Nicholas P. McKenna

Postoperative outcomes in vedolizumab-treated Crohn's disease patients undergoing major abdominal operations

Up to 80% of patients with Crohns disease require an abdominal operation in their lifetime. As the use of vedolizumab is increasing for the treatment of Crohns disease, it is important to understand its potential association with post‐operative complications.

Postoperative Outcomes in Ustekinumab-Treated Patients Undergoing Abdominal Operations for Crohn’s Disease

BackgroundnUstekinumab, a monoclonal antibody targeting interleukins-12 and -23 is used to treat adults with Crohns 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.nnnMethodsnA 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.nnnResultsnForty-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 TNF-treated 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.nnnConclusionsnOf 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.

Systematic Review and Meta-Analysis: Preoperative Vedolizumab Treatment and Postoperative Complications in Patients with Inflammatory Bowel Disease

Background and AimsnThe impact of vedolizumab, a gut-selective monoclonal antibody, on postoperative outcomes is unclear. This study aimed to assess the impact of preoperative vedolizumab treatment on the rate of postoperative complications in patients with inflammatory bowel disease [IBD] undergoing abdominal surgery.nnnMethodsnA systematic search of multiple electronic databases from inception until May 2017 identified studies reporting rates of postoperative complications in vedolizumab-treated IBD patients compared to no biologic exposure or anti-tumor necrosis factor (anti-TNF) treated IBD patients. Outcomes of interest included postoperative infectious complications and overall postoperative complications. Pooled risk ratios and 95% confidence intervals were estimated using the random-effects model.nnnResultsnFive studies comprising 307 vedolizumab-treated IBD patients, 490 anti-TNF-treated IBD patients and 535 IBD patients not exposed to preoperative biologic therapy were included. The risk of postoperative infectious complications (risk ratio [RR] 0.99, 95% confidence interval [CI] 0.37-2.65) and overall postoperative complications [RR 1.00, 95% CI 0.46-2.15] were not significantly different between vedolizumab-treated patients and those who received no preoperative biologic therapy. In addition, the risk of postoperative infectious complications [RR 0.99, 95% CI 0.34-2.90] and overall postoperative complications [RR 0.92, 95% CI 0.44-1.92] were not significantly different between vedolizumab-treated vs anti-TNF-treated patients.nnnConclusionsnPreoperative vedolizumab treatment in IBD patients does not appear to be associated with an increased risk of postoperative infectious or overall postoperative complications compared to either preoperative anti-TNF therapy or no biologic therapy. Future prospective studies which include perioperative drug level monitoring are needed to confirm these findings.

Impact of BMI on Ability to Successfully Create an IPAA.

BACKGROUND:IPAA is the surgical treatment of choice for patients with ulcerative colitis. Limited data exist on how obesity impacts the ability of the surgeon to successfully create an IPAA. OBJECTIVE:We aimed to determine how BMI affects the ability to successfully complete the operation. DESIGN:This was a retrospective cohort study. SETTINGS:The study was conducted at a single tertiary care center. PATIENTS:We included all of the patients undergoing an IPAA for ulcerative colitis between January 2002 and August 2013 at our institution. A total of 1175 patients underwent proctocolectomy for ulcerative colitis during the study period; 129 were not offered IPAA (reasons included patient preference (n = 53), advanced age/comorbidity (n = 28), obesity (n = 23), incontinence (n = 8), suspicion of Crohn’s disease (n = 8), rectal cancer (n = 3), and other (n = 6)). Twenty-six patients had a concurrent cancer diagnosis, and 5 had a polyposis syndrome. MAIN OUTCOME MEASURES:We used logistic regression modeling to estimate the association between BMI and unsuccessful pouch attempts. RESULTS:Of the 1046 patients offered IPAA, 19 (1.82%) could not be technically completed at the time of surgery. Increasing BMI was associated with a higher risk of not being able to technically perform IPAA (OR = 1.26 (95% CI, 1.17–1.34)). The chance of an unsuccessful pouch rose from 2.0% at a BMI of 30 to 5.7% at a BMI of 35 and 15.0% at a BMI of 40 (p < 0.01). The area under the receiver operator characteristics curve was 0.82. BMI explained 21% of the variation in pouch success rate. LIMITATIONS:This study is limited in its generalizability. Also, the verbosity within the operative dictations varied among surgeons, making it impossible to be certain which maneuvers were performed to gain length in each patient. In addition, we were limited to BMI as a surrogate for visceral obesity, and we did not include medical therapy at the time of IPAA attempt. CONCLUSIONS:There is a strong association between increasing BMI and the ability to technically perform IPAA. Obese patients should be counseled to lose weight preoperatively to increase the probability of successful IPAA construction at the time of operation.

