Modified malement with early vascular control versus modified retropubic prostatectomy in the management of benign prostatic hyperplasia - a randomised controlled trial.

Abstract

Background BPH is the most common benign tumor in men and its incidence varies with age, its >45% for men above 50 years globally. Internationally the Gold standard surgical management of severe symptomatic BPH is TURP, but in developing countries Uganda inclusive open prostatectomy remains the main surgical treatment modality. This is because TURP requires highly specialized training and the equipments are very expensive. The main challenge with open prostate surgery is intra and post operative haemorrhage. In this study, patients with severe symptomatic BPH were randomized to arm A and arm B. Arm A patients were operated using modified retropubic prostatectomy. In Arm B, the study group patients were operated using the modified malement method. Continuous bladder irrigation was initiated immediately after closure of the urinary bladder in all patients. The modification to the malement method was control of the lateral prostatic pedicles and the dorsal penile venous plexus before enucleation of the prostatic adenoma and the urethral catheter ballooned in the urinary bladder. After 72 hours the balloon was slightly deflated and pulled down into prostatic fossa. Objective : To compare the intra and post operative blood loss in patients operated by modified malement versus modified retropubic prostatectomy. Study design: Open label randomized controlled trial. Change in Haemoglobin and heamatocrit, amount of irrigant used, duration of irrigation, were recorded as absolute numbers, means and presented in tables. Data was analyzed using poisson xiii regression analysis. The power of the study was set at 80% with a confidence interval of 95% and a one sided P value of less than 0.05% considered statistically significant. Results. The mean reduction in Hb in arm A was 3.43g/dl and 3.2g/dl in arm B with a difference of means of 0.22g/dl (P value 0.625) which was not statistically significant. The mean reduction in Hct in arm A was 11.33% and 10.33% in arm B with a difference of means of 1.00% (P value 0.397 ) which was also not statistically significant. On average 28.71 Litres of normal saline was used for irrigation per person in arm A as compared to 5.82 Litres used per person in arm B and the difference was 22.89 Litres, which was both clinically and statistically significant at P value 0.001. The mean duration of irrigation was 2.12 days in arm A as compared to 1.22 days in arm B with a difference of 0.90 days (P value 0.001).This is both clinically and statistically significant. There was more clot retention in Arm A, 16 (44.44%) as compared to 11(32.35%) in Arm B (P-value 0.299), which was clinically significant however not statistically significant. Conclusion This study has therefore shown that the degree of haemorrhage in both methods is similar, P value >0.005. There was more clot retention in arm A than in arm B, despite the enormous amounts of irrigant used (28.71 Litres) compared to 5.82 L in arm B. This is both clinically and statistically significant and the duration of irrigation was shorter in arm B compared to arm A P value 0.001.This therefore means open prostatectomy by modified malement method has an advantage over modified retropubic method, as it requires less fluid for irrigation and puts less strain on the immediate post-operative nursing care.