ACSS Approach on Dysphagia

NCT07533864 | Recruiting

• 1 other identifier: 17392
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Anterior cervical spine surgery (ACSS) is a procedure for the treatment of several neck problems. Even though the procedure is overall safe and effective, there are possible complications after surgery, which include problems swallowing, hoarseness of the voice, and pain when swallowing. There are two different ways the spinal surgeon can approach the spine from the front of the neck. One is called a Smith-Robinson approach, and the other is called a strap-splitting approach. Each approach uses the same skin cut, the difference is only in how the next layer is approached, whether on the outside (Smith-Robinson) or through (strap-splitting) one of the small muscles in your neck. Because of the slightly different approaches to the surgery, we want to see if there are differences in complications related to swallowing and speaking between these two approaches. Participants will undergo one of the two surgical approaches, based on surgeon preference. Participants will complete a questionnaire at several time points during their clinical follow-up to assess any difficulties swallowing and speaking.

Conditions

Anterior Cervical Spine Surgery

Keywords

anterior cervical spine surgery; dysphagia; Smith-Robinson; strap-splitting

Outcome Measures

Primary Outcomes (1)

• Dysphagia as per the HSS-DDI

  6 weeks post-operative

Secondary Outcomes (5)

• Dysphagia as measured by the HSS-DDI

  post-operative day 1, 6 months, and 12 months

• Changes in voice as measured by the HSS-DDI

  Post-operative day 1, 6 weeks, 6 months, and 12 months

• Length of intraoperative time in minutes, adjusting for surgeon, surgical type, and number of levels

  Time of surgery

• Injury to vital neurovascular structures

  Time of surgery

• Blood loss during surgery measured in mL

  Time of surgery

Study Arms (2)

Standard Smith-Robinson

Approach with incision between the strap muscles and the sternocleidomastoid

Strap-splitting

Approach with incision splitting the infrahyoid strap muscles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing index anterior cervical spinal surgery (C2-C7)

You may qualify if:

• Adult patients (18 years of age or older).
• Patients undergoing anterior cervical spine surgery including Anterior cervical discectomy and fusion (ACDF), Anterior cervical arthroplasty (ACA) and Anterior cervical corpectomy and fusion (ACCF)
• Ability to complete HSS-DDI questionnaire in English

You may not qualify if:

• Planned use of anterior odontoid screws
• Revision anterior surgery
• Trauma patient

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Study Coordinator

CONTACT

950-521-2100; martynia@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

CA (1)