Analysis of postoperative venous thromboembolism in patients with chronic ulcerative colitis: Is it the disease or the operation?

BACKGROUND: Patients with IBD have a higher baseline risk of venous thromboembolism, which further increases with surgery. Therefore, extended venous thromboembolism chemoprophylaxis has been suggested in certain high-risk cohorts. OBJECTIVE: The purpose of this study was to determine whether the underlying diagnosis, operative procedure, or both influence the incidence of postoperative venous thromboembolism. DESIGN: This was a retrospective review. SETTINGS: The American College of Surgeons–National Surgical Quality Improvement Project database was analyzed. PATIENTS: The NSQIP database was queried for patients with chronic ulcerative colitis and non-IBD undergoing colorectal resections using surgical Current Procedural Terminology codes modeled after the 3 stages used for the surgical management of chronic ulcerative colitis from 2005 to 2013. MAIN OUTCOME MEASURES: We measured 30-day postoperative venous thromboembolism risk in patients with chronic ulcerative colitis based on operative stage and risk factors for development of venous thromboembolism. RESULTS: A total of 18,833 patients met inclusion criteria, with an overall rate of venous thromboembolism of 3.8. Among procedure risk groups, venous thromboembolism rates were high risk, 4.4%; intermediate risk, 1.6%; and low risk, 0.7% (across risk groups, p < 0.01). Emergent case subjects exhibited a higher rate of venous thromboembolism than their elective counterparts (6.9% vs 3.1%). Factors significantly associated with venous thromboembolism on adjusted analysis included emergent risk case (adjusted OR = 7.85), high-risk elective case (adjusted OR = 5.07), intermediate-risk elective case (adjusted OR = 2.69), steroid use (adjusted OR = 1.54), and preoperative albumin <3.5u2009g/dL (adjusted OR = 1.45). LIMITATIONS: Because of its retrospective nature, correlation between procedures and venous thromboembolism risk can be demonstrated, but causation cannot be proven. In addition, data on inpatient and extended venous thromboembolism prophylaxis use are not available. CONCLUSIONS: Emergent status and operative procedure are the 2 highest risk factors for postoperative venous thromboembolism. Extended venous thromboembolism prophylaxis might be appropriate for patients undergoing these high-risk procedures or any emergent colorectal procedures. See Video Abstract at http://links.lww.com/DCR/A339.

Thirty-Day Hospital Readmission After Restorative Proctocolectomy and Ileal Pouch Anal Anastomosis for Chronic Ulcerative Colitis at a High-Volume Center

