Detecting the Changes of Swallowing Function in Tongue Cancer Patients Receiving Mandibular-lip Split or Pull-through Resection Surgeries
Primary Purpose
Swallowing Function
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pull through group
mandibular-lip split group
Sponsored by
About this trial
This is an interventional treatment trial for Swallowing Function
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
pull through group
mandibular-lip split group
Arm Description
the patients receiving the pull though method during the tongue cancer surgery
the patients receiving the traditional mandibular lip split method during the tongue cancer surgery
Outcomes
Primary Outcome Measures
pharyngeal pressure
the contraction of pharyngeal muscle
Secondary Outcome Measures
Full Information
NCT ID
NCT04862637
First Posted
April 21, 2021
Last Updated
April 26, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04862637
Brief Title
Detecting the Changes of Swallowing Function in Tongue Cancer Patients Receiving Mandibular-lip Split or Pull-through Resection Surgeries
Official Title
Using High Resolution Impedance Manometry (HRIM) Combined With Videofluoroscopic Swallow Study (VFSS) to Investigate the Changes of Swallowing Function in Tongue Cancer Patients Receiving Mandibular-lip Split or Pull-through Resection Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 27, 2021 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pull through group
Arm Type
Experimental
Arm Description
the patients receiving the pull though method during the tongue cancer surgery
Arm Title
mandibular-lip split group
Arm Type
Placebo Comparator
Arm Description
the patients receiving the traditional mandibular lip split method during the tongue cancer surgery
Intervention Type
Procedure
Intervention Name(s)
pull through group
Intervention Description
pull through method
Intervention Type
Procedure
Intervention Name(s)
mandibular-lip split group
Intervention Description
traditional mandibular-lip split method
Primary Outcome Measure Information:
Title
pharyngeal pressure
Description
the contraction of pharyngeal muscle
Time Frame
15 minutes during the examination postoperative 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-Jung Cheng, MD,PhD
Phone
0223123456
Email
sjcheng56@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Jun Lai, MD
Phone
0223123456
Email
littlecherrytw@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
ethical concerns
Learn more about this trial
Detecting the Changes of Swallowing Function in Tongue Cancer Patients Receiving Mandibular-lip Split or Pull-through Resection Surgeries
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