DysphagiaDysDexVSSalNCT02416934

Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline

A study testing Treatment 1; Dexamethasone in people with Dysphagia, run by West Virginia 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

Search all trials

Trial summary

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Dysphagia
What is being tested?: Treatment 1; Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: Jul 2012to 15 May 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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Elective anterior approach to subaxial cervical spine (C3 - T1);
ages 18-80

Who cannot join

Traumatic or tumor etiologies
undergoing anterior-posterior operations
neoplastic, or infectious conditions requiring surgery
a history of previous anterior cervical spine surgery
any patient requiring a halo vest
patients on chronic steroids

Show all 10Show fewer

patients remaining intubated post-operatively (please see more under risks below)
less than 18 years of age
pregnant women
no phone

Trial locations and contacts

1 site in 1 country.

United States1 site

West Virginia University
Morgantown, West Virginia, 26506

Other trials in United States

About this study

Official title: The Effects of Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study.

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.

Read the detailed description

This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Conditions: Dysphagia
Being tested: Treatment 1; Dexamethasone, Treatment 0; Saline placebo
Medical subject headings: Deglutition Disorders

What participants receive

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

Treatment 1; DexamethasoneDrug
Also called Steroid
Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
Treatment 0; Saline placeboDrug
Also called Saline
Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.

Study groups in NCT02416934
Study group	Role	What they receive
Treatment 1; Dexamethasone	Experimental	Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. Receives: Drug: Treatment 1; Dexamethasone
Treatment 0; Saline placebo	Placebo comparator	Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. Receives: Drug: Treatment 0; Saline placebo

What is being measured

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

Swallowing Difficulty
Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.
Measured: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months

Secondary outcomes (2)

Change in Quality of Life
Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.
Measured: Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.
Fusion Rate Steroid vs Placebo
Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.
Measured: 1 year

Timeline

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

Jul 201215 May 2017

First posted15 Apr 2015 (estimated)
Study startJul 2012
Primary completion15 May 2016
Study completion15 May 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 (13)Papers the sponsor has linked to this study.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by West Virginia 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02416934
Sponsor's protocol ID: 1405296745
Acronym: DysDexVSSal
Status last verified: Jan 2019
First submitted: 9 Jan 2015
Last updated: 5 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Group data will be available via publication. Participants are told their randomization assignment at one year, or up to two year, follow up post surgery, dependent on their return to clinic.

Publications

Riley LH 3rd, Vaccaro AR, Dettori JR, Hashimoto R. Postoperative dysphagia in anterior cervical spine surgery. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S76-85. doi: 10.1097/BRS.0b013e3181d81a96.
PubMed 20407354
Fountas KN. Re: Papavero L, Heese O, Klotz-Regener V, et al. The impact of esophagus retraction on early dysphagia after anterior cervical surgery. Spine 2007;32:1089-93. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3090. doi: 10.1097/BRS.0b013e31815cd40f. No abstract available.
PubMed 18091507
Mendoza-Lattes S, Clifford K, Bartelt R, Stewart J, Clark CR, Boezaart AP. Dysphagia following anterior cervical arthrodesis is associated with continuous, strong retraction of the esophagus. J Bone Joint Surg Am. 2008 Feb;90(2):256-63. doi: 10.2106/JBJS.G.00258.
PubMed 18245583
Cavusoglu H, Tuncer C, Tanik C, Mutlu Z, Zengin E, Karabagli M, Aydin Y. The impact of automatic retractors on the esophagus during anterior cervical surgery: an experimental in vivo study in a sheep model. J Neurosurg Spine. 2009 Nov;11(5):547-54. doi: 10.3171/2009.6.SPINE09216.
PubMed 19929356
Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22.
PubMed 17321961
Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8.
PubMed 21140251
Siska PA, Ponnappan RK, Hohl JB, Lee JY, Kang JD, Donaldson WF 3rd. Dysphagia after anterior cervical spine surgery: a prospective study using the swallowing-quality of life questionnaire and analysis of patient comorbidities. Spine (Phila Pa 1976). 2011 Aug 1;36(17):1387-91. doi: 10.1097/BRS.0b013e31822340f2.
PubMed 21785303
Kang SH, Kim DK, Seo KM, Kim KT, Kim YB. Multi-level spinal fusion and postoperative prevertebral thickness increase the risk of dysphagia after anterior cervical spine surgery. J Clin Neurosci. 2011 Oct;18(10):1369-73. doi: 10.1016/j.jocn.2011.02.033. Epub 2011 Jul 27.
PubMed 21798743
Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
PubMed 12435974
Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. doi: 10.1097/01.brs.0000186317.86379.02.
PubMed 16284596
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
Emery SE, Akhavan S, Miller P, Furey CG, Yoo JU, Rowbottom JR, Bohlman HH. Steroids and risk factors for airway compromise in multilevel cervical corpectomy patients: a prospective, randomized, double-blind study. Spine (Phila Pa 1976). 2009 Feb 1;34(3):229-32. doi: 10.1097/BRS.0b013e318193a287.
PubMed 19148042
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

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?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux

All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study.
ClinicalTrials.gov ID: NCT02416934
Acronym / sponsor ID: DysDexVSSal / 1405296745
Conditions: Dysphagia
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: West Virginia UniversityUniversity, hospital or other
Study start: Jul 2012
Primary completion: 15 May 2016 (actual)
Study completion: 15 May 2017 (actual)
First posted: 15 Apr 2015 (estimated)
Results: Posted 30 Mar 2018

Clinical summary

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

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment 1; Dexamethasone	Experimental	Drug: Treatment 1; DexamethasonePatients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.
Treatment 0; Saline placebo	Placebo comparator	Drug: Treatment 0; Saline placeboPatients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Elective anterior approach to subaxial cervical spine (C3 - T1);
ages 18-80

Key exclusion criteria (10 listed)

Traumatic or tumor etiologies
undergoing anterior-posterior operations
neoplastic, or infectious conditions requiring surgery
a history of previous anterior cervical spine surgery
any patient requiring a halo vest

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
Treatment 1; DexamethasoneAlso: SteroidDexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Drug	Treatment 1; Dexamethasone
Treatment 0; Saline placeboAlso: SalineSaline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Drug	Treatment 0; Saline placebo

Primary outcome

Swallowing Difficulty
Time frame: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months
Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.

2 secondary outcomes

Change in Quality of Life
Time frame: Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.
Fusion Rate Steroid vs Placebo
Time frame: 1 year

Results and safety

Results posted to the registry on 30 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment 1; Dexamethasone	36	33
Treatment 0; Saline Placebo	38	31

Primary outcome: Swallowing Difficulty

Time frame: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months. Count of participants. Unit: Participants

Measure	Dexamethasone DSQ n = 33	Saline Placebo DSQ n = 31	Dexamethasone Bazaz n = 33	Saline Placebo Bazaz n = 31
Difficulty swallowing Baseline	16	14	5	7
Difficulty swallowing day 1	24	28	19	21
Difficulty swallowing day 2	22	28	15	23
Difficulty swallowing Week 1	29	28	14	21
Difficulty swallowing Week 2	23	27	14	19
Difficulty swallowing Month 1	19	24	13	17
Difficulty swallowing Month 3	9	17	3	11
Difficulty swallowing Month 6	6	11	2	10

Dexamethasone DSQ vs Saline Placebo DSQ: Mean Difference (Final Values): -1.5392 (95% CI -2.9761 to -.1022), p = 0.036, t-test, 2 sided
Dexamethasone Bazaz vs Saline Placebo Bazaz: Mean Difference (Final Values): -.6040 (95% CI -1.1151 to -.0930), p <.05, t-test, 2 sided

Population analysed: Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment 1; Dexamethasone	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Treatment 0; Saline Placebo	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20407354Riley LH 3rd, Vaccaro AR, Dettori JR, Hashimoto R. Postoperative dysphagia in anterior cervical spine surgery. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S76-85. doi: 10.1097/BRS.0b013e3181d81a96.
Background: PubMed 18091507Fountas KN. Re: Papavero L, Heese O, Klotz-Regener V, et al. The impact of esophagus retraction on early dysphagia after anterior cervical surgery. Spine 2007;32:1089-93. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3090. doi: 10.1097/BRS.0b013e31815cd40f. No abstract available.
Background: PubMed 18245583Mendoza-Lattes S, Clifford K, Bartelt R, Stewart J, Clark CR, Boezaart AP. Dysphagia following anterior cervical arthrodesis is associated with continuous, strong retraction of the esophagus. J Bone Joint Surg Am. 2008 Feb;90(2):256-63. doi: 10.2106/JBJS.G.00258.
Background: PubMed 19929356Cavusoglu H, Tuncer C, Tanik C, Mutlu Z, Zengin E, Karabagli M, Aydin Y. The impact of automatic retractors on the esophagus during anterior cervical surgery: an experimental in vivo study in a sheep model. J Neurosurg Spine. 2009 Nov;11(5):547-54. doi: 10.3171/2009.6.SPINE09216.
Background: PubMed 17321961Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22.
Background: PubMed 21140251Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8.
Background: PubMed 21785303Siska PA, Ponnappan RK, Hohl JB, Lee JY, Kang JD, Donaldson WF 3rd. Dysphagia after anterior cervical spine surgery: a prospective study using the swallowing-quality of life questionnaire and analysis of patient comorbidities. Spine (Phila Pa 1976). 2011 Aug 1;36(17):1387-91. doi: 10.1097/BRS.0b013e31822340f2.
Background: PubMed 21798743Kang SH, Kim DK, Seo KM, Kim KT, Kim YB. Multi-level spinal fusion and postoperative prevertebral thickness increase the risk of dysphagia after anterior cervical spine surgery. J Clin Neurosci. 2011 Oct;18(10):1369-73. doi: 10.1016/j.jocn.2011.02.033. Epub 2011 Jul 27.
Background: PubMed 12435974Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.
Background: PubMed 16284596Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. doi: 10.1097/01.brs.0000186317.86379.02.
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 19148042Emery SE, Akhavan S, Miller P, Furey CG, Yoo JU, Rowbottom JR, Bohlman HH. Steroids and risk factors for airway compromise in multilevel cervical corpectomy patients: a prospective, randomized, double-blind study. Spine (Phila Pa 1976). 2009 Feb 1;34(3):229-32. doi: 10.1097/BRS.0b013e318193a287.
Individual participant dataSharing planned: Yes. Group data will be available via publication. Participants are told their randomization assignment at one year, or up to two year, follow up post surgery, dependent on their return to clinic.

Related trials for Dysphagia

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux

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.

Sanford E Emery, MD, MBA principal investigator

West Virginia University

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

Questions about this trial

What is this clinical trial studying?

A study testing Treatment 1; Dexamethasone in people with Dysphagia, run by West Virginia 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 10 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 5 Feb 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. Some participants in this study may receive a placebo. 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 Mar 2018). 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?

Swallowing Difficulty (time frame: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months). 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 NCT02416934, which also lists 13 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 5 Feb 2019.