BackgroundIleal pouch anal anastomosis (IPAA) is associated with a high 30-day hospital readmission rate. Risk factors and etiology of readmission remain poorly defined. We sought to determine the 30-day hospital readmission rate following IPAA at a high-volume center and identify any modifiable perioperative factors.MethodsA retrospective review of all patients undergoing two- or three-stage IPAA for chronic ulcerative colitis at our institution between 2002 and 2013 was performed. Analysis was performed on rate of readmission, readmission diagnosis, intervention performed upon readmission, and risk factors for readmission.ResultsThirty-day primary and secondary readmission rates after IPAA were 20.3% (nxa0=xa0185) and 2.1% (nxa0=xa019), respectively. The leading etiologies for readmission included partial small bowel obstruction/ileus (nxa0=xa052, 21.9%), pelvic sepsis (nxa0=xa043, 18.1%), dehydration (nxa0=xa042, 17.7%), and venous thromboembolism (nxa0=xa031, 13.1%). While the majority of readmissions were managed medically (nxa0=xa0119, 65.4%), 19.2% (nxa0=xa035) required radiologic intervention and 15.3% (nxa0=xa028) required a return to the operating room. On univariate analysis, younger age (pxa0=xa00.03) and female sex (pxa0=xa00.04) had a significantly increased risk of readmission. On multivariable analysis, BMI ≥xa030 (OR 0.51; 95% CI, 0.25–0.97, pxa0=xa00.04) was protective of readmission.ConclusionsThirty-day hospital readmission following IPAA remains a common problem. Preventable etiologies of readmission include dehydration and venous thromboembolism (VTE). Future quality improvement efforts should focus on education regarding stoma output and extended VTE prophylaxis to decrease hospital readmission rates following IPAA.

Vedolizumab and early postoperative complications in nonintestinal surgery: a case-matched analysis:

Background: Vedolizumab (VDZ) is a gut-specific α4-β7 integrin antagonist that has demonstrated efficacy in Crohn’s disease (CD) and ulcerative colitis (UC). The safety of VDZ in the perioperative period remains unclear. The aim of this study was to evaluate postoperative complications and perioperative safety in VDZ-treated patients undergoing nonintestinal operations. Methods: A case-matched study was performed at two inflammatory bowel disease (IBD) referral centers. Adult patients with CD and UC who underwent a nonintestinal surgical procedure during treatment with VDZ were included. Patients who had their last VDZ infusion up to 12 weeks before the procedure were considered exposed and were matched in a 1:1 ratio to patients without VDZ therapy, according to type of surgical procedure, age, and sex. The primary outcome was overall risk of early postoperative infectious complications (up to 30 days after surgery), readmissions, reoperations, surgical site infections, and other infections. The VDZ and control groups were subsequently compared using the Pearson χ2 test and Wilcoxon rank sum. Results: We identified 34 patients treated with VDZ who underwent 36 nonintestinal surgical procedures. These patients were matched with 36 control procedures. Postoperative complications were not different between the VDZ-treated and control cohorts for all outcomes analyzed: infectious complications occurred in 14% versus 8% (p = 0.45), superficial surgical site infections 6% versus 0% (p = 0.15), reoperations 6% versus 3% (p = 0.56) and readmissions 11% versus 6% (p = 0.37). Conclusions: VDZ-treated patients with IBD undergoing nonintestinal procedures did not have an increased risk of overall postoperative infections or other complications compared with matched controls.

Risk factors for readmission following ileal pouch–Anal anastomosis: an American College of Surgeons National Surgical Quality Improvement Program analysis

BACKGROUNDnThe purpose of this study was to identify preventable reasons for readmission and to delineate risk factors for readmission in the perioperative period for patients with chronic ulcerative colitis undergoing ileal pouch-anal anastomosis (IPAA).nnnMETHODSnPatients with a diagnosis of chronic ulcerative colitis undergoing either total proctocolectomy with IPAA or proctectomy with IPAA were identified in the American College of Surgeons National Surgical Quality Improvement Program database from 2012-2015. Unplanned 30-d readmissions were reviewed and categorized by reason for readmission. The unplanned readmission rate within 30xa0d was calculated by the person-days method. Multivariable Cox proportional hazard regression models determined independent risk factors for overall 30-d unplanned readmissions and readmissions sorted by primary readmission diagnosis.nnnRESULTSnThree thousand four hundred one patients had an IPAA performed during the study period. The overall unplanned readmission rate was 32.9% per 30 person-days. Leading diagnoses for unplanned readmission included infectious complications, dehydration, and venous thromboembolism (VTE). Multivariable analysis found Hispanic white and black/African American race/ethnicity (both versus non-Hispanic white) to be independently associated with unplanned 30-d readmission. Obesity, operative time 330+xa0min (versus <189xa0min), and Hispanic white race/ethnicity (versus non-Hispanic white) were associated with readmission for infectious complications. Age 57+ y (versus age 18-32 y) and hypertension requiring medication were associated with readmission for dehydration. Total proctocolectomy with IPAA (versus proctectomy with IPAA) was associated with readmission for VTE.nnnCONCLUSIONSnOne-third of patients undergoing IPAA experience an unplanned 30-d readmission. Infectious complications and dehydration account for most of the unplanned readmissions. Outpatient pathways to prevent dehydration and the use of extended VTE prophylaxis after two-stage IPAA may help reduce the rates of readmission following IPAA.

Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?

PURPOSEnThe purpose of this study was to determine if a laparoscopic approach reduces complications and length of stay (LOS) after total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA) in pediatric patients using a multicenter prospective database.nnnMETHODSnThe American College of Surgeons National Surgical Quality Improvement Project Pediatric database from 2012 to 2015 was used to identify patients with a diagnosis of chronic ulcerative colitis (CUC) or familial adenomatous polyposis (FAP) undergoing TPC-IPAA. Major complications, minor complications, and prolonged LOS were compared based on laparoscopic versus open approach.nnnRESULTSn195 (108 female) patients underwent TPC-IPAA at a median age of 14u202fyears (IQR: 11-16) for CUC (Nu202f=u202f99) or FAP (Nu202f=u202f96). Two-thirds of cases were laparoscopic. A laparoscopic approach was not associated with major complications, but lower odds of minor complications were observed. A reduced LOS was seen in laparoscopic versus open surgery (median LOS 6 vs 8u202fdays, pu202f<u202f0.01). Open IPAA was independently associated with prolonged LOS (>9u202fdays) in the FAP cohort (OR 4.0, 95% CI 1.1-14.0).nnnCONCLUSIONnA laparoscopic approach was not associated with increased major complications but was associated with lower odds of minor complications and shorter LOS. The laparoscopic approach should continue to be preferred for pouch procedures in pediatric patients.nnnTYPE OF STUDYnTreatment; retrospective study.nnnLEVEL OF EVIDENCEnLevel III.

Impact of sex on 30-day complications and long-term functional outcomes following ileal pouch-anal anastomosis for chronic ulcerative colitis

PurposeTo determine the impact of patient sex on operative characteristics, short-term complications, and long-term functional outcomes following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis (CUC).MethodsA retrospective review was performed on all patients undergoing two- or three-stage IPAA for CUC at our institution between January 2002 and August 2013. Patient demographics, operative characteristics, 30-day postoperative complications, and long-term functional outcomes from annual survey data were analyzed comparing men and women patients.ResultsDuring the study period, 911 IPAAs (542 men, 369 women) were performed. Men were older and were more often obese (both pu2009<xa00.01). Use of a three-stage approach and laparoscopic approach were similar between men and women, but operation length, intraoperative blood loss, and hospital length of stay were all higher in men (all pu2009<u20090.05). At 30xa0days, women had increased rates of superficial surgical site infections and urinary tract infections (both pu2009<u20090.05), while men had increased rates of urinary retention (pu2009=u20090.03). Five hundred forty-six patients (60%; 307 men, 239 women) responded to the annual post IPAA survey with a median follow-up of 5.1 and 5.0xa0years in men and women, respectively. Women reported increased frequency of daytime stools in the early follow-up period, but this difference resolved with time. Other functional outcomes were similar.ConclusionPatient sex impacts intraoperative complexity, postoperative length of stay, 30-day postoperative outcomes, and initial long-term function. These findings underscore the need to adjust preoperative counseling regarding IPAA outcomes based on sex.