Does the site of the orthotopic neobladder outlet matter? A prospective randomized comparative study
Abstract
BACKGROUND: To compare the results of urethral anastomosis to a button hole and to the lowest part of the anterior suture line during orthotopic neobladder substitution.
METHODS: From January 2012 to December 2015, 87 consecutive male patients with invasive bladder cancer underwent radical cystectomy and Hautmann ileal neobladder. Patients were randomly divided into two groups; group I (44 patients), the outlet was created as a button-hole at the most dependent part of the pouch, group II (43 patients), the lowest 1 cm of the anterior suture line of the pouch was left open as an outlet. Patients were randomly assigned to either group using computer-generated random numbers (JMP, Version 12.0.1; SAS Institute, Cary, NC, USA) via a sealed envelope. The functional outcomes of both groups were compared especially at the urethro-enteric anastomosis.
RESULTS: There were no intraoperative complications. Early postoperative complications occurred in 9 patients (5 in group I and 4 in group II, p = 0.484). Prolonged urinary leakage persisted for 11 and 14 days in 2 patients in group I and 10 and 16 days in 2 patients in group II. Delayed postoperative complications occurred in 11 patients (5 [12.5%] in group I and 6 [15.6%] in group II) (p = 0.711). Three patients developed urethro-enteric strictures (2 in group I and 1 in group II) (p = 0.571).
CONCLUSION: The "non-hole" technique of urethral anastomosis was not associated with a significant increase in the complication rate when…
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: 87 participants or records.
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