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Objective: This study aimed to determine local recurrence (LR) rate and pattern after transanal total mesorectal excision (TaTME) for rectal cancer. Background: TaTME for mid- and low rectal cancer has known a rapid and worldwide adoption. Recently, concerns have been raised on the oncological safety in light of reported high LR rates with a multifocal pattern. Methods: This was a multicenter observational cohort study in 6 tertiary referral centers. All consecutive TaTME cases for primary rectal adenocarcinoma from the first TaTME case in every center until December 2018 were included for analysis. Patients with benign tumors, malignancies other than adenocarcinoma and recurrent rectal cancer, as well as exenterative procedures, were excluded. The primary endpoint was 2-year LR rate. Secondary endpoints included patterns and treatment of LR and histopathological characteristics of the primary surgery. Results: A total of 767 patients were identified and eligible for analysis. Resection margins were involved in 8% and optimal pathological outcome (clear margins, (nearly) complete specimen, no perforation) was achieved in 86% of patients. After a median follow-up of 25.5 months, 24 patients developed LR, with an actuarial cumulative 2-year LR rate of 3% (95% CI 2-5). In none of the patients, a multifocal pattern of LR was observed. Thirteen patients had isolated LR (without systemic disease) and 10/13 could be managed by salvage surgery of whom 8 were disease-free at the end of follow-up. Conclusions and relevance: This study shows good loco regional control after TaTME in selected cases from tertiary referral centers and does not indicate an inherent oncological risk of the surgical technique. [ABSTRACT FROM AUTHOR]

Transanal total mesorectal excision can be a technically challenging operation to master. While many early adopters have reported adequate outcomes, others have failed to reproduce these results. There are contradicting data on oncologic outcomes during the learning phase of this technique. Thus, our objective was to perform a multicentered assessment of oncological outcomes in patients undergoing transanal total mesorectal excision during the learning phase in a sample of successful adopting centers. Surgeons from 8 centers with experience in the management of rectal cancer were invited to participate. The initial 51 consecutive benign and malignant cases of the participating units were retrospectively reviewed, but only 366 cancer cases were included in the analysis. Procedures were divided into implementation (ie, the first 10 cases) and postimplementation (ie, case 11 on onwards) groups, and the main outcome was the incidence of local recurrence. The overall prevalence of local recurrence was 4.1% at a median follow-up of 35 months (interquartile range 20.3–44.2); among implementation and postimplementation groups local recurrence was 7.5% and 3.1%, respectively, and the rate of local recurrence was observed to be nearly 60% lower in the postimplementation group (hazard ratio [95% confidence interval] = 0.43 [0.26–0.72]) Total mesorectal excision specimens were complete or nearly complete in 87.7% of cases, and the circumferential and distal margins were clear in 93.2% and 92.6%, respectively Local recurrence rate was low during the learning phase of the transanal total mesorectal excision in a sample of rectal cancer surgeons with acceptable surgical and oncologic outcomes. Both the prevalence and rate of local recurrence were markedly lower in the postimplementation phase, indicating improvement as experience accumulated. [ABSTRACT FROM AUTHOR]

Background: The wide global variation in the definition of the rectum has led to significant inconsistencies in trial recruitment, clinical management, and outcomes. Surgical technique and use of preoperative treatment for a cancer of the rectum and sigmoid colon are radically different and dependent on the local definitions employed by the clinical team. A consensus definition of the rectum is needed to standardise treatment. Methods: The consensus was conducted using the Delphi technique with multidisciplinary colorectal experts from October, 2017 to April, 2018. Results: Eleven different definitions for the rectum were used by participants in the consensus. Magnetic resonance imaging (MRI) was the most frequent modality used to define the rectum (67%), and the preferred modality for 72% of participants. The most agreed consensus landmark (56%) was ''the sigmoid take-off,'' an anatomic, image-based definition of the junction of the mes-orectum and mesocolon. In the second round, 81% of participants agreed that the sigmoid take-off as seen on computed tomography or MRI achieved consensus, and that it could be implemented in their institution. Also, 87% were satisfied with the sigmoid take-off as the consensus landmark. Conclusion: An international consensus definition for the rectum is the point of the sigmoid take-off as visualized on imaging. The sigmoid take-off can be identified as the mesocolon elongates as the ventral and horizontal course of the sigmoid on axial and sagittal views respectively on cross-sectional imaging. Routine application of this landmark during multidisciplinary team discussion for all patients will enable greater consistency in tumour localisation. [ABSTRACT FROM AUTHOR]

Background: Ustekinumab, a monoclonal antibody targeting interleukins-12 and -23 is used to treat adults with Crohn's disease [CD]. We determined the 30-day postoperative infectious complication rate among CD patients who received ustekinumab within the 12 weeks prior to an abdominal operation as compared with patients who received anti-tumor necrosis factor [TNF] agents. Methods: A retrospective chart review of adults with CD who underwent an abdominal operation between January 1, 2015 and May 1, 2017 was performed across six sites. Surgical site infection [SSI] was defined as superficial skin and soft tissue infection, intra-abdominal abscess, anastomotic leak, and mucocutaneous separation of the stoma. Results: Forty-four patients received ustekinumab and 169 patients received anti-TNF therapy within the 12 weeks prior to surgery. The two groups were similar, except anti-TNF patients were more likely to have received combination therapy with an immunomodulator [P = 0.006]. There were no significant differences in postoperative SSI [13% in ustekinumab versus 20% in anti TNFtreated patients, p = 0.61] or hospital readmission rates [18% versus 10%, respectively, p = 0.14], but ustekinumab-treated patients had a higher rate of return to the operating room [16% versus 5%; P = 0.01]. There were no significant predictors identified on multivariable analysis. Conclusions: Of the 44 patients with CD who received ustekinumab within the 12 weeks prior to a major abdominal operation, 13% experienced a 30-day postoperative SSI, not statistically different from the 20% found in the anti-TNF cohort. Ustekinumab treatment within 12 weeks of surgery does not appear to increase the risk of postoperative SSI above that of CD patients treated with anti-TNF medications. [ABSTRACT FROM AUTHOR]

Background and Aim: Transmural inflammation in Crohn's disease [CD] leads to stricturing or penetrating complications. Factors impacting on the need and timing of surgery in ileal stricturing CD [IS-CD] are understudied. Our aim was to identify risk factors in IS-CD associated with the need for surgery over time. Methods: All cross-sectional imaging [XSI] performed for CD between 2006 and 2015 in a tertiary referral centre was analysed. The electronic charts of patients with IS-CD were reviewed for demographic, clinical, biochemical, imaging, genetic, and endoscopic factors. An independent cohort was used for validation. Results: A total of 1803 XSI were performed in 957 patients with CD. IS-CD was diagnosed in 235 patients, and 161 of these [69%] needed surgery. Prestenotic dilation (hazard ratio [HR] 2.05, 95% confidence interval [CI] 1.22-3.45, p = 0.007], C-reactive protein at diagnosis of IS-CD > 11 mg/L [HR 1.53, 95% CI 1.05-2.24, p = 0.026], Montreal B3 phenotype [HR 1.58, 95% CI 1.06-2.36, p = 0.023], previous/current anti-tumour necrosis factor [TNF] exposure [HR 1.44, 95% CI 1.00-2.06, p = 0.048], and presence of at least one NOD2 rs2066844 risk allele [HR 1.51, 95% CI 1.02-2.23, p = 0.038] significantly impacted on the need for surgery in multivariate analysis.The risk stratification model [BACARDI] yielded a surgery-free survival after 5 years of 77%, 38%,19%, and 0% for the low, medium, high, and all risk groups, respectively. Based on an independent cohort of 27 patients, the results were validated and demonstrated adequate performance. Conclusions: This risk model can facilitate therapeutic decisions in IS-CD and suggest the correct time for surgery in daily clinical practice. [ABSTRACT FROM AUTHOR]

