3 research outputs found
C-reactive protein (CRP) trajectory as a predictor of anastomotic leakage after rectal cancer resection : a multicentre cohort study
AIM: This study aimed to identify whether CRPâtrajectory measurement, including increase in CRPâlevel of 50Â mg/l per day, is an accurate predictor of anastomotic leakage (AL) in patients undergoing resection for rectal cancer. METHODS: A prospective multicentre database was used. CRP was recorded on the first three postoperative days. Sensitivity, specificity, positive and negative predictive values, and area under the receiver operator characteristic (ROC) curve were used to analyse performances of CRPâtrajectory measurements between postoperative day (POD) 1â2, 2â3, 1â3 and between any two days. RESULTS: A total of 271 patients were included in the study. AL was observed in 12.5% (34/271). Increase in CRPâlevel of 50Â mg/l between POD 1â2Â had a negative predictive value of 0.92, specificity of 0.71 and sensitivity of 0.57. Changes in CRPâlevels between POD 2â3 were associated with a negative predictive value, specificity and sensitivity of 0.89, 0.93 and 0.26, respectively. Changes in CRPâlevels between POD 1â3Â showed a negative predictive value of 0.94, specificity of 0.76 and sensitivity of 0.65. In addition, 50Â mg/l changes between any two days showed a negative predictive value of 0.92, specificity of 0.66 and sensitivity of 0.62. The area under the ROC curve for all CRPâtrajectory measurements ranged from 0.593â0.700. CONCLUSION: The present study showed that CRPâtrajectory between postoperative days lacks predictive value to singularly rule out AL. Early and safe discharge in patients undergoing rectal surgery for adenocarcinoma cannot be guaranteed based on this parameter. High negative predictive values are mainly caused by the relatively low prevalence of AL
Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease
BACKGROUND & AIMS:
Therapies for perianal fistulas in patients with Crohn's disease are often ineffective in producing long-term healing. We performed a randomized placebo-controlled trial to determine the long-term efficacy and safety of a single local administration of allogeneic expanded adipose-derived stem cells (Cx601) in patients with Crohn's disease and perianal fistulas.
METHODS:
We performed a double-blind study at 49 hospitals in Europe and Israel, comprising 212 patients with Crohn's disease and treatment-refractory, draining, complex perianal fistulas. Patients were randomly assigned (1:1) to groups given a single local injection of 120 million Cx601 cells or placebo (control), in addition to the standard of care. Efficacy endpoints evaluated in the modified intention-to-treat population (randomly assigned, treated, and with 1 or more post-baseline efficacy assessment) at week 52 included combined remission (closure of all treated external openings draining at baseline with absence of collections >2 cm, confirmed by magnetic resonance imaging) and clinical remission (absence of draining fistulas).
RESULTS:
The study's primary endpoint, at week 24, was previously reported (combined remission in 51.5% of patients given Cx601 vs 35.6% of controls, for a difference of 15.8 percentage points; 97.5% confidence interval [CI] 0.5-31.2; P = .021). At week 52, a significantly greater proportion of patients given Cx601 achieved combined remission (56.3%) vs controls (38.6%) (a difference of 17.7 percentage points; 95% CI 4.2-31.2; P = .010), and clinical remission (59.2% vs 41.6% of controls, for a difference of 17.6 percentage points; 95% CI 4.1-31.1; P = .013). Safety was maintained throughout week 52; adverse events occurred in 76.7% of patients in the Cx601 group and 72.5% of patients in the control group.
CONCLUSION:
In a phase 3 trial of patients with Crohn's disease and treatment-refractory complex perianal fistulas, we found Cx601 to be safe and effective in closing external openings, compared with placebo, after 1 year. ClinicalTrials.gov no: NCT01541579
Risk factors for unfavourable postoperative outcome in patients with Crohn's disease undergoing right hemicolectomy or ileocaecal resection. An international audit by ESCP and S-ECCO
Aim: Patient- and disease-related factors, as well as operation technique, all have the potential to impact on postoperative outcome in Crohn's disease. The available evidence is based on small series and often displays conflicting results. The aim was to investigate the effect of preoperative and intra-operative risk factors on 30-day postoperative outcome in patients undergoing surgery for Crohn's disease. Method: This was an international prospective snapshot audit including consecutive patients undergoing right hemicolectomy or ileocaecal resection. The study analysed a subset of patients who underwent surgery for Crohn's disease. The primary outcome measure was the overall Clavien\u2013Dindo postoperative complication rate. The key secondary outcomes were anastomotic leak, reoperation, surgical site infection and length of stay in hospital. Multivariable binary logistic regression analyses were used to produce odds ratios and 95% confidence intervals. Results: In all, 375 resections in 375 patients were included. The median age was 37 and 57.1% were women. In multivariate analyses, postoperative complications were associated with preoperative parenteral nutrition (OR 2.36, 95% CI 1.10\u20134.97), urgent/expedited surgical intervention (OR 2.00, 95% CI 1.13\u20133.55) and unplanned intra-operative adverse events (OR 2.30, 95% CI 1.20\u20134.45). The postoperative length of stay in hospital was prolonged in patients who received preoperative parenteral nutrition (OR 31, 95% CI 1.08\u20131.61) and those who had urgent/expedited operations (OR 1.21, 95% CI 1.07\u20131.37). Conclusion: Preoperative parenteral nutritional support, urgent/expedited operation and unplanned intra-operative adverse events were associated with unfavourable postoperative outcome. Enhanced preoperative optimization and improved planning of operation pathways and timings may improve outcomes for patients