Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure

Secondary Hyperparathyroidism Clinical Trial

Official title:

Quality of Life Change in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378931
• Other study ID #: 2024HX161
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: West China Hospital
• Contact: Chunling Jiang, PhD
• Phone: 18980601096
• Email: jiangchunling[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure.

Description:

Study participants will be asked questions about age, gender, education level, clinical symptoms, intensities of depression and anxiety, etc, and they will also be questioned regarding the prior quality of life score, as measured by the health-related quality of life 36-item Short-Form (SF-36) survey before surgery. Then, study participants will be contacted at one, three, six months, and 1 year after surgery, and asked questions about their SF-36 score, depression, and anxiety intensity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: =18 years old;
• Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure

Exclusion Criteria:

• Patients refuse to participate

Related Conditions & MeSH terms

• End Stage Renal Failure
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Neoplasm Metastasis
• Renal Insufficiency
• Secondary Hyperparathyroidism

Intervention

Other:
• Quality of life progression after parathyroidectomy
Study the progression of quality of life.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chunling Jiang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure quality of life scores change with respect to time	Quality of life will be assessed by the 36-Item short form health survey scale, Subjects complete one response from a range of options for each of the 36 questions. A combination of item response is then aggregated to calculate a score for each of the eight dimensions listed. The scores for each dimension range from 0 to 100, with higher scores indicating better health status	up to 1 year
Secondary	Measure anxiety and depression score change with respect to time	The anxiety and depression were evaluated using Hospital anxiety and depression Scale (HADS). The HADS consists of 14 questions, with 7 items each for the anxiety and depression subscales. The score for each item ranges from 0 to 3 points, and scores are summed to yield a separate score for anxiety (HADS-A) and depression (HADS-D).	up to 1 year
Secondary	Measure bone pain scores change with respect to time	The bone pain is evaluated using numerical rating scale (NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.	up to 1 year
Secondary	Length of hospital stay	Determined by the number of days from admittance to discharge	through study completion, an average of 1 week