Aim: Ileocolonoscopy allows early detection of recurrence after surgical resection for Crohn's disease [CD]. Plexitis, defined as presence of inflammatory cells in or around enteric ganglia or nerve bundles, in the proximal surgical margin has been associated with an increased overall recurrence risk. We investigated prospectively whether plexitis can predict endoscopic recurrence [ER] in a consecutive cohort of CD patients undergoing ileocolonic resection. Methods: All CD patients undergoing ileocolonic resection in our institution between October 2009 and December 2012 were eligible for this study. Clinical data were obtained prospectively from the patients' files, and biopsies from the proximal surgical margins were analysed immunohistochemically for inflammation at the myenteric and submucosal plexus [lymphocytes, mast cells, eosinophils]. The degree of plexitis was correlated with the presence of ER at 6 months, defined as a modified Rutgeerts' score of = i2b. Multivariate models were developed and tested to predict posterior probability of ER. Results: A total of 74 patients were included. Six months after ileocolonic resection, 50% showed ER. Known risk factors such as penetrating disease, previous resections, and active smoking, showed no relation with ER. On the other hand, submucosal lymphocytic plexitis was associated with ER [p = 0.020]. The predictive value of lymphocytic cell count increased with more extensive biopsy sampling and with application of immunohistochemistry. Conclusions: Submucosal lymphocytic plexitis in the proximal surgical margin was significantly related with a higher risk for ER after ileocolonic resection. These data support development of a postoperative prevention trial with vedolizumab, which may block lymphocytic trafficking in the postoperative bowel. [ABSTRACT FROM AUTHOR]

The postoperative endoscopic recurrence score, commonly referred to as the Rutgeerts score, was designed to predict clinical recurrence risk in Crohn's disease (CD) patients undergoing ileocolonic resection based on early endoscopic findings at the anastomosis and in the neoterminal ileum.1 In the pivotal publication, the i2 category, including aphthous lesions in the terminal ileum as well as ileocolonic anastomosis lesions, had a heterogeneous recurrence risk. Because anastomotic ulcers were suspected to be postsurgical ischemic lesions and less predictive of progressive disease,2 a modified Rutgeerts score (mRS) was proposed: i2a, lesions confined to the anastomosis ±<5 isolated aphthous ulcers in the ileum; i2b, more than 5 aphthous ulcers in the ileum with normal mucosa in between, ± anastomotic lesions.3,4 [ABSTRACT FROM AUTHOR]

This ECCO topical review of the European Crohn's and Colitis Organisation [ECCO] focused on prediction, diagnosis, and management of fibrostenosing Crohn's disease [CD]. The objective was to achieve evidence-supported, expert consensus that provides guidance for clinical practice. [ABSTRACT FROM AUTHOR]

Objective: This multicenter study aims to assess long-term functional outcome, early and late (mesh-related) complications, and recurrences after laparoscopic ventral mesh rectopexy (LVR) for rectal prolapse syndromes in a large cohort of consecutive patients. Background: Long-term outcome data for prolapse repair are rare. A high incidence of mesh-related problems has been noted after transvaginal approaches using nonresorbable meshes. Methods: All patients treated with LVR at the Meander Medical Centre, Amersfoort, the Netherlands and the University Hospital Leuven, Belgium between January 1999 and March 2013 were enrolled in this study. All data were retrieved from a prospectively maintained database. Kaplan-Meier estimates were calculated for recurrences and mesh-related problems. Results: 919 consecutive patients (869 women; 50 men) underwent LVR. A 10-year recurrence rate of 8.2% (95% confidence interval, 3.7-12.7) for external rectal prolapse repair was noted. Mesh-related complications were recorded in 18 patients (4.6%), of which mesh erosion to the vagina occurred in 7 patients (1.3%). In 5 of these patients, LVR was combined with a perineotomy. Both rates of fecal incontinence and obstructed defecation decreased significantly (P < 0.0001) after LVR compared to the preoperative incidence (11.1% vs 37.5% for incontinence and 15.6% vs 54.0% for constipation). Conclusions: LVR is safe and effective for the treatment of different rectal prolapse syndromes. Long-term recurrence rates are in line with classic types of mesh rectopexy and occurrence of mesh-related complications is rare. [ABSTRACT FROM AUTHOR]

