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

• ClinicalTrials.gov Identifier: NCT06378931
• Recruitment Status: Not yet recruiting
• First Posted: April 23, 2024
• Last Update Posted: April 23, 2024
• Sponsor: Chunling Jiang
• Information provided by (Responsible Party): Chunling Jiang, West China Hospital

Tracking Information

• First Submitted Date: March 26, 2024
• First Posted Date: April 23, 2024
• Last Update Posted Date: April 23, 2024
• Estimated Study Start Date: April 15, 2024
• Estimated Primary Completion Date: December 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2024)

Measure quality of life scores change with respect to time [ Time Frame: up to 1 year ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 21, 2024)

• Measure anxiety and depression score change with respect to time [ Time Frame: up to 1 year ]
  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).
• Measure bone pain scores change with respect to time [ Time Frame: up to 1 year ]
  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.
• Length of hospital stay [ Time Frame: through study completion, an average of 1 week ]
  Determined by the number of days from admittance to discharge

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure
• Official Title: Quality of Life Change in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure: a Prospective Cohort Study
• Brief 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.
• Detailed 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure will be invited to participate in this study.

Condition

• Secondary Hyperparathyroidism
• End Stage Renal Failure

Intervention

Other: Quality of life progression after parathyroidectomy

Study the progression of quality of life.

Study Groups/Cohorts

Quality of life change in patients Undergoing Parathyroidectomy with end-stage renal failure

Quality of Life Progression in Patients Undergoing Parathyroidectomy With Secondary Hyperparathyroidism Due to End-stage Renal Failure

Intervention: Other: Quality of life progression after parathyroidectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 21, 2024): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2025
• Estimated Primary Completion Date: December 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Chunling Jiang, PhD; 18980601096; jiangchunling@scu.edu.cn

Contact: Chunling Jiang

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06378931
• Other Study ID Numbers: 2024HX161
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Chunling Jiang, West China Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Chunling Jiang
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Chunling Jiang; West China Hospital

• PRS Account: West China Hospital
• Verification Date: March 2024