Detecting the Changes of Swallowing Function in Tongue Cancer Patients Receiving Mandibular-lip Split or Pull-through Resection Surgeries

April 26, 2021 updated by: National Taiwan University Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pull through group
the patients receiving the pull though method during the tongue cancer surgery
Procedure: pull through group
pull through method
Placebo Comparator: mandibular-lip split group
the patients receiving the traditional mandibular lip split method during the tongue cancer surgery
Procedure: mandibular-lip split group
traditional mandibular-lip split method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharyngeal pressure
Time Frame: 15 minutes during the examination postoperative 1 month
the contraction of pharyngeal muscle
15 minutes during the examination postoperative 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 27, 2021

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101035RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ethical concerns

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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