Background & Aims Infliximab is effective for patients with refractory ulcerative colitis (UC), but few factors have been identified that predict long-term outcome of therapy. We aimed to identify a panel of markers associated with outcome of infliximab therapy to help physicians make personalized treatment decisions. Methods We collected data from the first 285 patients with refractory UC (41% female; median age, 39 y) treated with infliximab before July 2012 at University Hospitals Leuven, in Belgium. We performed a Cox regression analysis to identify independent factors that predicted relapse-free and colectomy-free survival, and used these factors to create a panel of markers (risk panel). Results During a median follow-up period of 5 years, 61% of patients relapsed and 20% required colectomy. Independent predictors of relapse-free survival included short-term complete clinical response (odds ratio [OR], 3.75; 95% confidence interval [CI], 2.35–5.97; P < .001), mucosal healing (OR, 1.87; 95% CI, 1.17–2.98; P = .009), and absence of atypical perinuclear antineutrophil cytoplasmic antibodies (pANCA) (OR, 1.96; 95% CI, 1.23–3.12; P = .005). Independent predictors of colectomy-free survival included short-term clinical response (OR, 7.74; 95% CI, 2.76–21.68; P < .001), mucosal healing (OR, 4.02; 95% CI, 1.16–13.97; P = .028), baseline level of C-reactive protein (CRP) of 5 mg/L or less (OR, 2.95; 95% CI, 1.26–6.89; P = .012), and baseline level of albumin of 35 g/L or greater (OR, 3.03; 95% CI, 1.12–8.22; P = .029). Based on serologic analysis of a subgroup of 112 patients, levels of infliximab greater than 2.5 μg/mL at week 14 of treatment predicted relapse-free survival ( P < .001) and colectomy-free survival ( P = .034). A risk panel that included levels of pANCA, CRP, albumin, clinical response, and mucosal healing identified patients at risk for UC relapse or colectomy (both P < .001). Conclusions Clinical response and mucosal healing were confirmed as independent predictors of long-term outcome from infliximab therapy in patients with UC. We identified additional factors (levels of pANCA, CRP, and albumin) to create a risk panel that predicts long-term outcomes of therapy. Serum levels of infliximab at week 14 of treatment also were associated with patient outcomes. Our risk panel and short-term serum levels of infliximab therefore might be used to guide therapy. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Infliximab (IFX) has been shown efficacious for moderate-to-severe ulcerative colitis (UC), but data on long-term efficacy are lacking. We investigated long-term outcome including colectomy rates in outpatients treated with IFX for refractory UC in a single referral centre, and evaluated if predictors could be identified. Methods: The first 121 outpatients (median age 38.0 years) with refractory UC treated with IFX were included. The primary outcome was colectomy-free survival. Secondary measures were sustained clinical response and serious adverse events. Results: From the 81 patients (67%) with an initial clinical response to IFX, 68% had a sustained clinical response. No independent predictors of sustained clinical response could be identified. Over a median (IQR) follow-up period of 33.0 (17.0–49.8) months, 21 patients (17%) came to colectomy. Independent predictors of colectomy were absence of short-term clinical response [Hazard ratio 10.8 (95% CI 3.5–32.8), p <0.001], a baseline CRP level ≥5 mg/L [Hazard ratio 14.5 (95% CI 2.0–108.6), p =0.006] and previous IV treatment with corticosteroids and/or cyclosporine [Hazard ratio 2.4 (95% CI 1.1–5.9), p =0.033]. Six patients developed a serious infection, three a malignancy, two a post-operative complication and one patient died (suicide). Conclusions: With a median follow-up of 33.0 months after start of IFX, 17% of patients with refractory UC needed colectomy, while sustained clinical response was present in 68% of initial responders. [Copyright &y& Elsevier]

