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Detecting the Changes of Swallowing Function in Tongue Cancer Patients Receiving Mandibular-lip Split or Pull-through Resection Surgeries
Study Purpose
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).
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
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 complianceTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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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.
Arms
Experimental: pull through group
the patients receiving the pull though method during the tongue cancer surgery
Placebo Comparator: mandibular-lip split group
the patients receiving the traditional mandibular lip split method during the tongue cancer surgery
Interventions
Procedure: - pull through group
pull through method
Procedure: - mandibular-lip split group
traditional mandibular-lip split method
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Shih-Jung Cheng, MD,PhD
[email protected]
0223123456
For additional contact information, you can also visit the trial on clinicaltrials.gov.
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