A randomized study comparing an antireflux system with a direct ureteric anastomosis in patients with orthotopic ileal neobladders
Abstract
OBJECTIVE: To assess the benefit of an antireflux system in patients with orthotopic ileal neobladders, as there is controversy about whether reflux prevention offers any advantages.
PATIENTS AND METHODS: We conducted a randomized prospective study between January 2002 and March 2004, on 60 patients (53 men and seven women) with a mean (sd) age of 52.7 (7.3) years, who were candidates for orthotopic neobladders. Patients with comorbidities were excluded. Preoperative evaluation included intravenous urography (IVU), cystoscopic biopsy and radioisotope renography to evaluate the differential glomerular filtration rates (GFRs). Cases with normal kidneys and ureters, and with similar GFRs, were enrolled. Surgery comprised a standard radical cystectomy with pelvic lymphadenectomy. The ureters were randomized to either a direct anastomosis into a 5-cm ileal chimney on one side, or to be implanted using the antireflux serous-lined extramural tunnel on the contralateral side in the same patient. Regular follow-up included IVU and renography every 6 months in cancer-free patients.
RESULTS: The mean (sd) follow-up was 23 (9.6) months. There was prolonged urinary leak from a refluxing ureter in one patient that was treated with a temporary percutaneous nephrostomy. Symptomatic pelvic collections required tube drainage in six cases. Six ureters developed early anastomotic strictures (one direct and five antirefluxing), and were treated with endoscopic ureterotomy in three and open…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 53 participants or records.
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