Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach

NCT ID: NCT03891940

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-26

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dysphagia is a well-known complication following anterior cervical spine surgery. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The ultrasonography was used to measure the oropharyngeal swallowing function. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

we aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Dysphagia is a well-known complication following anterior cervical spine surgery. However, which muscle at oropharyngeal region weakness and the recovery course of these patients are still unknown.

The ultrasonography was used to measure the oropharyngeal swallowing function. The high resolution impedance manometry (HRIM) could be used to measure the postoperative recovery esophageal function.

We aimed to observe the changes and recovery course swallowing function parameters during the preoperative and postoperative period in the patients receiving anterior cervical spine surgery by HRIM and ultrasonography. Consecutive patients who will fulfill the criteria of cervical spine surgery patients under general anesthesia and aged \>= 20 will be enrolled. The patients would receive the dysphagia questionnaire. All subjects would receive the swallowing function by ultrasonography and HRIM before the surgeries. The cough test was also measured. After the surgery, the patient would be followed the swallowing function in the postoperative one day, 1 week, and 1 months, 3 months (If needed) by HRIM and ultrasonography.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Receiving Anterior Cervical Spine Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient receiving Anterior Cervical Spine Surgery

1. Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia
2. Aged from 20-80 years old

patients recieving anterior cervical spine surgery

Intervention Type PROCEDURE

Anterior cervical discectomy with fusion, or ACDF, is a surgery designed to relieve spinal cord or nerve root pressure in the neck by removing all or part of a damaged disc

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

patients recieving anterior cervical spine surgery

Anterior cervical discectomy with fusion, or ACDF, is a surgery designed to relieve spinal cord or nerve root pressure in the neck by removing all or part of a damaged disc

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1\. Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia 2. Aged from 20-80 years old

Exclusion Criteria

\- 1. Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.

2\. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. coagulopathy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fon-Yih Tsuang, MD

Role: CONTACT

+886972651124

Chih-Jun Lai, MD

Role: CONTACT

+886965327939

References

Explore related publications, articles, or registry entries linked to this study.

Lai CJ, Cheng YJ, Lai DM, Wu CY, Chang WT, Tsuang FY. Applying High-Resolution Impedance Manometry for Detecting Swallowing Change in Anterior Cervical Spine Surgery Patients. Front Surg. 2022 Mar 16;9:851126. doi: 10.3389/fsurg.2022.851126. eCollection 2022.

Reference Type DERIVED
PMID: 35372473 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201901089RINC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study: C-Collar and Dysphagia
NCT03349125 COMPLETED
Salt Water Gargling on Swallowing Following ACDF
NCT06475365 ENROLLING_BY_INVITATION NA