Towards Response ADAptive Radiotherapy for organ preservation for intermediate-risk rectal cancer (preRADAR): protocol of a phase I dose-escalation trial

Introduction Organ preservation is associated with superior functional outcome and quality of life (QoL) compared with total mesorectal excision (TME) for rectal cancer. Only 10% of patients are eligible for organ preservation following short-course radiotherapy (SCRT, 25 Gy in five fractions) and a prolonged interval (4–8 weeks) to response evaluation. The organ preservation rate could potentially be increased by dose-escalated radiotherapy. Online adaptive magnetic resonance-guided radiotherapy (MRgRT) is anticipated to reduce radiation-induced toxicity and enable radiotherapy dose escalation. This trial aims to establish the maximum tolerated dose (MTD) of dose-escalated SCRT using online adaptive MRgRT.Methods and analysis The preRADAR is a multicentre phase I trial with a 6+3 dose-escalation design. Patients with intermediate-risk rectal cancer (cT3c-d(MRF-)N1M0 or cT1-3(MRF-)N1M0) interested in organ preservation are eligible. Patients are treated with a radiotherapy boost of 2×5 Gy (level 0), 3×5 Gy (level 1), 4×5 Gy (level 2) or 5×5 Gy (level 3) on the gross tumour volume in the week following standard SCRT using online adaptive MRgRT. The trial starts on dose level 1. The primary endpoint is the MTD based on the incidence of dose-limiting toxicity (DLT) per dose level. DLT is a composite of maximum one in nine severe radiation-induced toxicities and maximum one in three severe postoperative complications, in patients treated with TME or local excision within 26 weeks following start of treatment. Secondary endpoints include the organ preservation rate, non-DLT, oncological outcomes, patient-reported QoL and functional outcomes up to 2 years following start of treatment. Imaging and laboratory biomarkers are explored for early response prediction.Ethics and dissemination The trial protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht. The primary and secondary trial results will be published in international peer-reviewed journals.Biological, physical and clinical aspects of cancer treatment with ionising radiatio

[Ileo-anal pouch for inflammatory intestinal disease]

Item does not contain fulltext- The surgical treatment of choice for ulcerative colitis is colectomy followed by ileostomy or the construction of an ileo-anal pouch, which results in an improvement in quality of life.- The pouch can be constructed in one operation after a total colectomy or in two steps: first, constructing an ileostomy after a subtotal colectomy and second, constructing the pouch after a proctectomy. - The most common pouch-related diseases include surgical complications such as abscesses, fistulas and leaks, and inflammatory complications like pouchitis, cuffitis and Crohn's disease of the pouch.- The most important diagnostic tool to differentiate between the often difficult to distinguish pouch-related diseases is a pouchoscopy. - There are no evidence-based treatment strategies for pouch-related diseases due to the lack of large randomized placebo-controlled trials. - Pouch-related diseases can lead to pouch failure which may require surgical reintervention with revision or excision of the pouch

Stages and evaluation of surgical innovation: a clinical example of the ileo neorectal anastomosis after ulcerative colitis and familial adenomatous polyposis

Item does not contain fulltextAIM: So far, not many clinical examples that follow the IDEAL (Idea, Development, Evaluation, Assessment, and Long-term study) recommendations for evaluating and reporting surgical innovation and adoption are available. METHODS: In this article, all IDEAL stages will be described for a recent surgical innovation, the ileo neorectal anastomosis (INRA), a procedure restoring intestinal continuity after colectomy. RESULTS: INRA showed that the technique of small-bowel transposition with a vascular pedicle is feasible, with good long-term results. From the patient's point of view, no distinct advantage for INRA was found, with morbidity and functional results being in range with the gold standard ileal pouch anal anastomosis. CONCLUSION: The adoption of the IDEAL recommendations-that is, by performing evidence-based surgical studies-will improve surgical science, with the consequence that progress in surgical care continues and interventions become safer and more efficient and allow a better quality of life in surgical patients

Quality of life and health status before and after ileal pouch-anal anastomosis for ulcerative colitis.

BACKGROUND: Ileal pouch-anal anastomosis (IPAA) is considered the surgical treatment of choice for patients with ulcerative colitis. Quality of life (QoL) and health status are the most important patient-related outcomes. Studies investigating QoL are often cross-sectional and focus on health status. This longitudinal study evaluated QoL and health status after IPAA for ulcerative colitis and compared these with reference data from a healthy population. METHODS: Patients with ulcerative colitis who underwent a pouch operation between 2003 and 2008 completed validated questionnaires for QoL and health status. Questionnaires were completed before pouch surgery, and 6, 12, 24 and 36 months after operation. The effect of IPAA on QoL and health status was analysed, and data were compared with reference values from the healthy Dutch population. RESULTS: Data were obtained for 30 of the 32 patients. Six months after IPAA, QoL was at least comparable with that of the reference population in four of six domains. Twelve months after IPAA, overall QoL had improved, supported by findings in three QoL domains. Six months after IPAA, health status was comparable to that of the reference population in three of eight dimensions, and after 3 years it was at least comparable in five dimensions. CONCLUSION: QoL and health status increased after IPAA and reached levels comparable with those of the healthy reference population in a majority of domains and dimensions. QoL was restored first after IPAA, followed by health status

Reconstruction of the common femoral vein and artery after resection of a leiomyosarcoma of the CFV

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Open versus laparoscopic (assisted) ileo pouch anal anastomosis for ulcerative colitis and familial adenomatous polyposis.

BACKGROUND: Restorative proctocolectomy with ileo pouch anal anastomosis (IPAA) is the main surgical treatment for patients with ulcerative colitis (UC) and familial adenomatous polyposis (FAP). With the advancements of minimal-invasive surgery this demanding operation is increasingly being performed laparoscopically. Therefore, the presumed benefits of the laparoscopic approach need to be systematically evaluated. OBJECTIVES: To compare the beneficial and harmful effects of laparoscopic versus open IPAA for patients with UC and FAP. SEARCH STRATEGY: We searched The Cochrane IBD/FBD Group Specialized Trial Register (April 2007), The Cochrane Library (Issue 1, 2007), MEDLINE (1990 to April 2007), EMBASE (1990 to April 2007), ISI Web of Knowledge (1990 to April 2007) and the web casts of the American Society of Colon and Rectal Surgeons (ASCRS) (up to 2006) for all trials comparing open versus laparoscopic IPAA. SELECTION CRITERIA: All trials in patients with UC or FAP comparing any kind of laparoscopic IPAA versus open IPAA. No language limitations were applied. DATA COLLECTION AND ANALYSIS: Two authors independently performed selection of trials and data extraction. The methodological quality of all included trials was evaluated to assess bias risk. Analysis of RCTs and non-RCTs was performed separately. Analyses were based on the intention-to-treat principle. Authors were requested additional information in case of missing data. Sensitivity and subgroup analyses were performed if appropriate. MAIN Results : Eleven trials included 607 patients of whom 253 (41%) in the laparoscopic IPAA group. Only one of the included trials was a randomised controlled trial. There were no significant differences in mortality or complications between the two groups. Reoperation and readmission rates were not significantly different. Operative time was significantly longer in the laparoscopic group both in the RCT and meta-analysis of non-RCTs (weighted mean difference (WMD) 91 minutes; 95% Confidence Interval (CI) 53 to 130). There were no significant differences between the two groups regarding postoperative recovery parameters. Total incision length was significantly shorter in the laparoscopic group, while two trials evaluating cosmesis found significantly higher cosmesis scores in the laparoscopic group. Other long-term outcomes were poorly reported. AUTHORS' CONCLUSIONS: The laparoscopic IPAA is a feasible and safe procedure. Short-term advantages of the laparoscopic approach seem to be limited and their clinical significance is arguable. Large high-quality trials focusing on differences regarding specific postoperative complications, cosmesis, quality of life and costs are needed

The ileo neo rectal anastomosis: long-term results of surgical innovation in patients after ulcerative colitis and familial adenomatous polyposis

Contains fulltext : 117801.pdf (publisher's version ) (Closed access)PURPOSE: Restorative proctocolectomy with ileo neo rectal anastomosis (INRA) combines cure of ulcerative colitis (UC) or familial adenomatous polyposis (FAP) with restoration of intestinal continuity. Evaluation of long-term results was needed to determine if there is a place for INRA in the armamentarium of a surgeon besides the ileal pouch anal anastomosis (IPAA). METHODS: All patients with INRA were included in the analysis. Patient demographics and clinical and follow-up data (morbidity, dietary problems, defecation frequency, fecal continence, anal and neorectal physiology, and neorectal mucosa assessment) were registered prospectively. RESULTS: Seventy-nine patients were enrolled, and in 58 patients (50 UC, 8 FAP), INRA was successful. In 21 patients, intraoperative conversion to IPAA was needed. In 49 patients with INRA, a functional reservoir was achieved. No pelvic sepsis or bladder or sexual dysfunction occurred. Thirteen patients experienced episodes of reservoir inflammation. Median bowel movements of six (5, 8) with a nocturnal defecation frequency of one were recorded with fecal continence or minor incontinence. Anal manometry and neorectal physiology showed a decrease in resting pressure and an increase in squeeze pressure and maximum tolerated volume. The median follow-up was 8.1 years (6.7, 10.1). CONCLUSIONS: This is an example of a surgical innovation with a theoretical potential to be superior to the current technique. This potential was not confirmed in short- and long-term evaluations. Hence, IPAA is currently the best available alternative to a conventional ileostomy