Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

Nanjing Medical University

Status: Enrolling

Conditions: Secondary Hyperparathyroidism;Parathyroidectomy

Treatments: Procedure: Parathyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04922892

TOTAR-2021-05-31

Details and patient eligibility

About

Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.

Full description

The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Severe renal secondary hyperparathyroidism

Exclusion criteria

Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Total Parathyroidectomy Alone

Experimental group

Description:

Total Parathyroidectomy Alone , without autotransplantation

Treatment:

Procedure: Parathyroidectomy

Total Parathyroidectomy With Autotransplantation

Active Comparator group

Description:

Total Parathyroidectomy With Autotransplantation

Treatment:

Procedure: Parathyroidectomy