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

Swallowing Function Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04862637
• Other study ID #: 202101035RIND
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Swallowing Function
• Tongue Neoplasms

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