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Effect of carbon dioxide versus room air insufflation on post-colonoscopic pain: A prospective, randomized, controlled study

Gündüz, Feyza; Kani, Haluk Tarık; Chang, Shannon; Akdeniz, Esra; Eren, Fatih; Yılmaz, Yusuf; Alahdab, Yeşim Özen
BACKGROUND/AIMS/OBJECTIVE:Room air (RA) and carbon dioxide (CO2) are widely used to insufflate the colon to examine the mucosa in colonoscopy. Pain, discomfort, and bloating can be seen during and after colonoscopy secondary to bowel distention. This study aimed to investigate the effect of CO2 on post-procedure pain sensation (PPPS) in comparison with RA. MATERIALS AND METHODS/METHODS:Patients were randomly assigned to the RA and CO2 insufflation groups in a 1:1 ratio. The visual analog scale (VAS) was used to measure the pain before and after the colonoscopy. VAS score of 0 was accepted as the absence of pain and above 0 was accepted as the presence of pain. The primary outcome was to investigate the effect of CO2 insufflation on PPPS. Secondary outcomes were to investigate the other contributing factors affecting PPPS and the effect of CO2 on PPPS in patients with inflammatory bowel disease (IBD). RESULTS:A total of 204 patients were enrolled in the study. No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy. Furthermore, there was no significant difference in pain sensation between the CO2 and RA groups in patients with IBD. When we investigated the other contributing factors to pain sensation, body-mass index (BMI) was found to be significant at 30 minutes and BMI and colonoscopy time were found to be significant at 6 hours afterwards. CONCLUSION/CONCLUSIONS:We found no favorable effect of CO2 insufflation on PPPS in colonoscopy, including in patients with IBD.
PMCID:7659903
PMID: 33169704
ISSN: 2148-5607
CID: 4675902

Real World Effectiveness and Safety of Ustekinumab for Ulcerative Colitis from Two Tertiary IBD Centers in the U.S [Meeting Abstract]

Hong, S; Cleveland, N K; Akiyama, S; Zullow, S; Yi, Y; Shaffer, S; Malter, L; Axelrad, J E; Chang, S; Hudesman, D P; Rubin, D T
INTRODUCTION: Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on the effectiveness and safety in the real world are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from two US tertiary IBD centers.
METHOD(S): Patients with moderately to severely active UC treated with ustekinumab at NYU Langone Medical Center (New York, NY) and University of Chicago Medical Center (Chicago, IL) between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of 2, with a combined rectal bleeding and stool frequency subscore of #1.
RESULT(S): Sixty-six UC patients were included (Table 1). 61% of patients had extensive colitis and overall mean total Mayo score was 6.5 +/- 2.4. 92% of patients had prior exposure to biologics or tofacitinib. 43% and 45% of patients achieved clinical remission by 3 and 12 months, respectively (Figure 1). Anti-TNF non-response and endoscopic Mayo score of 3 were negative predictors of clinical remission at 3 months (Table 2). At 1 year, 50% of patients achieved endoscopic remission and 33% achieved mucosal and histo-endoscopic healing. The achievement of histo-endoscopic healing was significantly associated with lower partial Mayo score (0.5 +/- 0.6 vs. 3.5 +/- 1.7; P < 0.01) and lower stool frequency (0.3 +/- 0.5 vs. 1.4 +/- 0.7; P = 0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis).
CONCLUSION(S): In this cohort of mostly biologic-refractory UC patients, treatment with usteki-numab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials
EMBASE:633657267
ISSN: 1572-0241
CID: 4718882

A History of Smoking Is Not Associated with a Higher Risk of Pouchitis: A Systematic Review and Meta-Analysis [Meeting Abstract]

Ramai, D; Kani, T; Caniglia, E; Hudesman, D P; Axelrad, J E; Nicholson, J; Hong, S; Chang, S
INTRODUCTION: Ileal pouch-anal anastomosis (IPAA) is a common surgical procedure in patients with an initial diagnosis of ulcerative colitis (UC), indeterminate colitis (IC), or familial adenomatous polyposis syndrome (FAP). Tobacco smoking has been associated with protection from onset of UC. Smoking has been reported to be both a protective factor and a risk factor for the development of pouchitis. In this systematic review and meta-analysis, we examine the influence of smoking on the risk of pouchitis.
METHOD(S): We identified 16 studies evaluating smoking as a risk factor for developing pouchitis in patients with a history of IPAA in a systematic search performed from inception through May 2020. A meta-analysis was then performed using a random-effects model to generate risk ratios.
RESULT(S): A total of 2,389 IPAA patients were included in the systematic review and meta-analysis. In the included studies, the percentage of patients with a diagnosis of pouchitis ranged from 22% to 72%. The percentage of patients with a history of smoking ranged from 7% to 63%. In total, 919 patients had pouchitis (330 current or former smokers; 589 non-smokers), and 1,470 patients did not have pouchitis (485 current or former smokers; 985 non-smokers). A history of smoking compared with never smoking was not associated with an increased risk of developing pouchitis (RR = 0.96, 95% CI 0.78-1.17, I2 5 68.6%). There was also no significant risk of pouchitis when comparing current smokers versus non-smokers (RR = 1.09, 95% CI 0.93-1.28, I2 5 0%) and former smokers versus non-smokers (RR = 0.95, 95% CI 0.70-1.28, I2 5 79.8%).
CONCLUSION(S): Smoking, past or present, is not associated with an increased risk for the development of pouchitis. This is important to consider when counseling patients on the risks of smoking and pouchitis
EMBASE:633657525
ISSN: 1572-0241
CID: 4718822

Impact of disease severity and time-to-test for clostridioides difficile infection on length of stay in inflammatory bowel disease patients hospitalized with flare [Meeting Abstract]

Verma, A; Varma, S; Freedberg, D E; Hudesman, D P; Chang, S; Axelrad, J E
INTRODUCTION: Guidelines recommend testing inflammatory bowel disease (IBD) patients hospitalized with flare for Clostridioides difficile infection (CDI), though little is known about whether a delay in testing for CDI is related to adverse outcomes. We examined the relationship between time to C. difficile PCR test order, collection, and result with adverse IBD outcomes.
METHOD(S): We performed a retrospective cohort study of IBD patients hospitalized with flare through the emergency department (ED) between 2013 and January 2020 at an urban academic medical center. The time from ED presentation to CDI test order (time-to-order), sample collection (time-to-collection), and test result (time-to-result) were collected. Time-to-result was stratified by within+/-hours, 6-24 hours, and 24 hours or longer. The primary outcome was length of stay (LOS). Secondary outcomes were inpatient anti-TNF administration and surgery. Separately, we used initial hemodynamic and laboratory values to create an IBD hospitalization severity score for evaluation against LOS and time-dependent variables.
RESULT(S): We identified 122 IBD patients hospitalized with flare. There were no significant differences in baseline characteristics among time-to-result groups. There was no difference in time-toorder between the+/-hours and 6-24 hours groups (Table 1). Despite a shorter time-to-result, the average LOS in the+/-hours group was 7.3 days, longer compared to the 6-24 hours group (4.3 days, P=0.018) and the 24 hours group (4.2 days, P=0.035Table 1). There were no differences in inpatient anti-TNF administration (P=0.10) or surgery (P=0.08) among time-to-result groups. Markers of disease severity correlated with longer LOS and earlier time-to-result (Table 2). A composite of these markers was used to stratify patients by disease severity. Those with more severe disease had earlier times-to-result (12.8 hours vs. 32.2 hours, P=0.014) and had a longer LOS (7.9 vs. 3.4 days, P=0.007) with no difference in time-to-order compared to patients with less severe disease (P=0.09Table 3).
CONCLUSION(S): Earlier time-to-result for CDI is associated with longer LOS in IBD patients hospitalized with flare. This inverse relationship is confounded by disease severity at presentation. Patients with more severe disease have a shorter time-to-result and a longer LOS without any difference in time-to-order. Delay in testing was not associated with higher rates of inpatient anti- TNF administration or surgery
EMBASE:633655603
ISSN: 1572-0241
CID: 4718952

Update on Laboratory Parameters Related to Monitoring in Patients with Ulcerative Colitis Treated with Tofacitinib in the OCTAVE Open-Label, Long-Term Extension Study [Meeting Abstract]

Melmed, G Y; Chang, S; Kulisek, N; Kwok, K; Lawendy, N; Irving, P M
INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. Changes in liver enzymes, lipids, hemoglobin (Hb), absolute neutrophil count (ANC), and absolute lymphocyte count (ALC) have been observed during 8-wk induction and 52-wk maintenance therapy with tofacitinib in patients (pts) with UC [1]. Monitoring of select parameters is recommended in pts treated with tofacitinib per product labeling [2].
METHOD(S): Changes from baseline in liver enzymes, lipids, ANC, ALC, and Hb were investigated in pts with UC treated with tofacitinib in an ongoing Phase 3, open-label, long-term extension (OLE) study (NCT01470612; data as of May 2019, database not locked). Pts who completed or demonstrated treatment failure in OCTAVE Sustain, or were non-responders after completing OCTAVE Induction 1 or 2, were eligible for the OLE study. Pts in remission at the end of OCTAVE Sustain received tofacitinib 5 mg twice daily (BID); all other pts received tofacitinib 10 mg BID in the OLE study. Proportions of pts with laboratory values meeting protocol discontinuation criteria (Table), proportions of pts with investigator-defined treatment-emergent adverse events (TEAEs) of hyper-lipidemia, and proportions of pts with an addition of or change in lipid-lowering agent (LLA), were also evaluated.
RESULT(S): Changes from OLE study baseline in liver enzymes, lipids, ANC, ALC, and Hb at Months 36 and 48, and the proportion of pts meeting protocol discontinuation criteria, are presented (Table). Findings were generally similar to the previously presented Sep 2018 data cut, which focused on Month 36 [3]. Hyperlipidemia TEAEs occurred in 2.3% and 1.3% of pts treated with tofacitinib 5 and 10 mg BID, respectively. Furthermore, 9.7% and 6.8% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had a new LLA added, and 2.9% and 1.8% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had their LLA dose increased.
CONCLUSION(S): No major changes from OLE study baseline were observed with tofacitinib in laboratory parameters recommended for monitoring up to Month 48. Proportions of pts meeting protocol discontinuation criteria for liver enzymes, ANC, ALC, or Hb, with hyperlipidemia TEAEs, or with a change in LLA, were low. Due to OLE study dose assignment, pt baseline remission status differs across treatment arms
EMBASE:633657943
ISSN: 1572-0241
CID: 4720522

Gender and Racial Disparities in Colorectal Cancer Incidence and Survival: A Population-Based Study [Meeting Abstract]

Ramai, D; Kani, T; Madedor, O; Brooks, O W; Ofosu, A; Barakat, M; Dhindsa, B S; Chandan, S; Dhaliwal, A; Etienne, D; Chang, S; Adler, D G; Reddy, M
INTRODUCTION: Colorectal cancer (CRC) is the third common cause of cancer death in the US. The incidence of CRC is higher in minority racial and ethnic groups. Traditionally, CRC has had a higher mortality rate in men when compared to women. However, studies assessing trends among sex and racial groups on the incidence and mortality of CRC is lacking. We aim to investigate disparities in CRC by reviewing a large national cancer registry.
METHOD(S): This is a retrospective cross-sectional study of the Surveillance, Epidemiology and End Results Registry (SEER) of individuals aged 45-79 years from 2000 to 2017. Race was classified as White, Black, American Indian/Alaska Native, and Asian or Pacific Islander. Annual percent change (APC) and incidence risk ratios (IRR) were calculated for sex and race. Kaplan-Meier estimations and log-rank tests were used to evaluate cancer-specific survival outcomes. Statistical significance was set at P < 0.05.
RESULT(S): Among 690,450 patients, there were 512,285 patients age 45-79 years diagnosed with CRC from 2000 to 2017. A higher proportion of patients had distal tumors versus proximal tumors (62% vs 38%, P < 0.001). SEER summary staging showed that most tumors were localized (40%) compared to regional (35%), distant cancer (20%), and unknown (4%). Approximately 23% of tumors on presentation occurred in the rectum (n = 114,873), followed by 21% in the sigmoid (102,850), 14% in the cecum (70,084), 12% in the ascending colon (n = 60,227), and 29.5% other locations. During the study period, the incidence of CRC decreased for both males and females, respectively (APC 22.14 vs 21.81). Amongst all racial groups, African American showed the least decline in incidence of CRC. African American females showed the highest risk for CRC (IRR 1.34; 95% CI 1.32-1.36, P < 0.001) compared to other females or males from different racial groups [Figure 1]. Subgroup analysis using Kaplan Meier estimations showed that African American females had the poorest 5-year survival rate (56%) compared to White females (66%), American Indian/Alaska Native females (58%), and Asian or Pacific Islander females (66%). Among males, American Indian/Alaska Natives had the poorest 5-year survival (54%) compared to African American males (61%), White males (66%), and Asian or Pacific Islander males (66%).
CONCLUSION(S): Overall, the incidence of colorectal cancer is declining. However, the incidence of CRC remains highest in African Americans females who are also burden with poor survival rates
EMBASE:633656062
ISSN: 1572-0241
CID: 4720642

A clinical and radiographic model to predict surgery for acute small bowel obstruction in Crohn's disease

Lowe, Sarina C; Ream, Justin; Hudesman, David; Malter, Lisa; Bosworth, Brian; Xia, Yuhe; Zhong, Hua; Dane, Bari; Megibow, Alec; Chang, Shannon
PURPOSE/OBJECTIVE:For more than half of Crohn's disease patients, strictures will cause bowel obstructions that require surgery within 10 years of their initial diagnosis. This study utilizes computed tomography imaging and clinical data obtained at the initial emergency room visit to create a prediction model for progression to surgery in Crohn's disease patients with acute small bowel obstructions. METHODS:A retrospective chart review was performed for patients who presented to the emergency room with an ICD-10 diagnosis for Crohn's disease and visit diagnosis of small bowel obstruction. Two expert abdominal radiologists evaluated the CT scans for bowel wall thickness, maximal and minimal luminal diameters, length of diseased segment, passage of oral contrast, evidence of penetrating disease, bowel wall hyperenhancement or stratification, presence of a comb sign, fat hypertrophy, and small bowel feces sign. The primary outcome was progression to surgery within 6 months of presentation. The secondary outcome was time to readmission. RESULTS:Forty patients met the inclusion criteria, with 78% receiving medical treatment alone and 22% undergoing surgery within 6 months of presentation to the emergency room. Multivariable analysis produced a model with an AUC of 92% (95% CI 0.82-1.00), 78% sensitivity, and 97% specificity, using gender, body mass index, and the radiographic features of segment length, penetrating disease, and bowel wall hyperenhancement. CONCLUSIONS:The model demonstrates that routine clinical and radiographic data from an emergency room visit can predict progression to surgery, and has the potential to risk stratify patients, guide management in the acute setting, and predict readmission.
PMID: 32296895
ISSN: 2366-0058
CID: 4383612

A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares

Dulai, Parambir S; Raffals, Laura E; Hudesman, David; Chiorean, Michael; Cross, Raymond; Ahmed, Tasneem; Winter, Michael; Chang, Shannon; Fudman, David; Sadler, Charlotte; Chiu, Ernest L; Ross, Frank L; Toups, Gary; Murad, M Hassan; Sethuraman, Kinjal; Holm, James R; Guilliod, Renie; Levine, Benjamin; Buckey, Jay C; Siegel, Corey A
BACKGROUND:Hyperbaric oxygen has been reported to improve disease activity in hospitalised ulcerative colitis (UC) patients. AIM/OBJECTIVE:To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC patients. METHODS:We enrolled UC patients hospitalised for acute flares (Mayo score 6-12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4 atmospheres (90 minutes with two air breaks) in addition to intravenous steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs 3 days of hyperbaric oxygen. RESULTS:We treated 20 patients with hyperbaric oxygen (75% prior biologic failure). Day 3 response was achieved in 55% (n = 11/20), with significant reductions in stool frequency, rectal bleeding and CRP (P < 0.01). A more significant reduction in disease activity was observed with 5 days vs 3 days of hyperbaric oxygen (P = 0.03). Infliximab or colectomy was required in only three patients (15%) despite a predicted probability of 80% for second-line therapy. Day 3 hyperbaric oxygen responders were less likely to require re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%, P = 0.002). No treatment-related adverse events were observed. CONCLUSION/CONCLUSIONS:Hyperbaric oxygen appears to be effective for optimising response to intravenous steroids in UC patients hospitalised for acute flares, with low rates of re-hospitalisation or colectomy at 3 months. An optimal clinical response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are needed to confirm efficacy and obtain labelled approval.
PMID: 32745306
ISSN: 1365-2036
CID: 4559982

Transabdominal Pouch Salvage for Failed Minimally Invasive Versus Open IPAA: A Case-Matched Study

Aydinli, H Hande; Esen, Eren; Aytac, Erman; Kirat, Hasan T; Schwartzberg, David M; Chang, Shannon; Remzi, Feza H
BACKGROUND:Modality of index IPAA creation may affect the results after redo IPAA surgery for IPAA failure. To our knowledge, there is no study evaluating the effects of modality of index IPAA creation on redo IPAA outcomes. OBJECTIVE:This study aimed to compare short- and long-term outcomes of transabdominal redo IPAA surgery for failed minimally invasive IPAA and open IPAA. DESIGN/METHODS:This was a retrospective cohort study. SETTINGS/METHODS:This investigation was based on a single-surgeon experience on redo IPAA. PATIENTS/METHODS:Patients undergoing transabdominal redo IPAA for a failed minimally invasive IPAA and open IPAA between September 2007 and September 2017 were included. MAIN OUTCOME MEASURES/METHODS:Short-term complications and long-term outcomes were compared between 2 groups. RESULTS:A total of 42 patients with failed index minimally invasive IPAA were case matched with 42 failed index open IPAA counterparts. The interval between index IPAA and redo IPAA operations was shorter in patients who had minimally invasive IPAA (median, 28.5 vs 56.0 mo; p = 0.03). A long rectal stump (>2 cm) was more common after minimally invasive IPAA (26% vs 10%; p = 0.046). Redo IPAAs were constructed more commonly with staplers in the laparoscopy group compared with open counterparts (26% vs 10%; p = 0.046), and other intraoperative details were comparable. Although short-term morbidity was similar between 2 groups, abscess formation (7% vs 24%; p = 0.035) was more frequent in patients who had index IPAA with open technique. Functional outcomes were comparable. Redo IPAA survival for failed minimally invasive IPAA and open IPAA was comparable. LIMITATIONS/CONCLUSIONS:This study was limited by its retrospective, nonrandomized nature and relatively low patient number. CONCLUSIONS:A long rectal cuff after minimally invasive IPAA is a potential and preventable risk factor for failure. Due to its technical and patient-related complexity, handsewn anastomoses in redo IPAA are associated with increased risk of abscess formation. See Video Abstract at http://links.lww.com/DCR/B252. RESCATE DEL RESERVORIO ILEO-ANAL POR VIA TRANSABDOMINAL EN CASOS DE FUGA ANASTOMÓTICA ENTRE ABORDAGE MINIMAMENTE INVASIVO Y ABORDAJE ABIERTO: ESTUDIO DE EMPAREJAMIENTO DE MUESTRAS Y CASOS: La creación de modalidades e índices de Reservorios Ileo-Anales (RIA) pueden afectar los resultados después de rehacer la cirugía de RIAs por fallas en el reservorio. Hasta donde sabemos, no hay ningún estudio que evalúe los efectos de la modalidad de creación de índices RIA en los resultados para el rescate del reservorio.Este estudio tuvo como objetivo comparar los resultados a corto y largo plazo de la cirugía transabdominal redo RIA en casos de fracaso por via mínimamente invasiva (MI-RIA) o por la vía abierta (A-RIA).Estudio de cohortes tipo retrospectivo.Investigación basada en la experiencia de un solo cirujano en redo del Reservorio Ileo-Anal.Se incluyeron aquellos pacientes sometidos a re-operación transabdominal y re-confección de un RIA por fallas en el MI-RIA y en el A-RIA durante un lapso de tiempo entre septiembre 2007 y septiembre 2017.Las complicaciones a corto plazo y los resultados a largo plazo se compararon entre los dos grupos.Un total de 42 pacientes con índice fallido de MI-RIA fueron emparejados con 42 homólogos con índice fallido de A-RIA. El intervalo entre las operaciones de RIA y redo RIA fué más corto en pacientes que tenían MI-RIA (mediana, 28,5 meses frente a 56 meses, p = 0,03). Un muñón rectal largo (> 2 cm) fue más común después de MI-RIA (26% vs 10%, p = 0.046). Redo RIAs se construyeron más comúnmente con engrampadoras en el grupo Minimalmente Invasivo en comparación con la contraparte abiertas (26% vs 10%, p = 0.046). Aunque la morbilidad a corto plazo fue similar entre los dos grupos, la aparición de abscesos (7% frente a 24%, p = 0.035) fue más frecuente en pacientes que tenían RIA con técnica abierta. Los resultados funcionales fueron comparables. La sobrevida de las redo RIAs para MI-RIA y A-RIA fallidas, también fué comparable.Este estudio estuvo limitado por su naturaleza retrospectiva, no aleatoria y el número relativamente bajo de pacientes.Un muñon rectal largo después de MI-RIA es un factor de riesgo potencial y previsible para el fracaso. Debido a su complejidad técnica y relacionada con el paciente, las anastomosis suturadas a mano en redo RIA están asociadas con un mayor riesgo de formación de abscesos. Consulte Video Resumen en http://links.lww.com/DCR/B252.
PMID: 32692073
ISSN: 1530-0358
CID: 4532122

