Swallowing Difficult Sensation After Cervical Spine Surgery | NCT04591665

Studies
Swallowing Difficult Sensation After Cervical Spine Surgery

NCT04591665

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

May 14, 2025Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Swallowing Disorder

Interventions

swallowing examination

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2020Actual

Primary Completion Date

Nov 8, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Oct 6, 2020

First Submission Date that Met QC Criteria

Oct 14, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2025

Last Update Posted Date

May 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. The investigator aimed to examine the correlation between high-resolution manometric and videofluoroscopic measurements of the swallowing function.

Detailed Description

Background: In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.

Objectives: The objective of the current study was to examine the correlation between high-resolution manometric and videofluoroscopic measurements of the swallowing function.

Patients and methods: Consecutive patients who will fulfill the criteria of postoperative cervical spine surgery patients aged >= 20 will be enrolled and the dysphagia questionnaire score (EAT-10) was higher than 3, including 3. After got the inform consent, these patients receive the swallowing function by videofluroscopy and HRIM.

Expected result: The investigator will evaluate the swallowing changes of these postoperative cervical spine patients with suspected dysphagia. The investigator expected that the highly correlation between the HRIM and VFSS.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
swallowing examination	Other	patients received swallowing examination, including high resolution impedance manometry and Video-Fluoroscopic swallowing study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pharyngeal pressure	the muscle power of pharyngeal contractility	15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 20 years old
postoperative cervical spine surgery
EAT-10 questionnaire

Exclusion Criteria:

pregnancy
bleeding tendency
heart or lung failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients after cervical spine surgery, EAT-10 and older than 20 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		10002	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42093049	Derived	Lai CJ, Tsuang FY, Jhuang JR, Hsiao MY, Cheng YJ, Chang YC, Chen JY. Reduced hypopharyngeal muscle strength in patients with dysphagia symptoms after anterior cervical discectomy and fusion. Perioper Med (Lond). 2026 May 7;15(1):59. doi: 10.1186/s13741-026-00691-4.

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases