Patients Receiving Anterior Cervical Spine SurgeryNCT03891940
Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach
An observational study of Patients Receiving Anterior Cervical Spine Surgery, run by National Taiwan University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Patients Receiving Anterior Cervical Spine Surgery
- What is being tested?
- patients recieving anterior cervical spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia
Who may be able to join
- 1. Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia 2. Aged from 20-80 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Changes of Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach- the Implication of High Resolution Impedance Manometry
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.
Read the detailed description
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.
- Being tested
- patients recieving anterior cervical spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients recieving anterior cervical spine surgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: patients recieving anterior cervical spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper esophageal sphincter pressure changes
upper esophageal sphincter pressure changes measured by the HRIM
Measured: everage 1 month in the perioperative period
Secondary outcomes (1)
hyoid bone movement
the distance of hyoid bone movement measured by the ultrasonography
Measured: everage 1 month in the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start26 Mar 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Receiving Anterior Cervical Spine SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891940
- Sponsor's protocol ID
- 201901089RINC
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35372473
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes of Swallowing Motor Function After Cervical Spine Surgery With Anterior Approach- the Implication of High Resolution Impedance Manometry
- ClinicalTrials.gov ID
- NCT03891940
- Acronym / sponsor ID
- 201901089RINC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving Anterior Cervical Spine Surgery | – | Procedure: patients recieving anterior cervical spine surgery1. Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia 2. Aged from 20-80 years old |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia
Key inclusion criteria (1 listed)
- 1. Patients who fulfill the criteria of anterior cervical spine surgery under general anesthesia 2. Aged from 20-80 years old
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients recieving anterior cervical spine surgeryAnterior 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 | Procedure or surgery | Patient receiving Anterior Cervical Spine Surgery |
Primary outcome
upper esophageal sphincter pressure changes
Time frame: everage 1 month in the perioperative period
upper esophageal sphincter pressure changes measured by the HRIM
1 secondary outcome
hyoid bone movement
Time frame: everage 1 month in the perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 35372473Lai 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Receiving Anterior Cervical Spine Surgery, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fon-Yih Tsuang, MD (+886972651124, tsuangfy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper esophageal sphincter pressure changes (time frame: everage 1 month in the perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03891940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.