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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04862637
Other study ID # 202101035RIND
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 27, 2021
Est. completion date December 31, 2027

Study information

Verified date April 2021
Source National Taiwan University Hospital
Contact Shih-Jung Cheng, MD,PhD
Phone 0223123456
Email sjcheng56@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The evidence of swallowing changes in tongue cancer patients receiving mandibular-lip split or pull-through resection surgeries is still limited. This study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM).


Description:

Objective: to investigated the swallowing changes in these patients receiving mandibular-lip split or pull-through resection surgeries by using the videofluoroscopy (VFSS) and high resolution impedance manometry (HRIM). Methods: 1. patients are fulfilled elective mandibular-lip split or pull-through resection surgeries; 2. they all received VFSS and HRIM exmination before surgery. 3. they were randomized into two groups (mandibular-lip split surgery or pull-through resection surgeries). 4. after receiving the surgery, the patients were followed the swallowing function at postoperative 1, 3, and 6 months. Anticipating results: the swallowing function at pull-through resection surgery has faster recovery than mandibular lip split methods.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - patients elective received tongue cancer surgery and suitable to receive mandibular-lip split or pull-through resection surgeries Exclusion Criteria: - 1. patients had major underlying disease, ex: heart, brain, lung, liver disease - 2. coagulopathy - 3.pregnancy - 4. the patients could not have good compliance

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
pull through group
pull through method
mandibular-lip split group
traditional mandibular-lip split method

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary pharyngeal pressure the contraction of pharyngeal muscle 15 minutes during the examination postoperative 1 month
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