Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271).

BACKGROUND: There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD. METHODS/DESIGN: This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn's disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6 months and functional results as well as quality of life at 12 months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12 months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12 months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity. DISCUSSION: The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD. TRIAL REGISTRATION: ClinicalTrial.gov: NCT03872271, date of registration March 13th, 2019.

Health as an independent predictor of the 2017 French presidential voting behaviour: a cross-sectional analysis.

BACKGROUND: It has been suggested that poor health has influenced vote for Brexit and the US presidential election. No such research has been published regarding the 2017 French presidential election. METHODS: We performed a cross-sectional analysis using a comprehensive set of socioeconomic and health indicators, to be compared with voting outcome at the first round of the 2017 French presidential election. The 95 French departments were selected as the unit of analysis. Data were obtained from publicly available sources. The linear model was used for both univariate and multivariate analysis to investigate the relation between voting patterns and predictors. Sensitivity analyses were done using the elastic-net regularisation. RESULTS: Emmanuel Macron and Marine Le Pen arrived ahead. When projected on the first factorial plane (~ 60% of the total inertia), Emmanuel Macron and Marine Le Pen tended to be in opposite directions regarding both socioeconomic and health factors. In the respective multivariate analyses of the two candidates, both socio-economic and health variables were significantly associated with voting patterns, with wealthier and healthier departments more likely to vote for Emmanuel Macron, and opposite departments more likely to vote for Marine Le Pen. Mortality (p = 0.03), severe chronic conditions (p = 0.014), and diabetes mellitus (p < 0.0001) were among the strongest predictors of voting pattern for Marine Le Pen. Sensitivity analyses did not substantially change those findings. CONCLUSIONS: We found that areas associated with poorer health status were significantly more likely to vote for the far-right candidate at the French presidential election, even after adjustment on socioeconomic criteria.

Postoperative Peritonitis After Digestive Tract Surgery: Surgical Management and Risk Factors for Morbidity and Mortality, a Cohort of 191 Patients.

BACKGROUND: Postoperative peritonitis (POP) following gastrointestinal surgery is associated with significant morbidity and mortality, with no clear management option proposed. The aim of this study was to report our surgical management of POP and identify pre- and perioperative risk factors for morbidity and mortality. METHODS: All patients with POP undergoing relaparotomy in our department between January 2004 and December 2013 were included. Pre- and perioperative data were analyzed to identify predictors of morbidity and mortality. RESULTS: A total of 191 patients required relaparotomy for POP, of which 16.8% required >1 reinterventions. The commonest cause of POP was anastomotic leakage (66.5%) followed by perforation (20.9%). POP was mostly treated by anastomotic takedown (51.8%), suture with derivative stoma (11.5%), enteral resection and stoma (12%), drainage of the leak (8.9%), stoma on perforation (8.4%), duodenal intubation (7.3%) or intubation of the leak (3.1%). The overall mortality rate was 14%, of which 40% died within the first 48 h. Major complications (Dindo-Clavien > 2) were seen in 47% of the cohort. Stoma formation occurred in 81.6% of patients following relaparotomy. Independent risk factors for mortality were: ASA > 2 (OR = 2.75, 95% CI = 1.07-7.62, p = 0.037), multiorgan failure (MOF) (OR = 5.22, 95% CI = 2.11-13.5, p = 0.0037), perioperative transfusion (OR = 2.7, 95% CI = 1.05-7.47, p = 0.04) and upper GI origin (OR = 3.55, 95% CI = 1.32-9.56, p = 0.013). Independent risk factors for morbidity were: MOF (OR = 2.74, 95% CI = 1.26-6.19, p = 0.013), upper GI origin (OR = 3.74, 95% CI = 1.59-9.44, p = 0.0034) and delayed extubation (OR = 0.27, 95% CI = 0.14-0.55, p = 0.0027). CONCLUSION: Mortality following POP remains a significant issue; however, it is decreasing due to effective and aggressive surgical intervention. Predictors of poor outcomes will help tailor management options.

Hospital Readmissions After Urological Surgical Procedures in France: A Nationwide Cohort Study over 3 Years.

BACKGROUND: Identifying the predictive factors for hospital readmission is required to target preventive measures. OBJECTIVE: To assess the rate of surgical readmissions after a urological procedure and the risk factors associated with readmission. DESIGN, SETTING, AND PARTICIPANTS: Data from all hospitalizations between January 2010 and November 2012 in France, regarding planned urological surgeries, were retrieved from the national medical database. To limit interactions between recent hospitalizations and surgical interventions, we selected only patients who were not hospitalized during the 12 mo preceding the urological procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome was the rate of readmissions within 30 d after urological surgery. The following risk factors for readmission were assessed: sex, age, diagnosis-related group, length of stay of initial hospitalization, type of hospitalization (conventional or day surgery), hospital volume activity, hospital volume for day surgery, and hospital status. Logistic regression multivariate analysis was used to assess risk factors. RESULTS AND LIMITATIONS: Overall, 419 787 patients were included among whom 77 241 patients (18.40%) were readmitted within the following 30 d. After multivariate analyses, male sex (odds ratio [OR]=1.84, confidence interval [CI] 95%: 1.81-1.88), high level of comorbidity (diagnosis-related group 3-4 vs 1-2: OR=2.14, CI 95%: 2.10-2.21), and initial management in a private hospital (private vs university hospital: OR=1.13, CI 95%: 1.11-1.16; private vs public general hospital: OR=1.21, CI 95%: 1.18-1.23) were associated with a higher risk of readmission within 30 d. CONCLUSIONS: Reported readmission rate within 30 d after a planned a urological procedure was nearly 20%. PATIENT SUMMARY: In this French national study, we investigated the readmission rate within 30 d after a planned urological procedure in a large French population and discovered it was nearly 20%.

Does a Combination of Laparoscopic Approach and Full Fast Track Multimodal Management Decrease Postoperative Morbidity?: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to assess whether association of laparoscopic approach and full fast track multimodal (FFT) management can reduce postoperative morbidity after colorectal cancer surgery, as compared to laparoscopic approach with limited fast-track program (LFT). SUMMARY OF BACKGROUND DATA: Recent advances in colorectal cancer surgery are introduction of laparoscopy and FFT implementation. METHODS: Patients eligible for elective laparoscopic colorectal cancer surgery were randomized into 2 groups: FFT or LFT care (with only early oral intake and mobilization starting on Day 1). Primary outcome was postoperative 30-day morbidity, according to Clavien-Dindo classification. RESULTS: Two hundred seventy patients were randomized and 263 were analyzed: 130 in FFT group and 133 in LFT group, including 106 colon (FFT: n = 52 and LFT: n = 54) and 157 rectal cancer (FFT: n = 78 and LFT: n = 79). Postoperative 30-day mortality was nil. Overall postoperative 30-day morbidity did not show any difference between the groups (FFT: 35% vs LFT: 29%, P = 0.290), neither regarding the overall population, nor in the colon (FFT: 23% vs LFT: 19%, P = 0.636) or rectal (FFT: 44% vs LFT: 35%, P = 0.330) cancer subgroups. Severe postoperative morbidity was also not different between groups (FFT: 12% vs LFT: 8%, P = 0.266). After multivariate regression analysis, only early intravenous catheter removal (on day 2) [odds ratio: 0.390; 95% confidence interval: (95% CI 0.181-0.842); P = 0.017] and the absence of intraoperative lidocaine intravenous perfusion (odds ratio: 0.182, 95% CI 0.042-0.788; P = 0.019) were identified as independent predictive factors of reduced postoperative morbidity. CONCLUSION: Addition of FFT multimodal management to laparoscopic approach with early oral intake and mobilization does not reduce postoperative morbidity after colorectal cancer surgery.

Comprehensive assessment of variation at the transforming growth factor beta type 1 receptor locus and colorectal cancer predisposition.

The role of transforming growth factor beta receptor type 1 (TGFBR1) polymorphisms, particularly a coding CGC insertion (rs11466445, TGFBR1*6A/9A) in exon 1, has been extensively investigated in regard to colorectal cancer (CRC) risk. These investigations have generated conflicting results. More recently, allele-specific expression (ASE) of TGFBR1 mRNA has been suggested as predisposing to CRC, with a relative risk of nearly 10-fold and a population attributable risk of approximately 10%. Owing to the potential importance of TGFBR1 variants in CRC, we performed a comprehensive examination of tagging SNPs at and around the gene in 3,101 CRC cases and 3,334 controls of northern European ancestry. To test whether rare or subpolymorphic TGFBR1 variants were associated with CRC risk, we sequenced the gene's exons in a subset of patients. We also evaluated TGFBR1 ASE in a panel of CRC cases and controls. Overall, we found no association between TGFBR1 polymorphisms and CRC risk. The rare variant screen did not identify any changes of potentially pathogenic effects. No evidence of greater ASE in cases than controls was detected, and no haplotype around TGFBR1 could account for the ASE reported in other studies. We conclude that neither genetic variation nor ASE at TGFBR1 is likely to be a major CRC risk factor.