Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study.

BACKGROUND: The use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. METHODS: Multicenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024. DISCUSSION: The scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript. TRIAL REGISTRATION: NCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021.

Can we identify those patients who will benefit from prostate-sparing surgery? Predictive factors for invasive prostatic involvement by transitional cell carcinoma.

OBJECTIVES: To determine which patients may benefit from prostate-sparing surgery and which factors are predictive of invasive prostatic involvement. MATERIALS AND METHODS: A total of 717 men underwent radical cystoprostatectomy (RC) for bladder transitional cell carcinoma (TCC) between 1978 and 2002. Analysis of prostatic urethral involvement by transitional cell carcinoma (pTCC) and of invasive prostatic involvement by TCC was performed according to recurrence, presence of carcinoma in situ (CIS) and multifocality, previous intravesical chemotherapy, grade, stage and location of bladder tumor, presence of CIS in precystectomy transurethral resection (TUR) and indication for RC. RESULTS: pTCC was present in specimens from 140 patients (19.5%), of whom 83 (59.3%) showed invasive prostatic involvement. Tumor location at the trigone or bladder neck (p = 0.011, OR 2.29, 95% CI 1.21-4.33) and a history of CIS (p = 0.003, OR 2.03, 95% CI 1.27-3.22) were independent predictors of pTCC. Presence of a solitary T2-T3 bladder tumor was a predictive factor for invasive prostatic involvement (p = 0.001, OR 3.73, 95% CI 1.70-8.16). Neither solitary tumors nor T2-T3 bladder tumors showed significant differences in 5 year specific survival (p = 0.277 and p = 0.618 respectively) when comparing patients according to the presence of superficial or invasive prostatic involvement. Bladder tumor stage in precystectomy TUR was a predictor of disease-specific survival (p = 0.018, OR 1.62, 95% CI 1.08-2.44). CONCLUSIONS: Patients with a history of CIS and bladder tumor location at the trigone or bladder neck are not candidates for prostate-sparing surgery. The only variables that can predict invasive prostatic involvement are the presence of a solitary T2-T3 bladder tumor at the trigone or bladder neck.

The case for conservative management in the treatment of patients with non-muscle-invasive micropapillary bladder carcinoma without carcinoma in situ.

INTRODUCTION: Micropapillary carcinoma is a rare pathologic variant of urothelial cell carcinoma. Intravesical bacillus Calmette-Guérin (BCG) has been reported to be ineffective and to entail an increased risk of development of non-organ-confined, metastatic disease. We assess the treatment response and disease progression in patients with micropapillary carcinoma of the bladder. MATERIALS AND METHODS: The study comprised 18 patients with micropapillary carcinoma of the bladder who underwent transurethral resection of a bladder tumor and multiple random biopsies between 1997 and 2003. We retrospectively analyzed treatment response and clinical and pathological cancer evolution related to cancer stage and the percentage of the micropapillary component of the cancer. RESULTS: Seven of the 18 patients (38.8%) had carcinoma in situ. At diagnosis, 8 of the 18 patients had non-muscle-invasive bladder cancer; 6 of these patients were treated with intravesical BCG therapy and were alive and free of disease at a median follow up of more than 5 years. Ten of the 18 patients had muscle-invasive bladder cancer; 8 of these patients underwent radical cystectomy, and 7 of the 8 patients (87.5%) had non-organ-confined disease in cystectomy specimens. Seventy percent of patients with muscle-invasive disease at diagnosis had a micropapillary carcinoma component of more than 50% in transurethral resection of the bladder specimens, compared with only 25% of patients with non-muscle-invasive disease. Patients treated successfully with intravesical BCG therapy had a low micropapillary carcinoma component. The 5-year disease-specific survival rate was significantly lower in patients with muscle-invasive disease (30%) than in patients with non-muscle-invasive disease (87.5%) after a median follow up of 52 months (p = 0.001), and it was also significantly lower in patients with a high percentage of the micropapillary component of the carcinoma. CONCLUSIONS: This retrospective study of 18 patients with micropapillary carcinoma of the bladder suggests that tumor stage and patient outcome may be related to the percentage of the micropapillary component of the carcinoma. Radical surgery is mandatory in muscle-invasive disease, even though patients with lymph node involvement die from the disease. In non-muscle-invasive disease and in the absence of associated carcinoma in situ, intravesical BCG treatment may be offered when the micropapillary component of the carcinoma component is a small percentage.

Efficiency of endoscopic treatment for vesico-ureteric reflux in adults.

OBJECTIVE: To evaluate the results of our experience with endoscopic management of vesico-ureteric reflux (VUR) in adults, and to describe factors and complications that might contribute to the failure of the technique. PATIENTS AND METHODS: Between 1992 and 2006, 21 patients (17 women and four men; mean age 32.1 years, SD 15.6) had endoscopic treatment for VUR (14 unilateral and seven bilateral ureteric units, UU). Patients previously operated for VUR were excluded. The VUR grades were II, III, IV and V in 10, 12, five and one UUs, respectively. The main indication for treatment was a history of repeated episodes of acute pyelonephritis (61%). Complications after surgery were evaluated. RESULTS: The success rate of the first endoscopic treatment was 69%, and was 81% after the second. Two UUs with grade IV VUR were endoscopically managed for a third time with complete resolution. Only one UU with grade V VUR required open surgery. The success rate for VUR grades II, III and IV after the first treatment was five of eight, 12/12 and one of five, respectively. After the second treatment the success rate increased to seven of eight and two of five for grades II and IV, respectively. There were no complications related to the intervention. Factors related to a failure of technique were duplex ureter and dysfunctional voiding in eight UUs (seven patients). CONCLUSIONS: The endoscopic management of VUR in previously untreated adult patients is a simple and efficient technique, with low comorbidity.

Hemangioma of the prostatic urethra: holmium laser treatment.

Urethral hemangiomas are benign vascular tumors that are found in perimontanal prostatic localization and less frequently in the urethra. Although different urethral procedures have been postulated for its treatment, the best results are achieved using lasers. A patient who underwent endoscopic holmium laser treatment for such hemangiomas is presented. Total disappearance of the lesions without any complications was achieved.