Postoperative Outcomes in Vedolizumab-Treated Patients Undergoing Major Abdominal Operations for Inflammatory Bowel Disease: Retrospective Multicenter Cohort Study
Purpose. Multimodal analgesia is an essential component of an enhanced recovery pathway (ERP). An ERP that includes the use of single-injection intrathecal analgesia (IA) has been shown to decrease morbidity and cost and shorten length of stay (LOS). Limited data exist on safety, feasibility, and the optimal IA regimen. Our objective was to characterize the efficacy, safety, and feasibility of IA within an ERP in a cohort of colorectal surgical patients. Methods. We performed a retrospective review of all consecutive patients aged ≥ 18 years who underwent open or minimally invasive colorectal surgery from October 2012 to December 2013. All patients were enrolled in an institutional ERP that included the use of single-injection IA. Demographics, anesthetic management, efficacy (pain scores and opiate consumption), postoperative ileus (POI), adverse effects, and LOS are reported. Results. 601 patients were identified. The majority received opioid-only IA (91%) rather than a multimodal regimen. Median LOS was 3 days. Overall rate of ileus was 16%. Median pain scores at 4, 8, 16, 24, and 48 hours were 3, 2, 3, 4, and 3, respectively. There was no difference in postoperative pain scores, LOS, or POI based on intrathecal medication or dose received. Overall, development of respiratory depression (0.2%) or pruritus (1.2%) was rare. One patient required blood patch for postdural headache. Conclusion. Intrathecal analgesia is safe, feasible, and efficacious in the setting of ERP for colorectal surgery. All regimens and doses achieved a short LOS, low pain scores, and a low incidence of POI. This trial is registered with Clinicaltrails.gov NCT03411109.
Postoperative outcomes in vedolizumab‐treated Crohn's disease patients undergoing major abdominal operations
SummaryBackgroundUp to 80% of patients with Crohn's disease require an abdominal operation in their lifetime. As the use of vedolizumab is increasing for the treatment of Crohn's disease, it is important to understand its potential association with post‐operative complications.AimWe sought to compare 30‐day postoperative infectious complication rate among vedolizumab‐treated Crohn's disease patients vs those who had received TNFα inhibitors or no biologic therapy.MethodsA retrospective review of all Crohn's disease patients who received vedolizumab within 12 weeks of a major abdominal or pelvic operation was performed. Two control cohorts consisted of Crohn's disease patients treated with TNFα inhibitors or no biologic therapy.ResultsOne hundred Crohn's disease patients received vedolizumab within 12 weeks of an abdominal operation. Vedolizumab‐treated patients underwent an equivalent rate of laparoscopic surgery (P = .25), had fewer anastomoses performed (P = .0002), and had equally frequent diversion in the setting of anastomoses (P = .47). Thirty‐two vedolizumab‐treated patients experienced postoperative infectious complications (32%), 26 of which were surgical site infections (26%). The vedolizumab‐treated group experienced no difference in nonsurgical site infections (6% vs 5% anti‐TNFα and 2% nonbiologic; P = .34), but significantly higher rates of surgical site infections (26% vs 8% and 11%; P < .001). On univariate and multivariate analysis, exposure to vedolizumab remained a significant predictor of postoperative surgical site infection (P < .001 and P = .002).ConclusionsTwenty‐six per cent of Crohn's disease patients who received vedolizumab within 12 weeks prior to a major abdominal operation experienced a 30‐day postoperative surgical site infection, significantly higher than that of patients receiving TNFα inhibitors or no biologic therapy. Vedolizumab within 12 weeks of surgery remained a predictor of 30‐day postoperative surgical site infection on multivariable analysis. While vedolizumab‐treated Crohn's disease patients may be a sicker cohort of patients, it is important to consider these findings with regard to preoperative counselling, operative timing and primary closure of wounds.
Postoperative Outcomes in Ustekinumab-Treated Patients Undergoing Abdominal Operations for Crohn’s Disease
BACKGROUND: After IPAA, 8% of patients with ulcerative colitis are later diagnosed with Crohn’s disease of the pouch, associated with an increased rate of pouch failure. No study has reported on how often the clinical diagnosis is correlated with histologic findings of Crohn’s disease in the excised pouch. OBJECTIVE: The purpose of this study was to determine whether the clinical diagnosis is consistent with pathologic confirmation at pouch excision. SETTINGS: The study was conducted at a tertiary IBD referral center. PATIENTS: Patients with chronic ulcerative colitis who underwent pouch excision for presumed Crohn’s disease of the pouch were included. MAIN OUTCOME MEASURES: Preoperative evaluation and pathologic variables at the time of pouch excision were measured. RESULTS: A total of 35 patients underwent pouch excision for Crohn’s disease of the pouch based on a combination of clinical, radiographic, and endoscopic findings. Seven (20%) had surgical pathology consistent with Crohn’s disease at pouch excision. There were no differences in those 7 patients and the remaining 28 in terms of diagnosis at colectomy, primary pouch symptoms, prepouch inflammation, ulceration, or granulomas at endoscopy. In the nonpathology-confirmed Crohn’s disease, 40% (n = 11) had an anastomotic leak at time of IPAA versus 0% in the Crohn’s disease group, and 86% (n = 24) had symptoms of pouch dysfunction within 5 months of ileostomy reversal versus 13 months in the Crohn’s disease group. Of 28 without pathology-confirmed Crohn’s disease, 100% (n = 28) were treated with antibiotics, 68% (n = 19) with steroids, 59% (n = 16) with immunomodulators, and 57% (n = 15) with biologic therapy for Crohn’s disease of the pouch. LIMITATIONS: The study was limited by its single-center scope and lack of an established definition for Crohn’s disease of the pouch. CONCLUSIONS: Pathologic confirmation of Crohn’s disease was given to only one fifth of patients who underwent pouch excision for Crohn’s disease of the pouch. Given the histologic variability in Crohn’s disease, it may be unreasonable to expect histologic confirmation in every case; still, the diagnosis of Crohn’s disease of the pouch may be overly ascribed, resulting in unnecessary immunosuppressive medications and exclusion from consideration for pouch reconstructive surgery. See Video Abstract at http://links.lww.com/DCRA432.
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 <3.5 g/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.
AbstractAimRestorative proctocolectomy with ileal‐pouch anal anastomosis is the procedure of choice for ulcerative colitis. Unfortunately, up to 10% of pouches will fail, requiring either reconstruction or excision. While several series have reported on the aetiology of pouch failure, no study to date has focused on the postoperative complications associated with pouch excision.MethodsPatients who had excision of ileoanal reservoir with ileostomy (CPT code 45136) were included. Data abstracted included preoperative, operative and postoperative variables. A Kaplan–Meier curve of pouch survival was performed.ResultsIn all, 147 patients met the inclusion criteria for the study. The median age of patients was 47 years (73 women), and 132 had a diagnosis of ulcerative colitis at the time of colectomy. The most common indications for pouch excision were sepsis (n = 46; 31%) and Crohn's disease (n = 37; 25%). 84 (57%) patients experienced short‐term (< 30 days) postoperative complications, the most common of which was a surgical site infection (n = 32; 21%); 55 (37%) patients had long‐term complications (> 30 days) postoperatively, the most common of which was a return to the operating room (n = 19; 13%) largely for perineal wounds. Thirty‐day mortality was zero. 4.8%, 47.6%, 65.3% and 84.4% of patients had undergone pouch excision by 1, 5, 10 and 20 years from the time of pouch construction, respectively.ConclusionsPouch excision has a high rate of both short‐ and long‐term postoperative complications. Patients should be appropriately counselled to set expectations accordingly. In view of these findings we suggest that this operation should ideally be performed at a high volume centre with the availability of a multidisciplinary surgical team.
Long-standing Crohn’s disease and its implication on anal squamous cell cancer management.
576 Background: Anal squamous cell carcinoma (ASCC) is rare, accounting for 1% of gastrointestinal malignancies, but the incidence is rising. Risk factors for the development of ASCC in patients with Crohn’s disease (CD) include immunotherapy, increased duration of disease, and chronic fistulizing perianal disease. We sought to understand management strategies for ASCC in the setting of CD. Methods: A retrospective review from 2001-2016 was conducted for ICD-9/10 codes pertaining to Crohn’s disease (CD) (555.9/ K50) and ASCC (154.3/C44.520). Adult patients with a diagnosis of CD at the time of ASCC diagnosis were included. Results: A total of 7 patients (5 female) were included with a median age of 50 years. The majority presented with perianal pain (4) and bleeding (3). The mean duration of CD was 20 years, and all patients had perianal disease for > 10 years. Five patients had perianal fistulizing disease at the time of ASCC presentation. Clinical stage at diagnosis of ASCC was stage 0 (n = 1), I (n = 1), II (n = 1), III (n = 2), IV (n = 1), and unknown (n = 1). All patients were treated with Nigro protocol which included radiation (50-55Gy), 5-fluorouracil, and mitomycin; 1 patient received cisplatin due to concurrent Non-Hodgkin’s Lymphoma. Three patients required fecal diversion during radiation due to significant perianal disease. Two patients experienced complications related to radiation including anal and vaginal stenosis and an anovaginal fistula. One additional patient required an APR with rectus abdominis myocutaneous flap for uncontrolled CD after treatment. During follow-up, 3 of the 7 patients undergoing definitive chemoradiation developed residual or recurrent disease and required salvage APR. All patients were alive at last follow-up, 2 with metastatic disease. 5-year disease free survival was 56%. Conclusions: Patients with ASCC in the setting of CD may be managed with the standard Nigro protocol, but complications from radiation are common in this setting. Three of seven patients required salvage surgery for residual or recurrent disease, and an additional patient required APR for palliation of CD symptoms. Given the aggressive nature of ASCC in this population, surveillance guidelines are necessary.