Abstract: Background and Aims : Pouchitis, the most common complication after proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis, has been attributed to altered composition of faecal flora. We investigated the role of antimicrobial and antiglycan antibodies and polymorphisms in microbial pattern recognition receptor genes. Methods : Clinical charts of all 184 patients with ulcerative colitis who underwent IPAA between 1990–2004 were reviewed for pre- and post-operative disease course. Results : Follow-up data were available in 172 patients [67 female, median age at proctocolectomy 39.1 years]. During a median follow-up of 6.7 (interquartile range 3.7–10.5) years, 80 patients (47%) developed at least one episode of pouchitis. Cox proportional-hazard regression identified extra-intestinal manifestations [HR 1.78 (95%CI 1.10–2.88), p =0.020], a GT/TT genotype at Toll-like-receptor-1 S87I [HR 1.64 (1.01–2.66), p =0.047], anti-chitobioside carbohydrate antibodies [HR 2.03 (1.11–3.70), p =0.021] and young age at diagnosis [p =0.003] to be independently associated with pouchitis. Factors associated with chronic pouchitis, diagnosed in 33 patients (19%), were extra-intestinal manifestations [HR 2.45 (1.07–5.62), p =0.034], backwash ileitis [HR 3.15 (1.10–9.00), p =0.032], outer-membrane porin antibodies [HR 2.67 (1.20–5.94), p =0.016] and young age at proctocolectomy [p =0.008]. Conclusions: : The reported association with antibodies and Toll-like-receptor-1 supports the pathophysiological role of the faecal flora in the development of pouchitis. [Copyright &y& Elsevier]

Complex high and recurrent fistulas remain a surgical challenge. Simple division, i.e., fistulotomy, will likely result in fecal incontinence. Various surgical treatment options for these fistulas have shown disappointing results. Recently a biologic anal fistula plug was developed to treat these high transsphincteric fistulas. To assess the results of the anal fistula plug in patients with complex high perianal fistulas, a prospective, two-center, clinical study was undertaken. Between April 2006 and October 2006, a consecutive series of patients with difficult therapy-resistant high fistulas were enrolled. During surgery, the internal fistula tract opening was identified. A conical shaped collagen plug was pulled through the fistula tract. Any remaining portion of the plug that was not implanted in the tract was removed. The plug was fixed at the internal opening with a deep 3/0 polydioxanone suture. Seventeen patients with a median age of 45 (range, 27–75) years were included. Of these patients, 71 percent (12/17) were male. At a median length of follow-up of 7 (range, 3–9) months, 7 of 17 fistulas had healed (41 percent). In ten patients, the fistula recurred. In these small series of 17 patients with difficult high perianal fistulas, a success rate of 41 percent is noted. Larger series, preferably in trial setting, must be performed to establish the efficacy of the anal fistula plug in perianal fistula. [ABSTRACT FROM AUTHOR]

Abstract: It remains unclear when to perform a discoid or segmental bowel resection for large endometriotic nodules with intestinal invasion. Moreover, endometriosis series are rather small to fully evaluate functional consequences of bowel resection. We therefore reviewed the incidence of leakage and functional problems after anterior and sigmoid resection as reported in the surgical literature albeit for other indications. Endoscopic resection clearly is feasible but requires an experienced surgeon. The incidence of leakage is not different after hand-sewn or stapled anastomosis, but is higher after a low rectum resection than after a sigmoid resection. Similarly, functional bowel problems are higher after a low rectum resection than after sigmoid resection. Low rectum resection in addition can be associated with functional bladder problems and sexual disturbances as anorgasmia. In conclusion, short- and long-term complications are much higher after a low rectum than after a sigmoid resection. This seems to be important in making the decision to perform a discoid or a segmental bowel resection for severe endometriosis. [Copyright &y& Elsevier]

