BACKGROUND: For many years bilateral neck exploration (BNE) was the gold standard operation for primary hyperparathyroidism (pPHP). With advances in preoperative pathological gland localization and intraoperative parathyroid hormone (IPTH) monitoring, minimally invasive approaches have evolved. This study is aimed to compare BNE and focused parathyroidectomy (FP) in a prospective, randomized, blind trial. PATIENTS AND METHODS: Between 2005 and 2007, 48 patients with pPHP were enrolled in our study. Twenty three patients were randomized to the BNE group and 24 to the FP group. Patients in the FP group underwent preoperative localization studies. All parathyroidectomies were guided by intraoperative intact parathyroid hormone (IIPTH) monitoring. In the BNE group, neither IIPTH nor preoperative localization studies were performed. RESULTS: All patients were cured by the primary operation. Overall, the operative time was similar in both groups. In the focused exploration (FE) group, compared to the BNE group, there was lower pain intensity at 4, 8, 16, 24, 36 and 48 h after surgery (p < 0.001), lower consumption of analgesics (p < 0.001), lower analgesia request rate (p < 0.001), shorter scar length (p < 0.001), higher cosmetic satisfaction rate 2 days, 1 month (p < 0.001) and 6 months after surgery (p < 0.05), but after 1 year cosmetic satisfaction rate became not significant (p = 0.38). Focused exploration (FE) was more expensive (p < 0.05). We did not find any difference in quality of life after 1 month and 6 months after surgery in both groups. CONCLUSION: Both methods of parathyroidectomy for PHP are safe and effective. Focused exploration (FE) has several advantages: lower postoperative pain, lower analgesic request rate, lower analgesic consumption, shorter scar length, better cosmetic satisfaction rate in a short time period.
RCT Entities:
BACKGROUND: For many years bilateral neck exploration (BNE) was the gold standard operation for primary hyperparathyroidism (pPHP). With advances in preoperative pathological gland localization and intraoperative parathyroid hormone (IPTH) monitoring, minimally invasive approaches have evolved. This study is aimed to compare BNE and focused parathyroidectomy (FP) in a prospective, randomized, blind trial. PATIENTS AND METHODS: Between 2005 and 2007, 48 patients with pPHP were enrolled in our study. Twenty three patients were randomized to the BNE group and 24 to the FP group. Patients in the FP group underwent preoperative localization studies. All parathyroidectomies were guided by intraoperative intact parathyroid hormone (IIPTH) monitoring. In the BNE group, neither IIPTH nor preoperative localization studies were performed. RESULTS: All patients were cured by the primary operation. Overall, the operative time was similar in both groups. In the focused exploration (FE) group, compared to the BNE group, there was lower pain intensity at 4, 8, 16, 24, 36 and 48 h after surgery (p < 0.001), lower consumption of analgesics (p < 0.001), lower analgesia request rate (p < 0.001), shorter scar length (p < 0.001), higher cosmetic satisfaction rate 2 days, 1 month (p < 0.001) and 6 months after surgery (p < 0.05), but after 1 year cosmetic satisfaction rate became not significant (p = 0.38). Focused exploration (FE) was more expensive (p < 0.05). We did not find any difference in quality of life after 1 month and 6 months after surgery in both groups. CONCLUSION: Both methods of parathyroidectomy for PHP are safe and effective. Focused exploration (FE) has several advantages: lower postoperative pain, lower analgesic request rate, lower analgesic consumption, shorter scar length, better cosmetic satisfaction rate in a short time period.
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