ACSS Approach on Dysphagia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anterior Cervical Spine Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Anterior Cervical Spine Strap Muscle Splitting Versus Smith-Robinson Approach: A Single-Centre Observational Study
Overview
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.
Primary outcome measures
- Dysphagia as per the HSS-DDI [Time frame: 6 weeks post-operative]
Secondary outcome measures (5)
- Dysphagia as measured by the HSS-DDI [Time frame: post-operative day 1, 6 months, and 12 months]
- Changes in voice as measured by the HSS-DDI [Time frame: 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 frame: Time of surgery]
- Injury to vital neurovascular structures [Time frame: Time of surgery]
- Blood loss during surgery measured in mL [Time frame: Time of surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Planned use of anterior odontoid screws
- Revision anterior surgery
- Trauma patient
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Canada · 1 center
- Hamilton Health Sciences - Hamilton General Hospital — Hamilton
Identifiers
NCT: NCT07533864 · 17392