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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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Swallowing Function

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 21, 2021
    Last Updated
    April 26, 2021
    Sponsor
    National Taiwan University Hospital
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    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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