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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
Author(s) -
Mamoulakis Charalampos,
Skolarikos Andreas,
Schulze Michael,
Scoffone Cesare M.,
Rassweiler Jens J.,
Alivizatos Gerasimos,
Scarpa Roberto M.,
de la Rosette Jean J.M.C.H.
Publication year - 2012
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2011.10222.x
Subject(s) - medicine , transurethral resection of the prostate , perioperative , perforation , randomized controlled trial , urology , prostate , international prostate symptom score , complication , surgery , lower urinary tract symptoms , cancer , materials science , punching , metallurgy
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.