PubMed · 2817030
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P Scherer. 1989. Shock Trauma.. https://pubmed.ncbi.nlm.nih.gov/2817030/
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Reconstruction of the lower urinary tract using intestinal segments has become a standard component of the treatment of patients with bladder cancer. A variety of intestinal segments can be successfully used for this purpose. Between 1986 and 1998, the authors have used a composite ileocolic segment for neobladder reconstruction in patients desiring orthotopic reconstruction of the lower urinary tract. The early and late complication rates are 11% and 30%, respectively. Forty-five percent of men are potent postoperatively. Seventy-six percent of patients are continent both day and night. Three percent of our patients experience nocturnal enuresis, and 15% perform clean intermittent catheterization. Bothersome daytime stress urinary incontinence occurs in 3% of patients evaluated for this report. Although no contemporary studies demonstrate the superiority of a particular bowel segment for lower urinary tract reconstruction, the authors' long-term experience with the ileocolic neobladder suggests that this composite segment provides excellent results for lower urinary tract reconstruction after radical cystectomy.
Beginning November 6, 1996, Food and Drug Administration regulation 21 CFR 50.24 has allowed research without consent in limited circumstances while requiring additional patient protection in the form of community consultation and disclosure. We report our experience in complying with these regulations in Multicenter Vest CPR protocol, the first investigational device study done under this new ruling. We found uncertainty in inter-pretation of the requirements for community consultation. The acceptance of research without consent varied among the parties exposed to this protocol, but neither physicians nor the lay public expressed major reservations. The consultation process was time-consuming, demanding, and relatively costly. Further clarification of the community consultation standard and additional dialogue on this important topic will help to foster additional research in cardiopulmonary resuscitation.