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The Swedish reflux trial in children: I. Study design and study population characteristics.

Brandström, Per; Esbjörner, Elisabeth; Herthelius, Maria; Holmdahl, Gundela; Läckgren, Göran; Nevéus, Tryggve; Sillén, Ulla; Sixt, Rune; Sjöberg, Ingrid; Stokland, Eira; Jodal, Ulf; Hansson, Sverker.
J Urol; 184(1): 274-9, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20478580

PURPOSE:

We compared the rates of febrile urinary tract infection, kidney damage and reflux resolution in children with vesicoureteral reflux treated in 3 ways, including antibiotic prophylaxis, endoscopic therapy and surveillance with antibiotics only for symptomatic urinary tract infection.

MATERIALS AND METHODS:

Children 1 to younger than 2 years with grade III-IV reflux were recruited into this prospective, open, randomized, controlled, multicenter study and followed for 2 years after randomization. The main study end points were recurrent febrile urinary tract infection, renal status on dimercapto-succinic acid scintigraphy and reflux status. Outcomes were analyzed by the intent to treat principle.

RESULTS:

During a 6-year period 128 girls and 75 boys entered the study. In 96% of cases reflux was detected after urinary tract infection. The randomization procedure was successful and resulted in 3 groups matched for relevant factors. Recruitment was slower than anticipated but after patients were entered adherence to the protocol was good. Of the children 93% were followed for the intended 2 years without a treatment arm change. All except 2 patients completed 2-year followup scintigraphy.

CONCLUSIONS:

Recruitment was difficult but a substantial number of children were entered and randomly assigned to 3 groups with similar basic characteristics. Good adherence to the protocol made it possible to address the central study questions.
Selo DaSilva