Who should record surgical complications? Results from a third-party assessment of complications after radical cystectomy.

Objective: In Sweden complications after radical cystectomy have been reported to the nationwide population-based Swedish Cystectomy Registry since 2011. Here, validation of the reporting was assessed in two healthcare regions.Materials and methods: Complications were ascertained from patient records by a third party not involved in the care delivered to 429 randomly selected patients from 949 who had undergone radical cystectomy since 2011 in four hospitals. Without knowledge of the outcome in the primary registration, post-operative complications within 90 days post-operatively were assessed by an independent review of patient charts, and the results were compared with the primary reports in the Swedish Cystectomy Registry.Results: The third-party assessment identified post-operative complications in 310 patients (72%). Low-grade complications (Clavien-Dindo I-II) were noted in 110 (26%) of the patients in the primary registration, but increased to 182 (42%) in the validation (p < 0.00001). High-grade complications (Clavien-Dindo III-V) were reported in 113 (26%) patients in the primary registration, but in 128 (30%) of the patients in the validation (p = 0.02). According to the third-party assessment, 18 patients (4%) had Clavien-Dindo grade IV complications and 12 (3%) died within 90 days of surgery (Clavien-Dindo grade V); corresponding values in the primary registration were 15 (3%) and 9 (2%), respectively. The readmission rate within 90 days increased from 27 to 32% in the validation (p < 0.00001).Conclusions: Compared with registry data, third-party assessment revealed more complications and readmissions after radical cystectomy. Hence such evaluation may improve the validity of reported complication data.

Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder.

OBJECTIVES: To evaluate the response rate for intravesical gemcitabine given in three different schedules to patients with recurrent multiple carcinoma of the urinary bladder Stage Ta, grade 1-2, in whom all but one marker lesion was removed. Furthermore, we sought to define the safety profile. METHODS: This was a multicenter, open-label, randomized, Phase II study in which gemcitabine 2000 mg in 100 mL of unbuffered saline was instilled as a single dose (n = 11), two doses per week for 3 weeks (n = 11), or once weekly for 6 weeks (n = 10). Efficacy was evaluated using cystoscopy after 9 weeks. Toxicity was evaluated by assessing the liver, kidney, bone marrow, and coagulation function at defined intervals and by questionnaire. RESULTS: A total of 32 patients were included, 2 of whom were subsequently excluded because of protocol violations. The overall complete remission rate was 31%. The respective subgroup response rate was 10% in the single-dose group, 44% in the once-weekly group, and 40% in the twice-weekly group. The most common side effect was nausea. One patient withdrew because of nausea and fever, and an additional 2 patients had reversible hematologic toxicity (mild thrombocytopenia causing delayed instillation and mild anemia). The side effects were generally in the multiple-dose groups, with an overrepresentation in women. Ten patients were unable to retain the drug intravesically for the full hour. CONCLUSIONS: The results of our study have shown that gemcitabine has a tumor ablative effect when given intravesically for bladder cancer. A single dose seemed ineffective, and the multiple dosing regimens seemed effective. The side effects were generally mild.