Cervical Spine
Conditions
Brief summary
Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group
Detailed description
Dysphagia is a common complication after ACDF. PSTS is also a natural sequela of ACDF and can lead to airway compromise among other complications. Previous studies have demonstrated that administration of intravenous methylprednisolone (1mg/kg) after anterior cervical spine surgery reduced the incidence of pharyngolaryngeal lesions as identified by nasofibroscopic examination. Lee et al. prospectively evaluated 50 patients and determined that local application of steroids in the retropharyngeal area following ACDF reduced PSTS and odynophagia as measured by the Visual Analogue Scale (VAS) and the Neck Disability Index (NDI) compared to a control group. Furthermore, there were no adverse events/reactions from local application of steroid on a gel foam sponge in the setting of anterior spinal surgery. There are no studies in the current literature that investigate the incidence of dysphagia with application of local steroids after ACDF, nor are there any studies that stratify the efficacy of local steroids compared to intravenous steroids. There is also no current spine literature that directly compares the efficacy of intravenous steroids versus local steroids in the incidence of dysphagia or dysphonia. Our study will be the first in the literature to assess the efficacy of local steroids in reducing the incidence of dysphagia after anterior cervical spine surgery, and as a result, may improve patient outcomes after ACDF. Dysphagia and dysphonia are common complications after anterior cervical spine surgery. Despite their clinical importance, studies on the treatment and/or prevention of these complications are limited due to the lack of valid and reliable outcome measures. The majority of research is found in the otolaryngology literature and has focused on disease pathophysiology, diagnosis, and therapy. The Bazaz score has been used in the spine literature to evaluate dysphagia after anterior cervical discectomy and fusion (ACDF). This is a subjective questionnaire that has not been validated in the literature. Additionally, new patient-centered outcome measures, the Eating Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have recently been developed, and in addition to the Bazaz score, have been shown to have excellent validity and reliability in the ENT patient population. These instruments can be used to document the initial dysphagia or dysphonia severity and monitor the treatment response in people with a wide array of swallowing and voice disorders.
Interventions
DRUGDecadron
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
DRUGTriamcinolone
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing ACDF (single or multi-level) for the treatment of cervical radiculopathy or myelopathy * All subjects must have given signed, informed consent prior to registration on study.
Exclusion criteria
* Patients undergoing revision surgery, any operations for trauma, infection, tumor * Patients with general metabolic diseases such as rheumatoid arthritis, diabetes, chronic heart and renal diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 \>3 = dysphagia & EAT-10 \>15 = severe dysphagia |
| Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. | Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score \>11 |
| Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year | Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient. |
| Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op | Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient |
| Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group No steroid | 21 |
| IV Steroid 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate | 25 |
| Local Steroid 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate | 29 |
| Total | 75 |
Baseline characteristics
| Characteristic | Control Group | IV Steroid | Local Steroid | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 6 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 20 Participants | 23 Participants | 58 Participants |
| Age, Continuous | 54 years | 51.6 years | 55.6 years | 53.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 25 Participants | 29 Participants | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 25 Participants | 29 Participants | 75 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 21 participants | 25 participants | 29 participants | 75 participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 14 Participants | 35 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 15 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient
Time frame: Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op
Population: All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (1 yr. Post Op) | 4.0 Score on a scale |
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (1 Day Post Op) | 7.00 Score on a scale |
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (6 mo. Post Op) | 5.0 Score on a scale |
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (Baseline) | 8.0 Score on a scale |
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (2 wk. Post Op) | 6.00 Score on a scale |
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (6 wk. Post Op) | 5.00 Score on a scale |
| Control Group | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (3 mo. Post Op) | 4.5 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (Baseline) | 8.0 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (3 mo. Post Op) | 3.0 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (6 wk. Post Op) | 4.00 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (2 wk. Post Op) | 4.00 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (6 mo. Post Op) | 4.0 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (1 yr. Post Op) | 2.0 Score on a scale |
| IV Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (1 Day Post Op) | 6.00 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (1 yr. Post Op) | 1.0 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (Baseline) | 7.0 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (1 Day Post Op) | 6.00 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (2 wk. Post Op) | 4.00 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (6 wk. Post Op) | 5.00 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (3 mo. Post Op) | 3.00 Score on a scale |
| Local Steroid | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | VAS Pain Score (6 mo. Post Op) | 5.00 Score on a scale |
Primary
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient.
Time frame: Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year
Population: All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 3 mo. Post Op NDI | 14.6 percentage of disability/difficulty | Standard Deviation 40 |
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 2 wk. Post Op NDI | 31 percentage of disability/difficulty | Standard Deviation 20 |
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 6 wk. Post Op NDI | 23 percentage of disability/difficulty | Standard Deviation 19 |
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 1 yr. Post Op NDI | 22.2 percentage of disability/difficulty | Standard Deviation 33.6 |
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 6 mo. Post Op NDI | 23 percentage of disability/difficulty | Standard Deviation 19 |
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 1 Day Post Op NDI | 27 percentage of disability/difficulty | Standard Deviation 14 |
| Control Group | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | Baseline NDI | 40 percentage of disability/difficulty | Standard Deviation 19 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 2 wk. Post Op NDI | 24 percentage of disability/difficulty | Standard Deviation 15 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | Baseline NDI | 34 percentage of disability/difficulty | Standard Deviation 18 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 1 Day Post Op NDI | 28 percentage of disability/difficulty | Standard Deviation 16 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 6 wk. Post Op NDI | 21 percentage of disability/difficulty | Standard Deviation 15 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 3 mo. Post Op NDI | 11.1 percentage of disability/difficulty | Standard Deviation 23.3 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 6 mo. Post Op NDI | 21 percentage of disability/difficulty | Standard Deviation 15 |
| IV Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 1 yr. Post Op NDI | 4.0 percentage of disability/difficulty | Standard Deviation 18 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 3 mo. Post Op NDI | 10 percentage of disability/difficulty | Standard Deviation 23.5 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | Baseline NDI | 35 percentage of disability/difficulty | Standard Deviation 19 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 1 yr. Post Op NDI | 6.0 percentage of disability/difficulty | Standard Deviation 26 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 6 mo. Post Op NDI | 24 percentage of disability/difficulty | Standard Deviation 19 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 6 wk. Post Op NDI | 24 percentage of disability/difficulty | Standard Deviation 19 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 1 Day Post Op NDI | 27 percentage of disability/difficulty | Standard Deviation 18 |
| Local Steroid | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 2 wk. Post Op NDI | 20 percentage of disability/difficulty | Standard Deviation 16 |
Primary
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score \>11
Time frame: baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.
Population: All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Abnormal VHI-10 | 10.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Abnormal VHI-10 | 10.53 percentage of patients |
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Abnormal VHI-10 | 10.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Abnormal VHI-10 | 9.52 percentage of patients |
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Abnormal VHI-10 | 4.76 percentage of patients |
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | Baseline Abnormal VHI-10 | 9.52 percentage of patients |
| Control Group | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Abnormal VHI-10 | 10.53 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Abnormal VHI-10 | 8.33 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | Baseline Abnormal VHI-10 | 8.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Abnormal VHI-10 | 4.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Abnormal VHI-10 | 20.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Abnormal VHI-10 | 8.69 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Abnormal VHI-10 | 4.34 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Abnormal VHI-10 | 8.33 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Abnormal VHI-10 | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Abnormal VHI-10 | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Abnormal VHI-10 | 3.57 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Abnormal VHI-10 | 3.44 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | Baseline Abnormal VHI-10 | 3.44 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Abnormal VHI-10 | 3.44 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Abnormal VHI-10 | 0.00 percentage of patients |
Primary
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 \>3 = dysphagia & EAT-10 \>15 = severe dysphagia
Time frame: baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.