Background & Aims: Early ileocolonoscopy allows detection of recurrence after surgically induced remission of Crohn’s disease (CD). Unequivocal histologic markers predicting recurrence have not been identified. We assessed the predictive value of neural lesions for early endoscopic CD recurrence and long-term reintervention risk. Methods: Ileocolonic resection specimens from 59 patients with CD and 21 control patients were histologically scored for typical inflammatory bowel disease lesions, neural hypertrophy, and presence and severity of inflamed ganglia and nerve bundles. Endoscopic recurrence was determined at 3 months in all patients and at 1 year in 32 patients as part of 2 prospective clinical trials. Results: Myenteric plexitis of the proximal resection margin was present in 32 patients with CD (54%) in absence of surrounding inflammation. Patients with this feature had a higher endoscopic recurrence (Rutgeerts score ≥2) at 3 months (75% vs 41%; odds ratio, 4.36; 95% confidence interval, 1.44–13.23; P = .008) and at 1 year (93% vs 59%; odds ratio, 9.80; 95% confidence interval, 1.04–92.70; P = .041) and had a trend toward an earlier reintervention (mean, 7.00 vs 5.30 years; P = .174). The severity of myenteric plexitis in the proximal resection margin correlated with the severity of endoscopic recurrence at 3 months (r = 0.334, P = .010) and 1 year (r = 0.560, P = .001). Myenteric plexitis was the only consistent predictor of endoscopic recurrence. Conclusions: The presence of myenteric plexitis in proximal margins of ileocolonic resection specimens is predictive of early endoscopic CD recurrence. [Copyright &y& Elsevier]

PURPOSE: Mechanical bowel preparation is common practice in elective colon surgery. In recent literature the value of this procedure is under discussion. To verify the value of mechanical bowel preparation in elective open colon surgery, a randomized clinical trial was conducted. METHODS: During a prospective, multicenter, randomized study, 250 patients undergoing elective open colon surgery were randomized between receiving mechanical bowel preparation with polyethylene glycol (PEG group, 125 patients) and having a normal meal preoperatively (normal meal preoperatively group, 125 patients). Outcome parameters were wound infection with bacterial results of intraoperative swabs and anastomotic leak. RESULTS: In the polyethylene glycol group there were a total of nine wound infections (7.2 percent) and seven anastomotic leaks (5.6 percent) compared with seven wound infections (5.6 percent) (P = 0.61) and six anastomotic leaks (4.8 percent) (P = 0.78) in the normal meal preoperatively group. Bacterial results showed 52 percent sterile subcutis swabs in the PEG group and 63 percent sterile subcutis swabs in the normal meal preoperatively group (P =0.11). CONCLUSION: In the present study we could not detect a difference in outcome parameters between patients receiving mechanical bowel preparation in elective open colon surgery and patients without preoperative treatment of the bowel. The present study, although underpowered, did not show a difference in the primary outcome of bacterial wound cultures between patients receiving preoperative mechanical bowel preparation and patients receiving no preoperative bowel treatment. We conclude that there may be no need to continue the use of mechanical bowel preparation in elective open colon surgery. [ABSTRACT FROM AUTHOR]

Background & Aims: Crohn’s disease almost inevitably recurs after ileocolonic resection, and effective prophylactic therapy has not been identified. We investigated the efficacy and safety of ornidazole, a nitroimidazole antibiotic, for the prevention of clinical recurrence of Crohn’s disease after curative ileocolonic resection in a placebo-controlled double-blind clinical trial. Methods: Eighty patients were randomized to ornidazole 1 g/day or placebo started within 1 week of resection and continued for 1 year. The primary end point was the proportion of patients with clinical recurrence at 1 year. Secondary end points were endoscopic recurrence at 3 months and 12 months after resection. Results: Two patients in the ornidazole group withdrew consent and were not dosed. Ornidazole significantly reduced the clinical recurrence rate at 1 year from 15 of 40 (37.5%) patients in the placebo group to 3 of 38 (7.9%) patients in the ornidazole group (Fisher exact test, 8.03; P = .0046; odds ratio, 0.14; 95% confidence interval, 0.037–0.546). Ornidazole reduced endoscopic recurrence at 12 months from 26 of 33 (79%) in the placebo group to 15 of 28 (53.6%) in the ornidazole group (χ2, 4.37; P = .037; odds ratio, 0.31; 95% confidence interval, 0.10–0.94). Endoscopic recurrence at 3 and 12 months predicted clinical recurrence. Significantly more patients in the ornidazole group dropped out from the study because of side effects (P = .041). Conclusions: Ornidazole 1 g/day is effective for the prevention of recurrence of Crohn’s disease after ileocolonic resection. [Copyright &y& Elsevier]

