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DysphoniaNCT07713693

Dysphagia and Dysphonia in Anterior Cervical Spinal Surgery

A study testing Fiberoptic Endoscopic Evaluation of Swallowing, 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life and EAT-10 questionnaire in people with Dysphonia and Dysphagia, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

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

Introduction: The anterior cervical approach is used to treat a variety of spinal disorders; among these, the Smith-Robinson approach is the most commonly used, as it allows access to discs, bony structures, and anterior lesions without directly affecting the spinal cord. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dysphonia, Dysphagia
What is being tested?
Fiberoptic Endoscopic Evaluation of Swallowing, 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life and EAT-10 questionnaire
Type of treatment
Surgery or procedure
How many people
36 participants
Where
1 siteMexico
Study dates
30 Nov 2019to 30 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Any age.
  • Any gender.
  • Diagnosis of narrow cervical canal; candidates for surgical management via an anterior cervical approach.
  • Patients treated in the spinal surgery department.
  • Patients who have signed an informed consent form.
  • Complete medical records.

Who cannot join

  • History of previous cervical surgery.
  • Psychiatric disorders.
  • ASA III and IV.
  • Smoking.
  • BMI > 30.
  • History of esophageal and/or laryngeal diseases (Barrett's syndrome, chronic esophagitis, laryngeal trauma, recurrent laryngitis, malformations).
Show all 9Show fewer
  • History of ankylosing spondylitis or any other rheumatic disease.
  • History of neurological disease.
  • Previous phoniatric condition.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra

    Mexico City, Mexico City, 14389

Other trials in Mexico

About this study

Introduction: The anterior cervical approach is used to treat a variety of spinal disorders; among these, the Smith-Robinson approach is the most commonly used, as it allows access to discs, bony structures, and anterior lesions without directly affecting the spinal cord. Its use has increased as anterior discectomies and fusions are performed more frequently. Among the complications, dysphonia and dysphagia are the most common.

Objectives: To describe the prevalence of dysphagia and dysphonia in patients with narrow cervical canal who were treated using an anterior cervical approach at the National Institute of Rehabilitation Materials and Methods: This study will consecutively enroll patients diagnosed with a narrow cervical canal who are treated using an anterior cervical approach at the INRLGII. The presence of dysphagia and dysphonia will be assessed in the postoperative period, at three months, and one year after surgery. Patients will be given rating scales to assess the presence and severity of symptoms during these three time periods.

Read more

Study design: A prospective, longitudinal, observational, descriptive cohort study.

Proposed statistical analysis: Clinical and demographic data will be described using summary measures (mean and median) for quantitative data and measures of dispersion (standard deviation, maximum, and minimum). The normality of the data will be tested using the Shapiro-Wilk test. The t-test will be applied to compare quantitative variables, and Pearson's chi-square test will be used for qualitative variables.

Read the detailed description

First Stage:

Upon admission of patients to the Spine Surgery Service with a prior diagnosis of cervical spinal stenosis, each patient will be informed about the surgical procedure, the type of approach, as well as the surgical risks and possible complications.

Second Phase:

Once patients agree to participate in the protocol, they will be given two scales. The first will be a vocal disability index, consisting of a 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life. The higher the score, the greater the disability. The second questionnaire is the EAT-10, a verbal, unidimensional, direct-scoring analog self-assessment scale designed to evaluate specific symptoms of dysphagia. It is a five-point scale (0-4 points), where zero (0) indicates the absence of the problem and four (4) indicates that the subject considers it a serious problem; higher scores will indicate a greater perception of dysphagia.

Third Phase:

This will take place during the postoperative period, approximately on the second or third day of recovery and before the patient begins eating solid foods. The questionnaires will be administered again to identify any differences and/or possible postoperative complications. Afterward, the patient will undergo a swallowing test, which involves inserting an endoscope (similar to a probe) through the nasal passage to the glottis, allowing visualization of the vocal cords. Subsequently, patients will swallow various food consistencies-liquid (water), semisolid (baby food), and solid (1/4 of a cookie)-viewed through a camera, reveal the state of the anatomical structures involved before and after swallowing. Prior to swallowing, the endoscope must be positioned on the soft palate, between the soft palate and the epiglottis, to visualize the base of the tongue and assess the passage of the food bolus into the pharynx; all of this is performed by a speech-language pathologist.

Conditions
Dysphonia, Dysphagia
Being tested
Fiberoptic Endoscopic Evaluation of Swallowing, 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life, EAT-10 questionnaire
Keywords
Dysphagia, Dysphonia, Anterior Cervical Spinal Surgery
Medical subject headings
Dysphonia, Deglutition Disorders

What participants receive

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

  • Fiberoptic Endoscopic Evaluation of SwallowingProcedure or surgery

    Involves inserting an endoscope (similar to a probe) through the nasal passage to the glottis, allowing visualization of the vocal cords. Subsequently, patients will swallow various food consistencies-liquid (water), semisolid (baby food), and solid (1/4 of a cookie)-viewed through a camera, reveal the state of the anatomical structures involved before and after swallowing. Prior to swallowing, the endoscope must be positioned on the soft palate, between the soft palate and the epiglottis, to visualize the base of the tongue and assess the passage of the food bolus into the pharynx; all of this is performed by a speech-language pathologist.

  • 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily lifeDiagnostic test

    The higher the score, the greater the disability.

  • EAT-10 questionnaireDiagnostic test

    It is a five-point scale (0-4 points), where zero (0) indicates the absence of the problem and four (4) indicates that the subject considers it a serious problem; higher scores will indicate a greater perception of dysphagia.

What is being measured

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

  1. Prevalence of dysphagia and dysphonia following anterior cervical spine surgery.

    Number and percentage of participants presenting postoperative dysphagia after anterior cervical spine surgery, assessed using the Eating Assessment Tool-10, Bazaz Dysphagia Score, Dysphagia Short Questionnaire, and Flexible Endoscopic Evaluation of Swallowing when applicable.

    Measured: 24 hours after surgery, 3 months after surgery, and 12 months after surgery

Secondary outcomes (8)
  1. Postoperative pain assessed using the Visual Analog Scale

    Postoperative pain intensity measured using the Visual Analog Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

    Measured: 24 hours after surgery, 3 months after surgery, and 12 months after surgery

  2. Cervical disability assessed using the Neck Disability Index

    Cervical disability measured using the Neck Disability Index. Scores range from 0 to 50, with higher scores indicating greater disability.

    Measured: Preoperative baseline, 3 months after surgery, and 12 months after surgery

  3. Myelopathy severity assessed using the modified Japanese Orthopaedic Association score

    Scale used to determine the degree of cervical spine disability according to upper-limb, lower-limb, and sphincter function. Scores range from 0 to 18, with lower scores indicating greater neurologic impairment.

    Measured: Preoperative baseline, 3 months after surgery, and 12 months after surgery

  4. Voice handicap assessed using the Voice Handicap Index

    Thirty-item questionnaire with a 0 to 4 scale for each item. It evaluates the impact of voice dysfunction on daily life; higher scores indicate greater disability

    Measured: Preoperative baseline, 3 months after surgery, and 12 months after surgery.

  5. Dysphagia-related handicap assessed using the Eating Assessment Tool-10

    Dysphagia-related symptoms measured using the Eating Assessment Tool-10. Scores range from 0 to 40, with higher scores indicating greater swallowing-related symptom burden.

    Measured: Preoperative baseline, 24 hours after surgery, 3 months after surgery, and 12 months after surgery.

  6. Length of hospital stay

    Number of days from surgery to hospital discharge.

    Measured: From date of surgery to date of hospital discharge, up to 30 days

  7. Postoperative complications

    Number and percentage of participants with postoperative complications after anterior cervical spine surgery.

    Measured: From surgery to 12 months after surgery.

  8. Quality of life assessed using the Short Form-36 Health Survey

    Health-related quality of life measured using the Short Form-36 Health Survey. Higher scores indicate better health-related quality of life.

    Measured: Preoperative baseline, 3 months after surgery, and 12 months after surgery.

Timeline

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

  1. First posted20 Jul 2026
  2. Study start30 Nov 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Dec 2021

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07713693
Sponsor's protocol ID
02/21
Status last verified
Jun 2026
First submitted
25 Jun 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Edwards CC 2nd, Karpitskaya Y, Cha C, Heller JG, Lauryssen C, Yoon ST, Riew KD. Accurate identification of adverse outcomes after cervical spine surgery. J Bone Joint Surg Am. 2004 Feb;86(2):251-6. doi: 10.2106/00004623-200402000-00006.

    PubMed 14960668
  • 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
  • Winslow CP, Winslow TJ, Wax MK. Dysphonia and dysphagia following the anterior approach to the cervical spine. Arch Otolaryngol Head Neck Surg. 2001 Jan;127(1):51-5. doi: 10.1001/archotol.127.1.51.

    PubMed 11177014
  • 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
  • Tan TP, Govindarajulu AP, Massicotte EM, Venkatraghavan L. Vocal cord palsy after anterior cervical spine surgery: a qualitative systematic review. Spine J. 2014 Jul 1;14(7):1332-42. doi: 10.1016/j.spinee.2014.02.017. Epub 2014 Mar 13.

    PubMed 24632183
  • Tervonen H, Niemela M, Lauri ER, Back L, Juvas A, Rasanen P, Roine RP, Sintonen H, Salmi T, Vilkman SE, Aaltonen LM. Dysphonia and dysphagia after anterior cervical decompression. J Neurosurg Spine. 2007 Aug;7(2):124-30. doi: 10.3171/SPI-07/08/124.

    PubMed 17688050
  • Acosta-Merida MA, Medina-Velazquez R, Marchena-Gomez J, Alonso-Gomez J, Mhaildli H. Dysphagia after cervical spine fusion caused by migration of the prosthetic material. Cir Esp. 2015 Oct;93(8):537-9. doi: 10.1016/j.ciresp.2015.05.005. Epub 2015 Jun 30. No abstract available. English, Spanish.

    PubMed 26139180
  • Chen CJ, Saulle D, Fu KM, Smith JS, Shaffrey CI. Dysphagia following combined anterior-posterior cervical spine surgeries. J Neurosurg Spine. 2013 Sep;19(3):279-87. doi: 10.3171/2013.6.SPINE121134. Epub 2013 Jul 12.

    PubMed 23848353
  • Joaquim AF, Murar J, Savage JW, Patel AA. Dysphagia after anterior cervical spine surgery: a systematic review of potential preventative measures. Spine J. 2014 Sep 1;14(9):2246-60. doi: 10.1016/j.spinee.2014.03.030. Epub 2014 Mar 21.

    PubMed 24662213
  • Fengbin Y, Xinwei W, Haisong Y, Yu C, Xiaowei L, Deyu C. Dysphagia after anterior cervical discectomy and fusion: a prospective study comparing two anterior surgical approaches. Eur Spine J. 2013 May;22(5):1147-51. doi: 10.1007/s00586-012-2620-5. Epub 2013 Jan 1.

    PubMed 23277296
  • Yu S, Chen Z, Yan N, Hou T, He S. Incidence and Factors Predictive of Dysphagia and Dysphonia After Anterior Operation With Multilevel Cervical Spondylotic Myelopathy. Clin Spine Surg. 2017 Nov;30(9):E1274-E1278. doi: 10.1097/BSD.0000000000000492.

    PubMed 28402988
  • Cheung KM, Mak KC, Luk KD. Anterior approach to cervical spine. Spine (Phila Pa 1976). 2012 Mar 1;37(5):E297-302. doi: 10.1097/BRS.0b013e318239ccd8.

    PubMed 22020587
  • SOUTHWICK WO, ROBINSON RA. Surgical approaches to the vertebral bodies in the cervical and lumbar regions. J Bone Joint Surg Am. 1957 Jun;39-A(3):631-44. No abstract available.

    PubMed 13428808
  • Rosenthal BD, Nair R, Hsu WK, Patel AA, Savage JW. Dysphagia and Dysphonia Assessment Tools After Anterior Cervical Spine Surgery. Clin Spine Surg. 2016 Nov;29(9):363-367. doi: 10.1097/BSD.0000000000000373.

    PubMed 26974878
  • Danto J, DiCapua J, Nardi D, Pekmezaris R, Moise G, Lesser M, Dimarzio P. Multiple cervical levels: increased risk of dysphagia and dysphonia during anterior cervical discectomy. J Neurosurg Anesthesiol. 2012 Oct;24(4):350-5. doi: 10.1097/ANA.0b013e3182622843.

    PubMed 22828154

Questions about this trial

What is this clinical trial studying?

A study testing Fiberoptic Endoscopic Evaluation of Swallowing, 30-item questionnaire designed to assess the impact of speech dysfunction on the patient's daily life and EAT-10 questionnaire in people with Dysphonia and Dysphagia, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.

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 6 inclusion and 9 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 6 Nov 2026. 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Prevalence of dysphagia and dysphonia following anterior cervical spine surgery. (time frame: 24 hours after surgery, 3 months after surgery, and 12 months after surgery). 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 NCT07713693, which also lists 18 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 6 Nov 2026.

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