Objectives To evaluate long-term outcome and quality of life after open and endovascular repair of ruptured abdominal aortic aneurysms. Methods All consecutive ruptured abdominal aortic aneurysm patients at the St. Antonius Hospital treated for ruptured abdominal aortic aneurysm between January 2005 and January 2015 were included. Mortality, morbidity, and re-interventions within 30 days and during follow-up were registered. Quality of life was measured with Short Form-36 questionnaire among survivors. Additional subgroup analysis between open repair and endovascular repair was performed. Results A total of 192 patients with ruptured abdominal aortic aneurysm were included: 76.6% (147/192) underwent open repair and 23.4% (45/192) endovascular repair. All-cause 30-day mortality rate was 31.3% (60/192), and 30-day morbidity rate was 70.3% (135/192). Median stay at the intensive care unit was two days for endovascular repair and four days for open repair ( p = 0.002). No other statistically significant differences between endovascular repair and open repair were observed. After a mean follow-up period of 62 months (range 9-126), 72.4% (76/105) of the responders had equivalent Short Form-36 scores as compared to the age-matched general Dutch population, and 84.2% (64/76) of the responders would choose surgery again if they would have a ruptured abdominal aortic aneurysm. Conclusions Survivors of ruptured abdominal aortic aneurysm have similar long-term quality of life scores compared to the age-matched general population. The majority of all survivors would choose to undergo acute abdominal aortic aneurysm repair again.
Objective To evaluate the relation between clinically relevant stricture recurrence after first urethroplasty and prior endoscopic treatments (dilatation and/or direct visual internal urethrotomy) or intermittent self‐dilatation (ISD). Methods Patients with bulbar urethral strictures treated with first urethroplasty between 2011 and April 2019 were included in a prospectively gathered database with standardized follow‐up. Stricture recurrence was defined as any need for reintervention. Primary outcome was the analysis of recurrence risk after first urethroplasty in relation with the number of prior endoscopic treatments or performance of ISD. Univariate and multivariate statistical analyses were performed. Results Overall, 106 patients were included with a median follow‐up of 12 months (interquartile range 8‐13]. Reintervention was necessary in 16 patients (15%). Recurrence was more prevalent in patients with ≥3 prior endoscopic treatments (28%, P = .009). No increased risk of recurrence was found in patients with 1 or 2 prior endoscopic treatments. The prevalence of prior ISD was twice as high in the stricture recurrence group (56% vs 26%, P = .014), and ISD was performed in 61% of the patients with ≥3 prior endoscopic treatments (P < .001). The number of prior endoscopic interventions and performance of ISD were no independent predictors for recurrence in the multivariable analysis. Conclusions This study shows that the risk of recurrence after first urethroplasty is increased in patients with ≥3 prior endoscopic treatments and in those who performed ISD. Patients performing ISD more often had ≥3 prior endoscopic treatments. Prior endoscopic treatment and performance of ISD were not independent predictors of stricture recurrence.
SamenvattingEen 62-jarige vrouw onderging een double barreled wet colostomy (DBWC) na een bekkenexenteratie. De DBWC is een relatief onbekende ingreep, waarbij een colostoma wordt aangelegd met twee openingen, waardoor urine en ontlasting via gescheiden compartimenten naar buiten worden geleid. Het doel van dit artikel is de DBWC te vergelijken met een gescheiden urostoma en colostoma aan de hand van een casus en een review van de beschikbare literatuur. Er werden drie retrospectieve studies gevonden die een DWBC vergeleken met een gescheiden uro- en colostoma, met in totaal 267 patiënten. Daaruit bleek geen verhoogde mortaliteit en morbiditeit bij een DBWC ten opzichte van een gescheiden urinestoma en colostoma. De conclusie luidt dat een DBWC kan worden overwogen na een bekkenexenteratie.
Background Ongoing research in the field of both localized, locally advanced and metastatic renal cell carcinoma has resulted in the availability of multiple treatment options. Hence, many questions are still unanswered and await further research. A nationwide collaborative registry allows to collect corresponding data. For this purpose, the Dutch PROspective Renal Cell Carcinoma cohort (PRO-RCC) has been founded, for the prospective collection of long-term clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs). Methods PRO-RCC is designed as a multicenter cohort for all Dutch patients with renal cell carcinoma (RCC). Recruitment will start in the Netherlands in 2023. Importantly, participants may also consent to participation in a ‘Trial within cohorts’ studies (TwiCs). The TwiCs design provides a method to perform (randomized) interventional studies within the registry. The clinical data collection is embedded in the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. PROMS entail Health-Related Quality of Life (HRQoL), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. Trial registration Ethical board approval has been obtained (2021_218) and the study has been registered at ClinicalTrials.gov (NCT05326620). Discussion PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, PROMS and PREMS. By facilitating an infrastructure for the collection of prospective data on RCC, PRO-RCC will contribute to observational research in a real-world study population and prove effectiveness in daily clinical practice. The infrastructure of this cohort also enables that interventional studies can be conducted with the TwiCs design, without the disadvantages of classic RCTs such as slow patient accrual and risk of dropping out after randomization.
This systematic review investigates how often and to what extent primary end points are changed and reported in immune checkpoint inhibitor clinical trials.
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