PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.

INTRODUCTION: The traditional double blind RCT is the 'gold standard' trial design. For a variety of reasons, these designs often fail to accrue enough participants to conclude. This is particularly challenging in localized prostate cancer. The cohort multiple randomised controlled trial (cmRCT) trial design may represent an alternative approach to delivering robust comparative data in prostate cancer. PATIENTS AND METHODS: IP3-PROSPECT is a cmRCT designed to test multiple prostate cancer interventions from eligible men in one cohort. Key to the design is two points of consent. First, at point of consent one, men referred for prostate cancer investigations are invited to join the cohort. They may then be randomly invited at a later date to consider an intervention at point of consent two. In the pilot phase we will test the acceptability and feasibility of developing the cohort. RESULTS: Acceptability and feasibility of the study will be measured by a combination of quantitative and qualitative methods. The primary outcome measure is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcome measures include the completeness of data collection at sites and return rates of patient questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT. CONCLUSION: The IP3-PROSPECT study will evaluate the cmRCT design in prostate cancer. Initially we will pilot the design, assessing for acceptability and feasibility. The cmRCT is an innovative design that offers potential for building a modern comparative evidence base for prostate cancer.

The fate of anastomotic sinuses after total mesorectal excision for rectal cancer.

OBJECTIVE: Chronic anastomotic sinus is a recognized complication of total mesorectal excision (TME) surgery. We observed two patients who developed new tumours within chronic anastomotic sinuses 6 and 19 years after initial surgery. The aim of this study was therefore to report the incidence and outcome of anastomotic sinuses, thus identifying those at potential risk of malignant change. METHOD: We retrospectively reviewed patient records and radiology reports to identify potentially curative rectal cancer cases between 1998 and 2005. RESULTS: In a consecutive series of 100 TMEs with ileostomy, there were 70 males and 30 females, aged 66 (33-88) years. Anastomosis was by double staple technique. A policy of instant enema was used prior to ileostomy closure. Eighty-six patients had instant enemas. Of the 14 that did not, four died prior to enema, one returned to theatre for sepsis, three had their anastomoses assessed by sigmoidoscopy alone. Six had incomplete records. Of the 86 patients, eight presacral sinuses were identified. Three sinuses closed spontaneously. Five persisted of whom two required further surgery. CONCLUSION: Persistent anastomotic sinuses occurred in 5% after curative TME. Malignant transformation can occur. Active treatment for chronic sinuses should, therefore, be considered.

Renal injury management in an urban trauma centre and implications for urological training.

INTRODUCTION: The aim of this study was to analyse the treatment and management of renal injury patients presenting to our major trauma unit to determine the likelihood of patients needing immediate nephrectomy. METHODS: The Trauma Audit and Research Network (TARN) database was used to review trauma cases presenting to our department between February 2009 and September 2013. Demographic data, mechanism and severity of injury, grade of renal trauma, management and 30-day outcome were determined from TARN data, electronic patient records and imaging. RESULTS: There were a total of 1,856 trauma cases, of which 36 patients (1.9%) had a renal injury. In this group, the median age was 28 years (range: 16-92 years), with 28 patients (78%) having blunt renal trauma and 8 (22%) penetrating renal trauma. The most common cause for blunt renal trauma was road traffic accidents. Renal trauma cases were stratified into American Association for the Surgery of Trauma (AAST) grades (grade I: 19%, grade II: 22%, grade III: 28%, grade IV: 28%, grade V: 0%). All patients with grade I and II injuries were treated conservatively. There were three patients (1 with grade III and 2 with grade IV renal injuries) who underwent radiological embolisation. One of these patients went on to have a delayed nephrectomy owing to unsuccessful embolisation. CONCLUSIONS: Trauma patients rarely require emergency nephrectomy. Radiological selective embolisation provides a good interventional option in cases of active bleeding from renal injury in haemodynamically stable patients. This has implications for trauma care and how surgical cover is provided for the rare event of nephrectomy.

Quantitative functional outcomes of the conservative management of partial segmental thrombosis of the corpus cavernosum.

The low incidence of partial segmental thrombosis of the corpus cavernosum (PSTCC) means its management is guided by isolated case reports. Erectile function is an important outcome that has not been described quantitatively in the literature. We present two cases of PSTCC managed conservatively. Although both patients reported resolution of local symptoms, formal analysis of sexual function at follow-up review has revealed that only one achieved complete recovery.