Locally recurrent colorectal cancer and hepatic metastases: Safety, feasibility, and outcomes after concomitant resection.
535 Background: The most effective management of locally recurrent colorectal cancer (CRC) is resection. This is also true for hepatic metastases (HM). Data remains limited, however, regarding concomitant resection of recurrent CRC and HM. The aims of this study were to determine the feasibility, safety and outcomes in terms of disease-free survival (DFS) and overall survival (OS) in patients undergoing concomitant resection of recurrent CRC with HM. Methods: All patients who underwent resection of recurrent CRC from 1/1995 to 1/2007 at Mayo Clinic, Rochester were reviewed (n=406). The study group consisted of patients who underwentconcomitant resection of locally recurrent CRC and hepatic resection for metastatic CRC (n= 45). Kaplan-Meier Survival was used to estimate DFS and OS. Results: The study group consisted of 27 men and 18 women. The median age was 59 years. Surgical management involved pelvic dissection in 43 patients and ileotransverse colectomy in two. 17 patients required resection of contiguous organs. 24 patients received intra-operative radiation. 34 patients underwent multiple hepatic wedge resections, 6 patients segmentectomy, 3 left hepatectomy, and 2 right hepatectomy. There was no perioperative mortality. Morbidity was 37%, 2 patients required re-operation. The 1, 3, and 5 year DFS was 72.2, 42.3, and 18.5%, respectively. The 1, 3, and 5 year OS was 87.7, 47.6, and 36.2%, respectively. Conclusions: Synchronous resection of locally recurrent CRC and HM is safe and feasible; morbidity is reasonable and mortality zero. DFS and OS in this patient population appear comparable to that of patients undergoing separate, staged resections.
Adjuvant pelvic radiotherapy in patients with stage IVA rectal adenocarcinoma.
711 Background: For patients with stage IVA rectal cancer with liver metastases treated with curative-intent chemotherapy and surgery, the role of adjuvant pelvic radiotherapy (RT) is unclear. The purpose of this study was to evaluate the impact of pelvic RT on oncologic outcomes in this patient population. Methods: We retrospectively reviewed medical records of all patients with stage IVA rectal adenocarcinoma with liver metastases treated with curative-intent resection of the primary tumor and all liver metastases at our institution between 1991 and 2010. Patient and treatment characteristics were compared between patients who did or did not receive pelvic RT using chi-square and unpaired ttests. Survival and recurrence estimates were calculated from date of initial diagnosis using the Kaplan-Meier method. Local recurrence (LR) was defined as recurrence in the pelvis occurring at or before distant recurrence (DR). Cox regression was used to compare rates of freedom from LR (FFLR), freedom from DR (FFDR), and overall survival (OS) between patients who did or did not receive pelvic RT. Results: The analysis included 65 patients. Median patient age at diagnosis was 59 years (range, 27-87). Tumor stage was T2 (n = 4), T3 (n = 53), or T4 (n = 8). The median number of liver metastases was 2 (range, 1-14). Surgery was low anterior resection (n = 54) or abdominoperineal resection (n = 11). All patients received perioperative fluoropyrimidine based chemotherapy. Pelvic RT was administered to 35 patients (54%), either preoperatively (n = 22) or postoperatively (n = 13). Median RT dose was 50.4 Gy (range 25-58). Patient characteristics were similar for those who did or did not receive pelvic RT. Median follow-up was 3.7 years. The 3-year estimates of FFLR, FFDR and OS were 81% vs 58% (p =.056), 35% vs 29% (p =.75), and 66% vs 71% (p =.81) for RT vs no RT, respectively. Conclusions: In this analysis of patients with stage IVA rectal cancer with liver metastases undergoing curative intent therapy, pelvic RT (vs. no pelvic RT) was associated with a trend to lower rates of LR and similar rates of DR and OS.