NCT01017055

Brief Summary

Evaluate voice and swallowing outcomes post operatively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
16.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

16.2 years

First QC Date

November 4, 2009

Last Update Submit

January 14, 2026

Conditions

DysphagiaDysphonia

Outcome Measures

Primary Outcomes (1)

  • Vocal cord and swallowing function as measured by fiberoptic exam in the otolaryngology clinic pre-op and approximately 3 weeks post op.

    4 weeks

Secondary Outcomes (1)

  • Quality of life as measured by a self-administered 10 point questionnaire.

    4 weeks

Study Arms (1)

Voice and Swallowing Evaluations

Other: Voice and Swallowing evaluations

Interventions

Voice and Swallowing evaluationsOTHER

Fiberoptic exam to evaluate vocal cord and swallowing function

Voice and Swallowing Evaluations

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing revision anterior cervical spine surgery

You may qualify if:

  • Patients undergoing revision anterior cervical spine surgery

You may not qualify if:

  • Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Deglutition DisordersDysphonia

Interventions

Voice

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiratory Tract DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • William R Carroll, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 20, 2009

Study Start

October 26, 2009

Primary Completion

December 25, 2025

Study Completion

January 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

US(1)