Cervical SpineNCT02577991

Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)

A study testing Decadron and Triamcinolone in people with Cervical Spine, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Cervical Spine
What is being tested?: Decadron and Triamcinolone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Medicine Department of Orthopaedic Surgery
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Prospective, Randomized Controlled Trial on the Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)

Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group

Read the 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.

Conditions: Cervical Spine
Being tested: Decadron, Triamcinolone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DecadronDrug
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
TriamcinoloneDrug
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Study groups in NCT02577991
Study group	Role	What they receive
Control group	No intervention	No steroid
IV steroid	Experimental	10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate Receives: Drug: Decadron
Local steroid	Experimental	40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate Receives: Drug: Triamcinolone

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
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
Measured: 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.
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.
Measured: 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
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
Measured: 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
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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jun 2017

First posted16 Oct 2015 (estimated)
Study startFeb 2014
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Cervical SpineStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02577991
Sponsor's protocol ID: STU00085674
Status last verified: May 2019
First submitted: 12 Oct 2015
Last updated: 30 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
PubMed 17906571
Sanfilippo JA Jr, Lim MR, Jacoby SM, Laterra R, Harrop JS, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. "Normal" prevertebral soft tissue swelling following elective anterior cervical decompression and fusion. J Spinal Disord Tech. 2006 Aug;19(6):399-401. doi: 10.1097/00024720-200608000-00004.
PubMed 16891973
Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4.
PubMed 12592551
Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.
PubMed 22020609
McAfee PC, Cappuccino A, Cunningham BW, Devine JG, Phillips FM, Regan JJ, Albert TJ, Ahrens JE. Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal Disord Tech. 2010 Feb;23(1):1-8. doi: 10.1097/BSD.0b013e31819e2ab8.
PubMed 20051917
Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
PubMed 19140539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cervical Spine trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized Controlled Trial on the Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
ClinicalTrials.gov ID: NCT02577991
Acronym / sponsor ID: STU00085674
Conditions: Cervical Spine
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Feb 2014 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 16 Oct 2015 (estimated)
Results: Posted 30 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–No steroid
IV steroid	Experimental	Drug: Decadron10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Local steroid	Experimental	Drug: Triamcinolone40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Decadron10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate	Drug	IV steroid
Triamcinolone40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate	Drug	Local steroid

Primary outcome

Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
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.
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
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.
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
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
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
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
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
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
Outcome measure used to measure the incidence and severity of postoperative trouble swallowing

Results and safety

Results posted to the registry on 30 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	24	21
IV Steroid	27	25
Local Steroid	29	29

Primary outcome: Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op

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.. Number. Unit: percentage

Measure	Control Group n = 21	IV Steroid n = 25	Local Steroid n = 29
Baseline Dysphagia	9.52	16.00	10.34
Baseline Severe Dysphagia	0	0	0
1 Day Post Op Dysphagia	76.19	68.00	61.90
1 Day Post Op Severe Dysphagia	38.09	32.00	17.85
2 wk. Post Op Dysphagia	50.00	48.00	27.58
2 wk. Post Op Severe Dysphagia	20.00	16.00	0.00
6 wk. Post Op Dysphagia	38.09	34.78	17.24
6 wk. Post Op Severe Dysphagia	28.57	0.00	0.00

Population analysed: 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

Primary outcome: Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op

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.. Number. Unit: percentage of patients

Measure	Control Group n = 21	IV Steroid n = 25	Local Steroid n = 29
Baseline Abnormal VHI-10	9.52	8.00	3.44
1 Day Post Op Abnormal VHI-10	4.76	4.00	3.57
2 wk. Post Op Abnormal VHI-10	10.00	20.00	0.00
6 wk. Post Op Abnormal VHI-10	9.52	8.69	3.44
3 mo. Post Op Abnormal VHI-10	10.00	4.34	0.00
6 mo. Post Op Abnormal VHI-10	10.53	8.33	3.44
1 yr. Post Op Abnormal VHI-10	10.53	8.33	0.00

Primary outcome: Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op

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. Mean (Standard Deviation). Unit: percentage of disability/difficulty

Measure	Control Group n = 21	IV Steroid n = 25	Local Steroid n = 29
Baseline NDI	40 (19)	34 (18)	35 (19)
1 Day Post Op NDI	27 (14)	28 (16)	27 (18)
2 wk. Post Op NDI	31 (20)	24 (15)	20 (16)
6 wk. Post Op NDI	23 (19)	21 (15)	24 (19)
3 mo. Post Op NDI	14.6 (40)	11.1 (23.3)	10 (23.5)
6 mo. Post Op NDI	23 (19)	21 (15)	24 (19)
1 yr. Post Op NDI	22.2 (33.6)	4.0 (18)	6.0 (26)

Primary outcome: Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op

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. Median (Inter-Quartile Range). Unit: Score on a scale

Measure	Control Group n = 21	IV Steroid n = 25	Local Steroid n = 29
VAS Pain Score (Baseline)	8.0 (6.00 to 9.00)	8.0 (6.00 to 9.00)	7.0 (4.00 to 9.00)
VAS Pain Score (1 Day Post Op)	7.00 (6.50 to 9.00)	6.00 (3.00 to 9.00)	6.00 (3.00 to 7.00)
VAS Pain Score (2 wk. Post Op)	6.00 (5.00 to 8.00)	4.00 (3.00 to 6.00)	4.00 (3.00 to 6.00)
VAS Pain Score (6 wk. Post Op)	5.00 (3.00 to 8.00)	4.00 (2.00 to 5.50)	5.00 (3.00 to 7.00)
VAS Pain Score (3 mo. Post Op)	4.5 (1.75 to 7.00)	3.0 (1.00 to 4.00)	3.00 (2.00 to 5.00)
VAS Pain Score (6 mo. Post Op)	5.0 (3.00 to 8.00)	4.0 (2.00 to 5.50)	5.00 (3.00 to 7.00)
VAS Pain Score (1 yr. Post Op)	4.0 (1.00 to 6.00)	2.0 (1.00 to 4.00)	1.0 (1.00 to 5.00)

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Control Group	0 of 0	0 of 0
IV Steroid	0 of 0	0 of 0
Local Steroid	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17906571Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
Background: PubMed 16891973Sanfilippo JA Jr, Lim MR, Jacoby SM, Laterra R, Harrop JS, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. "Normal" prevertebral soft tissue swelling following elective anterior cervical decompression and fusion. J Spinal Disord Tech. 2006 Aug;19(6):399-401. doi: 10.1097/00024720-200608000-00004.
Background: PubMed 12592551Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4.
Background: PubMed 22020609Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.
Background: PubMed 20051917McAfee PC, Cappuccino A, Cunningham BW, Devine JG, Phillips FM, Regan JJ, Albert TJ, Ahrens JE. Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal Disord Tech. 2010 Feb;23(1):1-8. doi: 10.1097/BSD.0b013e31819e2ab8.
Background: PubMed 19140539Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Decadron and Triamcinolone in people with Cervical Spine, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op (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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02577991, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.