Results from an international multicentre double-blind randomized controlled trial on the perioperative efficacy and safety of bipolar vs monopolar transurethral resection of the prostate
Study Type - Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Short-term efficacy is similar but B-TURP is preferable due to a more favourable safety. a) first multicentre RCT, b) adequate quality, c) experience with a new bipolar device, d) morbidity stan...
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| Hauptverfasser: | , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2012
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| In: |
BJU international
Year: 2011, Jahrgang: 109, Heft: 2, Pages: 240-248 |
| ISSN: | 1464-410X |
| DOI: | 10.1111/j.1464-410X.2011.10222.x |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1111/j.1464-410X.2011.10222.x Verlag, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1464-410X.2011.10222.x 
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| Verfasserangaben: | Charalampos Mamoulakis, Andreas Skolarikos, Michael Schulze, Cesare M. Scoffone, Jens J. Rassweiler, Gerasimos Alivizatos, Roberto M. Scarpa, Jean J.M.C.H. de la Rosette |
| Zusammenfassung: | Study Type - Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Short-term efficacy is similar but B-TURP is preferable due to a more favourable safety. a) first multicentre RCT, b) adequate quality, c) experience with a new bipolar device, d) morbidity standardize using the modified Clavien classification system. OBJECTIVE • To compare the perioperative efficacy and safety of bipolar (B-) and monopolar transurethral resection of the prostate (M-TURP) in an international multicentre double-blind randomized controlled trial using the bipolar system AUTOCON® II 400 ESU for the first time. PATIENTS AND METHODS • From July 2006 to June 2009, consecutive transurethral resection of the prostate (TURP) candidates with benign prostatic obstruction were prospectively recruited in four academic urological centres, randomized 1:1 into an M-TURP or B-TURP arm and followed up for 6 weeks after surgery. • A total of 295 eligible patients were enrolled. • Of these, 279 patients received treatment (M-TURP, n= 138; B-TURP, n= 141) and were analysed for immediate postoperative outcomes and perioperative safety. In all, 268 patients (M-TURP, n= 129; B-TURP, n= 139) were analysed for efficacy, which was quantified using changes in maximum urinary flow rate, postvoid residual urine volume and International Prostate Symptom Score at 6 weeks compared with baseline. Safety was estimated using sodium and haemoglobin level changes immediately after surgery and perioperative complication occurrence graded according to the modified Clavien classification system. • Secondary outcomes included operation-resection time, resection rate, capsular perforation and catheterization time. RESULTS • No significant differences were detected between each study arm except that postoperative decreases in sodium levels favoured B-TURP (-0.8 vs -2.5 mmol/L, for B-TURP and M-TURP, respectively; P= 0.003). The lowest values were 131 mmol/L (B-TURP) and 106 mmol/L (M-TURP). Nine patients ranged between 125 and 130 mmol/L and the values for three patients were <125 mmol/L after M-TURP. The greatest decrease was 9 mmol/L after B-TURP (two patients). In nine patients (M-TURP) the decrease was between 9 and 34 mmol/L. • These results were not translated into a significant difference in TUR-syndrome rates (1/138: 0.7% vs 0/141: 0.0%, for M-TURP and B-TURP, respectively; P= 0.495). CONCLUSIONS • In contrast to the previous available evidence, no clinical advantage for B-TURP was shown. Perioperative efficacy, safety and secondary outcomes were comparable between study arms. • The potentially improved safety of B-TURP that is attributed to the elimination of dilutional hyponatraemia risk, a risk still present with M-TURP, did not translate into a significant clinical benefit in experienced hands. |
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| Beschreibung: | First published: 09 May 2011 Gesehen am 17.10.2018 |
| Beschreibung: | Online Resource |
| ISSN: | 1464-410X |
| DOI: | 10.1111/j.1464-410X.2011.10222.x |