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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Secondary Hyperparathyroidism; End Stage Renal Failure
• Intervention / Treatment: Other: Quality of life progression after parathyroidectomy

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
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Chunling Jiang, PhD; Phone Number: 18980601096; Email: jiangchunling@scu.edu.cn
• Study Contact Backup: Name: Chunling Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Quality of life progression after parathyroidectomy; Study the progression of quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Length of hospital stay	Determined by the number of days from admittance to discharge	through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Chunling Jiang
• Investigators: Study Director: Chunling Jiang, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 21, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Parathyroid Diseases; Neoplastic Processes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hyperparathyroidism; Neoplasm Metastasis; Kidney Failure, Chronic; Renal Insufficiency; Hyperparathyroidism, Secondary
• Other Study ID Numbers: 2024HX161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No