Document Detail


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.
MedLine Citation:
PMID:  21557796     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2011-05-09
Journal Detail:
Title:  BJU international     Volume:  109     ISSN:  1464-410X     ISO Abbreviation:  BJU Int.     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-01-03     Completed Date:  2012-02-21     Revised Date:  2012-06-20    
Medline Journal Info:
Nlm Unique ID:  100886721     Medline TA:  BJU Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  240-8     Citation Subset:  IM    
Copyright Information:
© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.
Affiliation:
Department of Urology, Academic Medical Centre, University of Amsterdam, The Netherlands. c.mamoulakis@amc.uva.nl
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MeSH Terms
Descriptor/Qualifier:
Aged
Double-Blind Method
Humans
Hyponatremia / etiology
Male
Postoperative Complications / etiology
Prospective Studies
Prostate / surgery*
Prostatic Hyperplasia / surgery*
Transurethral Resection of Prostate / adverse effects,  methods*
Treatment Outcome
Comments/Corrections
Comment In:
BJU Int. 2012 Apr;109(7):E22; author reply E22-4   [PMID:  22414177 ]
BJU Int. 2012 Jun;109(11):E38; author reply E38-40   [PMID:  22564326 ]

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