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Trial record 4 of 7 for:    "Esophageal Disease" | "Methylprednisolone"

Effect of Local Intraoperative Steroid on Dysphagia After ACDF

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ClinicalTrials.gov Identifier: NCT03311425
Recruitment Status : Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kern Singh, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE October 9, 2017
First Posted Date  ICMJE October 17, 2017
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE August 1, 2014
Actual Primary Completion Date June 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Change from baseline SWAL-QOL survey at 3 months [ Time Frame: 3 months ]
In the postoperative period, patients will be asked to complete the SWAL-QOL survey at the 3 month follow up office visit. This will be compared to preoperative scores. Each survey is scored out of 100 with minimum score of 20 indicating severe dysphagia and 100 indicating no dysphagia/normal swallowing. As such, a greater decrease in SWAL-QOL score from preoperative (baseline) to 3 month visit indicates greater postoperative swallowing difficulty.
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
Change from baseline SWAL-QOL survey at 3 months [ Time Frame: 3 months ]
In the postoperative period, patients will be asked to complete the SWAL-QOL survey at the 3 month follow up office visit.
Change History Complete list of historical versions of study NCT03311425 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Change from Baseline Prevertebral Soft Tissue Swelling at 3 months [ Time Frame: 3 months ]
    Prevertebral soft tissue swelling will be measured utilizing the standard of practice plain lateral radiographs that are obtained at the 3 month postoperative follow up office visit.The area of the prevertebral soft tissue density will be measured from the caudal border of C1 to the cranial end plate of C7 with a digital measuring instrument. These measurements will be compared to the preoperative measurements obtained utilizing the preoperative lateral plain radiographs which are also standard of practice.
  • Adverse Events [ Time Frame: 1 year ]
    Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Local Intraoperative Steroid on Dysphagia After ACDF
Official Title  ICMJE The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion
Brief Summary The purpose of this study is to determine if the incidence and duration of postoperative dysphagia are improved in the participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone.
Detailed Description Postoperative dysphagia is a known complication of anterior cervical spinal fusion (ACF) surgery with a published incidence that ranges from 1.7% to 50.3%.1-9 The pathophysiology of post-operative dysphagia is not fully understood and is subject to further study. Postoperative dysphagia has been reported to improve with time with a mean incidence of 19.8% at 6 months, 16.8% at 12 months, and 12.9% at 24 months after ACDF. The investigator's standard of practice is to provide 10mg of dexamethasone IV intraoperatively in order to reduce postoperative prevertebral soft tissue swelling. Despite the growing popularity of ACDF procedures, there is a lack of clear evidence supporting the utilization of perioperative corticosteroids in the setting of an ACDF.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Dysphagia
Intervention  ICMJE
  • Drug: Methylprednisolone
    Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure
  • Drug: Dexamethasone
    Administration of 10mg Dexamethasone IV intraoperatively
Study Arms  ICMJE
  • Active Comparator: Local Depomedrol plus IV dexamethasone
    Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
    Interventions:
    • Drug: Methylprednisolone
    • Drug: Dexamethasone
  • Placebo Comparator: IV dexamethasone
    Intraoperative systemic (IV) steroid (dexamethasone) only.
    Intervention: Drug: Dexamethasone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 11, 2017)
104
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 13, 2020
Actual Primary Completion Date June 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing a primary 1- to 3-level ACDF:

    (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis

  • Patients able to provide informed consent

Exclusion Criteria:

  • Allergies or other contraindications to medicines in the protocol including:

    (a) Existing history gastrointestinal bleeding

  • Existing history of dysphagia
  • Current Smokers
  • Cervical spine trauma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03311425
Other Study ID Numbers  ICMJE 13092002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kern Singh, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kern Singh, MD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP