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Swallowing Function Before and After Surgery for Thyroid Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00205348
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypothyroidism

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients undergoing thyroid surgery from May 2002 to December 2004 completed the SWAL-QOL questionnaire before and one year after surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SWAL-QOL Questionnaire

Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.

Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function.


Participant Flow:   Overall Study
    SWAL-QOL Questionnaire
STARTED   146 
COMPLETED   116 
NOT COMPLETED   30 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SWAL-QOL Questionnaire

Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.

Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function.


Baseline Measures
   SWAL-QOL Questionnaire 
Overall Participants Analyzed 
[Units: Participants]
 116 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      116 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      94  81.0% 
Male      22  19.0% 
Region of Enrollment 
[Units: Participants]
 
United States   116 


  Outcome Measures

1.  Primary:   Swallowing Quality of Life   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There are no limitations or caveats to report.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Herbert Chen
Organization: University of Wisconsin-Madison
phone: 608-263-1387
e-mail: chen@surgery.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205348     History of Changes
Other Study ID Numbers: 2002-093
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: June 22, 2012
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018