Hyperparathyroidism, Secondary
Conditions
Brief summary
The aim of this study is to assess the clinical, laboratory and vascular calcification outcome within 6 months duration in patients undergoing surgical parathyroidectomy (total, subtotal, and total with autotransplantation)
Detailed description
All patients above the age of 18, with end stage renal disease maintained on regular hemodialysis and are indicated for surgical parathyroidectomy. The indications for parathyroidectomy included persistently elevated intact parathormone hormone levels of greater than 500 pg/mL, uncontrolled hypercalcaemia with hyperphosphataemia or clinical symptoms of secondary hyperparathyroidism refractory to medical treatment. These symptoms included bone pain, pruritus, fracture, fatigue and calciphylaxis These patients will be exposed to pre-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using ECG- gated non contrast CT in hemodialysis patients undergoing parathyroidectomy Post-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using non contrast CT will be done 6 months post-operative Assessment of the relation between preoperative and postoperative measures Patients with the following criteria will be excluded: 1. chronic kidney disease patients not yet on regular Hemodialysis 2. patients who had primary hyperparathyroidism 3. patients who had received kidney transplantation 4. patients who underwent repeated parathyroidectomy 5. patients who were lost to follow-up or with missing data.
Interventions
PROCEDUREsurgical parathyroidectomy
total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation
Sponsors
Mansoura General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients above the age of 18 * patients with End stage renal disease maintained on regular hemodialysis * indicated for surgical parathyroidectomy
Exclusion criteria
* Chronic kidney disease patients not yet on regular Hemodialysis * patients who had primary hyperparathyroidism * patients who had received kidney transplantation * patients who underwent repeated parathyroidectomy * patients who were lost to follow-up or with missing data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| emergent adverse postoperative events and assessment of the degree of vascular calcification | 6 months | assessment of emergent adverse postoperative events as bleeding, indication for mechanical ventilation and intensive care unit admission, vocal cord injury and development of hypoparathyroidism with persistent hypocalcemia assessment of degree of vascular calcification via measuring calcium scoring through ECG gated non contrast CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergent Adverse events on laboratory parameters | 6 months | assessment of s.calcium in mg/dl s.phosphorus ( mg/dl) and level of intact parathormone hormone in ( pg/mL) |
| Emergent Adverse events on Quality of life through assessing physical functioning, limitations due to physical health, limitations due to emotional problems, Energy/Fatigue, Emotional wellbeing, Social functioning, Pain, and General health | 6 months | Emergent Adverse events on Quality of life using short form 36 heath survey questionaire to assess physical functioning, limitations due to physical health, limitations due to emotional problems, Energy/Fatigue, Emotional wellbeing, Social functioning, Pain, General health |
| Emergent Adverse events on clinical status of the patient | 6 months | improvement of clinical symptoms related to hyperparathyroidism prior to surgery, occurrence of surgical complications related to parathyroidectomy procedure, cardiovascular problems, bone aches and disabilities, pruritis |
Countries
Egypt
Outcome results
None listed