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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorUniversity of Puerto Rico

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The target population is female and male patients between 21 - 85 years old undergoing multilevel anterior cervical decompression and fusion.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Discectomy of Omohyoid

    Procedure/Surgery

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

  • Control group no discectomy of Omohyoid

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Discectomy of OmohyoidOther 1 intervention
Group B: No discectomy of OmohyoidOther 1 intervention

Trial outcomes

Primary outcomes

1

Neck Disability Index

This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.

Time frame
6 months
2

Dysphagia Short Questionnaire- "The Dysphagia Questionnaire

a 10-point rating scale, were 1 is the minimum value, 10 is the maximum value, and the higher scores means the worse outcome and lower scores are the better outcomes. In the Dysphagia questionnaire the patients provide an assessment of the severity of dysphagia symptoms experienced.

Time frame
6 months

Secondary outcomes

1

Neck Circumference

Measurement of neck circumference in centimeters

Time frame
Pre operation
2

Body Mass Index

Measure the body mass index of the patient

Time frame
Pre Operation

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: