ACSS-tilgangen til Dysfagi
Anterior Cervical Spine Strap Muscle Splitting versus Smith-Robinson-tilgangen: En Observationsstudie fra et Enkeltcenter
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Study Coordinator
- Telefonnummer: 44155 950-521-2100
- E-mail: martynia@mcmaster.ca
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L2X2
- Rekruttering
- Hamilton Health Sciences - Hamilton General Hospital
-
Kontakt:
- Study Coordinator
- Telefonnummer: 44155 905-521-2100
- E-mail: martynia@mcmaster.ca
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients undergoing index anterior cervical spinal surgery (C2-C7)
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Standard Smith-Robinson
Approach with incision between the strap muscles and the sternocleidomastoid |
|
Strap-splitting
Approach with incision splitting the infrahyoid strap muscles |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dysphagia as per the HSS-DDI
Tidsramme: 6 weeks post-operative
|
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms) |
6 weeks post-operative
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Længden af den intraoperative tid i minutter, justeret for kirurg, kirurgisk type og antal niveauer
Tidsramme: Operationstid
|
Operationstid
|
|
|
Skade på vitale neurovaskulære strukturer
Tidsramme: Tidspunktet for operationen
|
Tidspunktet for operationen
|
|
|
Blodtab under operation målt i mL
Tidsramme: Operationstid
|
Operationstid
|
|
|
Dysphagia as measured by the HSS-DDI
Tidsramme: post-operative day 1, 6 months, and 12 months
|
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms) |
post-operative day 1, 6 months, and 12 months
|
|
Changes in voice as measured by the HSS-DDI
Tidsramme: Post-operative day 1, 6 weeks, 6 months, and 12 months
|
Hospital for Special Surgery Dysphagia and Dysphonia Inventory, scored from 0 to 100, with higher scores indicating better function (less severity, fewer symptoms) |
Post-operative day 1, 6 weeks, 6 months, and 12 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17392
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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