions

Discectomy of Omohyoid

Will be removing the Omohyoid during an anterior cervical discectomy and fusion to compare its effect of dysphagia.

Intervention Type: PROCEDURE

Control group no discectomy of Omohyoid

Will not be removing the Omohyoid during an anterior cervical discectomy and fusion to compare its effect of dysphagia.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Oncológico Dr. Isaac González Martínez

San Juan, , Puerto Rico

Countries

Puerto Rico

Central Contacts

Carlos Guevara-Serra, MD

Role: CONTACT

carlos.guevara2@upr.edu

7877773535 ext. 2104

Facility Contacts

Carlos Guevara-Serra, MD

Role: primary

carlos.guevara2@upr.edu

7877773535 ext. 2107

Other Identifiers

119384

Identifier Type: -

Identifier Source: org_study_id