Population: All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Severe Dysphagia | 0.00 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Dysphagia | 38.09 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Severe Dysphagia | 38.09 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Severe Dysphagia | 10.52 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Severe Dysphagia | 20.00 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Dysphagia | 50.00 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Severe Dysphagia | 28.57 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Baseline Dysphagia | 9.52 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Dysphagia | 20.00 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Dysphagia | 21.05 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Baseline Severe Dysphagia | 0 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Dysphagia | 21.05 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Severe Dysphagia | 10.00 percentage |
| Control Group | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Dysphagia | 76.19 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Dysphagia | 0.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Severe Dysphagia | 0.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Baseline Dysphagia | 16.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Baseline Severe Dysphagia | 0 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Dysphagia | 68.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Severe Dysphagia | 32.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Dysphagia | 48.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Severe Dysphagia | 16.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Severe Dysphagia | 0.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Dysphagia | 8.69 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Severe Dysphagia | 0.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Dysphagia | 8.33 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Severe Dysphagia | 0.00 percentage |
| IV Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Dysphagia | 34.78 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Severe Dysphagia | 0.00 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Dysphagia | 6.89 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Dysphagia | 6.89 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Baseline Severe Dysphagia | 0 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 yr. Post Op Severe Dysphagia | 0.00 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 3 mo. Post Op Severe Dysphagia | 0.00 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Baseline Dysphagia | 10.34 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Dysphagia | 27.58 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Severe Dysphagia | 17.85 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Severe Dysphagia | 0.00 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 2 wk. Post Op Severe Dysphagia | 0.00 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 1 Day Post Op Dysphagia | 61.90 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 wk. Post Op Dysphagia | 17.24 percentage |
| Local Steroid | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 6 mo. Post Op Dysphagia | 13.79 percentage |
Primary
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
Outcome measure used to measure the incidence and severity of postoperative trouble swallowing
Time frame: Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year
Population: All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 mo. Post Op Bazaz Score (Mild or Greater) | 15.78 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 2 wk. Post Op Bazaz Score (Moderate-Severe) | 15.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 Day Post Op Bazaz Score (Mild or Greater) | 61.90 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 3 mo. Post Op Bazaz Score (Moderate-Severe) | 15.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 wk. Post Op Bazaz Score (Mild or Greater) | 28.57 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Baseline Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 3 mo. Post Op Bazaz Score (Mild or Greater) | 15.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 wk. Post Op Bazaz Score (Moderate-Severe) | 23.80 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 mo. Post Op Bazaz Score (Moderate-Severe) | 5.26 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 Day Post Op Bazaz Score (Moderate-Severe) | 33.33 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 yr. Post Op Bazaz Score (Moderate-Severe) | 5.26 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Baseline Bazaz Score (Mild or Greater) | 4.76 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 2 wk. Post Op Bazaz Score (Mild or Greater) | 30.00 percentage of patients |
| Control Group | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 yr. Post Op Bazaz Score (Mild or Greater) | 15.78 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 mo. Post Op Bazaz Score (Mild or Greater) | 8.33 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Baseline Bazaz Score (Mild or Greater) | 0.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Baseline Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 Day Post Op Bazaz Score (Mild or Greater) | 44.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 Day Post Op Bazaz Score (Moderate-Severe) | 24.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 2 wk. Post Op Bazaz Score (Mild or Greater) | 16.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 2 wk. Post Op Bazaz Score (Moderate-Severe) | 16.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 wk. Post Op Bazaz Score (Mild or Greater) | 17.39 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 wk. Post Op Bazaz Score (Moderate-Severe) | 8.69 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 3 mo. Post Op Bazaz Score (Mild or Greater) | 13.04 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 3 mo. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 mo. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 yr. Post Op Bazaz Score (Mild or Greater) | 0.00 percentage of patients |
| IV Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 yr. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 yr. Post Op Bazaz Score (Mild or Greater) | 3.44 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 3 mo. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 2 wk. Post Op Bazaz Score (Mild or Greater) | 13.79 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 Day Post Op Bazaz Score (Moderate-Severe) | 7.14 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 mo. Post Op Bazaz Score (Mild or Greater) | 13.79 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 Day Post Op Bazaz Score (Mild or Greater) | 50.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Baseline Bazaz Score (Mild or Greater) | 6.89 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 mo. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Baseline Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 wk. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 6 wk. Post Op Bazaz Score (Mild or Greater) | 6.89 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 1 yr. Post Op Bazaz Score (Moderate-Severe) | 3.44 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 3 mo. Post Op Bazaz Score (Mild or Greater) | 13.79 percentage of patients |
| Local Steroid | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | 2 wk. Post Op Bazaz Score (Moderate-Severe) | 0.00 percentage of patients |