Vitamin D deficiency is common in Crohn's disease (CD). High-dose vitamin D had anti-inflammatory effects in preclinical studies and trials of patients with CD. We performed a randomized trial to determine whether high-dose vitamin D prevents postoperative recurrence of CD after ileocolonic resection. Patients with CD after ileocolonic resection with ileocolonic anastomosis were assigned randomly to groups given weekly 25,000 IU oral vitamin D (n = 72) or placebo (n = 71) for 26 weeks, at 17 hospitals in The Netherlands and Belgium, from February 2014 through June 2017. Patients were assessed at baseline and at weeks 2, 6, 12, and 26 for laboratory and clinical parameters, and underwent ileocolonoscopy at 26 weeks. The primary end point was endoscopic recurrence (modified Rutgeerts score, ≥i2b, as assessed by blinded readers) at 26 weeks. Secondary end points included clinical recurrence (Crohn's disease activity index, ≥220), quality of life (measured by the 36-Item Short Form Health Survey, Inflammatory Bowel Disease Questionnaire, and EuroQol, a 5-dimension questionnaire), and outcomes associated with the baseline serum concentration of vitamin D. In the vitamin D group, serum levels of 25-hydroxy vitamin D increased from a median of 42 nmol/L at baseline to 81 nmol/L at week 26 (P <.00001), whereas levels did not change significantly in the placebo group and remained unchanged at 43 nmol/L. In the intention-to-treat analysis, the proportion of patients with endoscopic recurrence at 26 weeks did not differ significantly between the vitamin D vs the placebo group (58% vs 66%; P =.37). The cumulative rate of clinical recurrence did not differ significantly between the groups (18.1% in the vitamin D group vs 18.3% in the placebo group; P =.91). Quality of life improved slightly over time in both groups, but did not differ significantly between groups (P =.07). There were few adverse events in either group. High-dose vitamin D, compared with placebo, did not reduce the incidence of postoperative endoscopic or clinical recurrence of CD in patients who underwent ileocolonic resection with ileocolonic anastomosis. ClinicalTrials.gov no: NCT02010762. [ABSTRACT FROM AUTHOR]

The Rutgeerts' scoring system is used to evaluate patients with Crohn's disease (CD) following ileocolic resection, based on endoscopic findings at the anastomosis and in the neoterminal ileum. We investigated rates of clinical and surgical recurrence of CD after surgery and effect of therapy modification based on post-operative endoscopic findings. We collected data from 365 adults with CD (20% with Rutgeerts' score i0, 10% with score i1, 49% with score i2, 12% with score i3, 9% with score i4) who underwent ileocolonoscopy within 12 months of ileocolic resection with anastomosis from 2000 through 2013 at 2 centers in Belgium and France. Patients were followed for 3 y or more after the ileocolonoscopy. Clinical post-operative recurrence (POR) was defined as occurrence of CD symptoms along with biologic, radiologic, and/or endoscopic features of disease activity; modified surgical POR was defined as either an endoscopic or surgical intervention. After a median follow-up time of 88 months, 48% of patients had clinical POR and 26% had modified surgical POR. Rates of survival without clinical POR or a modified surgical POR were lower in patients with Rutgeerts' scores of i2, i3, or i4 compared to patients with scores of i0 or i1 (P <.001 and P =.02). New immunosuppressant or biological therapy was initiated following endoscopy in 129/254 patients (51%) with Rutgeerts' score of i2, i3, or i4 vs 7/111 patients (6%) with scores of i0 or i1 (odds ratio for new therapy, 14.9; 95% CI, 7.1–36.8; P <.001). A modest decrease in risk of clinical POR was observed for patients with Rutgeerts scores of i3 or i4 after initiation of immunosuppressive or biological therapy based on endoscopic findings (Breslow P =.03), but this was not observed for patients with scores of i2 (Breslow P =.46). Use of immunosuppressants and tumor necrosis factor antagonists to treat patients with an asymptomatic endoscopic post-operative recurrence of CD did not reduce long-term risk of clinical recurrence in patients with Rutgeerts' scores of i2, but it had a small effect in patients with scores of i3 or i4. [ABSTRACT FROM AUTHOR]