Randomized Controlled Trial Of Total Parathyroidectomy With Or Without Autotransplantation For Secondary Hyperparathyroidism

Objective Surgical is a safe and effective means for secondary hyperparathyroidism(SHPT)patients with chronic renal failure.Subtotal parathyroidectomy(SPTX);total parathyroidectomy with autotransplantation(TPTX+AT)and total parathyroidectomy,(TPTX)are the standard surgical procedures.At present,there is only one prospective randomized controlled study to study the efficacy of different surgical methods.Which surgical method to choose is still more controversial in clinical practice.The clinical retrospective study showed that TPTX can significantly reduce postoperative recurrence,without increasing postoperative complications.The present study was to conduct a randomized controlled trial to evaluate the surgical procedures of TPTX+AT and TPTX.Explore the possible differences in the efficacy of the two surgical treatments for SHPT patients.Methods From September 2015 to September 2016,87 consecutive patients were randomized to a TPTX+AT group(n=44)and TPTX group(n=43).clinical manifestation,Intact parathyroid hormone(i PTH),serum calcium,serum phosphorus,calcium-phosphorus product were statistically analyzed before operation;1 week,3months after the operation.Postoperative clinical manifestation,complications and recurrence were observed.The Kidney Disease Quality of Life Short Form(KDQOL-SFTM)1.3 scale was used to assess the quality of life before and 3 months after surgery.Through comparing the postoperative complications,recurrence rate and quality of life,compare the advantages and disadvantages of the two surgical methods.This study was approved by the hospital's ethics committee.TrialRegistration:Clinical Trials.gov NCT 02536287.Results 1.The surgery was performed successfully in 85 cases(96.55%;TPTX+AT:43/44,TPTX:42/43).Recurrence happened in 1 patients(1.15%)and 1 people died(1.15%)3 months after operation.One day after surgery,one week after surgery,and three months after operation,the serum calcium and phosphorus levels in the two groups decreased significantly compared with the preoperative ones.There are statistical differences.The clinical symptoms of the two groups of patients after surgery were significantly improved compared with before surgery.Temporary injury of recurrent laryngeal nerve was found in 11 patients(12.64%).Transient postoperative hypocalcemia was frequently seen in 84 patients(95.40%);there are still 33 cases(37.93%)occured persistent hypocalcemia,need long-term intravenous calcium supplement 3 months after operation.2.There was no statistical difference in age(44.64 y vs 44.88y),weight(59.14 kg vs61.78 kg);preoperative PTH(1708.82 pg/m L vs 1782.45 pg/m L),serum calcium(2.39mmol/l vs 2.48 mmol/l),phosphorus(2.25 mmol/l vs 2.30 mmol/l),and dialysis time(6.14 y vs 6.58y)between the two groups;there was no statistical difference in bone pain,skeletal deformity,pruritus,and other clinical manifestations;There was no statistically significant difference in quality of life.There are no significant differences between the total parathyroidectomy with autotransplantation group and total parathyroidectomy group in average operating time(119.16 min vs 120.67min;P=0.824).The incidence of complication and hypocalcemia after operation are similar in the two groups.Postoperative physical functioning,sleep,bodily pain,general health,social functioning,report health transition,symptom / problems,effects of kidney disease,sexual function,role physical increased significantly compared with preoperative All patients were followed up for 3 months,the total score of SF-36: role physical(RP,48.86 vs 36.05;P=0.008);Social functioning(SF,57.27 vs 67.73;P=0.007);Health transition(HT,76.70 vs 84.88;P=0.014)are different in the two groups.The score of Sleep in kidney disease and dialysis related quality of life are different in the two groups(60.80 vs 68.14;P=0.036).Conclusions1.This prospective randomized controlled trial demonstrated that both TPTX and TPTX+AT are safe and effective treatments for SHPT.2.The improvement of quality of life after TPTX was better than that of TPTX+AT,especially in social function,health changes,and sleep;there was no difference in the recurrence rate after TPTX and TPTX+AT,and it is still necessary to follow-up to explore the differences in the recurrence rate after TPTX and TPTX+AT.