Plasmakinetic Enucleation of the Prostate Compared with Open Prostatectomy for Prostates Larger Than 100 Grams: A Randomized Noninferiority Controlled Trial with Long-term Results at 6 Years
| Autor: | Shushang Chen, Weizhen Wu, Shunliang Yang, Zhengrong Zheng, Lianming Liao, Rong Ge, Lingfeng Zhu, Hao Zhou, Zhen Deng, Jianming Tan, Meijing Wu, Jinquan Cai |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Urology media_common.quotation_subject Operative Time Enucleation Prostatic Hyperplasia Urination law.invention Hemoglobins Randomized controlled trial law Clinical endpoint Humans Medicine Prospective Studies Aged media_common Prostatectomy business.industry Prostate Organ Size Perioperative Length of Stay Middle Aged Intention to Treat Analysis Surgery Urodynamics Quality of Life Mann–Whitney U test International Prostate Symptom Score Urinary Catheterization business Follow-Up Studies Open Prostatectomy |
| Zdroj: | European Urology. 66:284-291 |
| ISSN: | 0302-2838 |
| Popis: | Background Studies have demonstrated that plasmakinetic enucleation of the prostate (PKEP) and open prostatectomy (OP) have equivalent short-term efficacy for large prostates, but no comparison concerning their long-term results was reported. Objective To demonstrate the noninferiority of PKEP to OP concerning maximum urinary flow rate (Q max ) at 1 yr postoperatively and to compare the long-term results of both procedures. Design, setting, and participants From 2004 to 2007, 160 patients with prostates >100g were randomized to receive PKEP or OP. A total of 153 patients (95.6%) completed the noninferiority study, and 123 patients (76.9%) finished a 6-yr follow-up assessment. Intervention The PKEP procedures were performed with 27F Karl Storz continuous flow resectoscopy and the Gyrus PlasmaKinetic device. OP was performed by a suprapubic transvesical approach. Outcome measurements and statistical analysis The primary end point was Q max at 1 yr postoperatively. Secondary end points included other perioperative parameters and postoperative micturition variables. The student t test, Mann-Whitney U test, chi-square test, or Fisher exact probability test was used as appropriate. Results and limitations PKEP was noninferior to OP regarding Q max at 1 yr postoperatively. Compared with OP, PKEP was associated with less perioperative hemoglobin decrease, shorter catheterization time, and shorter postoperative hospital stay (1.0 vs 3.2g/dl, 40 vs 148h, and 3 vs 8 d, respectively ; p p =0.031). On intention-to-treat analysis, both the PKEP and OP groups had equivalent Q max (25.2±7.0ml/s vs 25.7±7.6ml/s, respectively; p =0.688), International Prostate Symptom Score (3.5 [2–5] vs 3 [2–5], respectively p =0.755), quality of life (2 [1–3] vs 2 [1–3], respectively; p =0.950), and postvoid residual urine (20 [9–33.5] vs 16.5 [7–31] ml, respectively; p =0.469) at 72 mo postoperatively. No patients required reoperation because of recurrence of BPH. The relatively small sample size is the limitation. Conclusions PKEP is a durable procedure with short- to long-term micturition improvement equivalent to OP and significantly lower perioperative morbidity. Patient summary We compared PKEP with OP for large prostates and found that PKEP is less invasive, with short- to long-term micturition improvement equivalent to OP. Trial registration Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates. ClinicalTrials.gov identifier NCT01952912. http://www.clinicaltrials.gov/ct2/show/NCT01952912?term=NCT016301952912&rank=1. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect