NCT04717713

Brief Summary

Few methods were available to determine which muscle groups are associated with PD in details in previous investigations. Local steroid administration has shown some effects on PD in a large number meta-analysis. In this study, we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and the safety of the local steroid administration on ACDF patients by using high resolution impedance manometry in patients receiving ACDF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

August 1, 2023

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

January 18, 2021

Last Update Submit

July 30, 2023

Conditions

Swallowing Function

Outcome Measures

Primary Outcomes (1)

  • pharyngeal pressure

    muscle power at pharyngeal region

    preoperative, postoperative 1 month

Study Arms (2)

steroid group

EXPERIMENTAL

patients receiving steroid injection for preventing postoperative dysphagia

Drug: steroid injection

placebo group

PLACEBO COMPARATOR

patients receiving saline injection for comparator

Drug: placebo

Interventions

steroid injectionDRUG

steroid injection at surgical location

steroid group
placeboDRUG

saline injection at surgical location

placebo group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective anterior cervical spine surgery

You may not qualify if:

  • patients receiving spine surgery not at the first time
  • patients with head and neck cancer
  • patients receiving other surgeries at head and neck region
  • patients had previous swallowing difficulty history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 225, Taiwan

Location

MeSH Terms

Interventions

Steroids

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 22, 2021

Study Start

February 9, 2021

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

August 1, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

due to ethic concern

Locations

TW(1)