Novel Dual-Energy Computed Tomography Enterography Iodine Density Maps Provide Unique Depiction of Crohn Disease Activity

Dane, Bari; OʼDonnell, Thomas; Ream, Justin; Chang, Shannon; Megibow, Alec
OBJECTIVE:To create a map of iodine densities within affected segments of small-bowel Crohn disease (CD) derived from contrast-enhanced dual-energy computed tomography enterography (DECTE) studies. METHODS:Twenty CD patients imaged with intravenous contrast-enhanced DECTE between June 2016 and December 2017 were retrospectively identified. Ten patients without clinical evidence of CD and 8 normal-appearing jejunal segments in CD patients were controls. Using prototype software, 8 manual contours were drawn along the mucosa of affected segments. Relatively normal-appearing bowel was included at the edges. These contours served as a basis for iodine density calculation and 3-dimensional iodine density map rendering. Color-coded iodine densities allowed detection and quantification of the most and least dense portion of each segment and also permitted relative comparison between segments. RESULTS:The average iodine density per CD involved segment ranged 1.0 to 3.3 mg/mL, which differed significantly from normal ileum (P < 0.0001) and normal-appearing jejunum in patients with CD (P = 0.0009). Standard deviations ranged from 0.8 to 1.7 mg/mL, which differed significantly from normal ileum (P = 0.0039) and normal-appearing jejunum in patients with CD (P = 0.0056). The amplitude of the power spectrum ranged from 0.66 to 3.3 demonstrating patches of iodine rather than uniform distribution. This differed significantly from normal ileum (P = 0.0005) and normal-appearing jejunum in patients with CD (P = 0.0004). CONCLUSIONS:Heterogeneous CD activity and distribution can be displayed as iodine density maps created from DECTE.
PMID: 32936579
ISSN: 1532-3145
CID: 4593102