bluuebunny/crossref_metadata_2025 huggingface dataset:
The spanning plate as an internal fixator in complex distal radius fractures – a prospective cohort study
Authors: Liechti R , Babst R , Hug U , Link B -C , van de Wall B , Knobe M , Beeres F
Published: May 2021

Objective

Minimal invasive temporary spanning plate (SP) fixation of the wrist has been described as an alternative treatment method in complex distal radius fractures (DRFs). The purpose of this study is to conduct an outcome analysis of all consecutive DRFs treated by SP fixation representing the so far largest published patient cohort outside the United States.

Methods

Indication for SP fixation included DRFs with severe metaphyseal comminution, radiocarpal luxation fractures with concomitant ligamentous injuries and very distal intra-articular fractures lacking the possibility of adequate plate anchoring. All consecutive patients undergoing SP fixation of DRFs were prospectively included in a single level I trauma centre between 01/01/2018 and 31/12/2020. Post-operative assessments included radiological, functional and patient-rated outcomes at a minimum of 12 months follow-up.

Results

In the mentioned timeframe, a total of 508 DRFs were treated operatively of which 28 underwent SP fixation. Average age was 58.1 years (range 22-95 years). The fracture type ranged from AO/OTA type B1.1 to C3.3 and included 8 fracture dislocations. SP removal was performed on average 3.7 months after the initial operation (range 1.4-6.5 months). The mean follow-up time was 14.5 months (range 12-24 months). Radiological evidence of fracture healing appeared on average 9.9 weeks (range 5-28 weeks) after the initial operation. One patient experienced oligosymptomatic non-union. Complications included 2 patients with tendon rupture and one patient with extensor tendon adhesions needing tenolysis at the time of plate removal leaving an overall complication rate of 12%. There was no implant failure and no infection. Mean satisfaction score was 8 (range 0-10) and mean visual analogue scale for resting pain was 0.9 (range 0-9). The mean PRWE score was 17.9 (range 0-59.5) and the mean DASH score was 16.6 (range 0-60.8). Grip strength averaged 23kg (range 4-74kg) amounting to 68% of the opposite side. Mean radial inclination, volar tilt and ulnar variance at 1 year were all within the acceptable limit predictive of symptomatic malunion.

Conclusion

The radiological, functional and patient-rated outcomes in this study are remarkably good considering the complexity of the included fractures. Therefore, this method represents a valuable alternative for the treatment of complex DRFs in selected patients.
Renal autotransplantation – reappraisal of an old technique
Authors: Akifi S , Gürke L , Wolff T
Published: May 2021

Objective

Transplantation of the patient’s own kidney into the iliac fossa has been described already more than 50 years ago, predominately for the treatment of renal trauma or peripheral renal artery aneurysms. The technique is however rarely used. We describe our experience with renal autotransplantation.

Methods

Retrospective analysis of consecutive patients.

Results

We performed renal autotransplantation in 3 patients from 2017-2019. The first patient was a 72y old male who had previously multiple stents placed in both renal arteries for renal artery stenosis and presented with a high grade in-stent stenosis of the right renal artery, complete occlusion of the left renal artery and left renal atrophy. The second patient was a 56y old male who presented with a 29mm aneurysm in the bifurcation of the left renal artery. The third patient was a 29y female with Takayasu disease, who had undergone endarterectomy of the abdominal aorta and vein bypass to the left renal artery as a child and stenting of the abdominal aorta for restenosis. She presented with aneurysmatic dilatation and high-grade restenosis of the vein bypass to the left renal artery. In the first two patients, laparoscopic nephrectomy via a retroperitoneal approach was performed as for living donor nephrectomy. The patient with the renal artery aneurysm had back table resection of the aneurysm and reconstruction by forming a common ostium of the two branch arteries. In the third patient, we explanted the kidney via laparotomy. In all patients, the kidney was perfused with cooled organ preservation solution after a brief period of warm ischemia and transplanted in the iliac fossa in standard fashion. After a median follow-up of 20 months (range 9-31) all autotransplanted kidneys showed good perfusion with no signs of renal artery stenosis. Median creatinine clearance was 97ml/min/1.7m2 (range 59-118).

Conclusion

Renal autotransplantation is a safe and durable procedure worth remembering when evaluating the treatment options of complex renal artery pathologies. Its use can also be envisaged for the treatment of complex renal trauma or complex ureter lesions.
In-hospital and mid-term outcome after complex endovascular aortic repair with fenestrated and branched stent-grafts
Authors: Makaloski V , Broger D , Weiss S , Jungi S , Becker D , Schmidli J
Published: May 2021

Objective

The aim of the study is to evaluate in-hospital and mid-term outcome after complex endovascular aortic repair with fenestrated and branched stent-grafts (fEVAR / bEVAR).

Methods

This is a single-center retrospective analysis from a prospectively collected database of all patients treated electively with fEVAR or bEVAR for para/suprarenal (PAA) and thoraco-abdominal aortic aneurysm (TAAA) between September 2010 and June 2019. In-hospital and mid-term mortality, major adverse events and re-interventions were assessed.

Results

Fifty-one patient (84% male) with a mean age of 74±7 years were analysed. Eighteen patients (35%) had TAAA, four patients (8%) suprarenal, and 29 patients (57%) pararenal aortic aneurysms. Mean aneurysm diameter was 64±8 mm. Thirty-eight patients (75%) underwent fEVAR and 13 patients (25%) bEVAR. A total of 157 target vessels were incorporated: 22 celiac trunks (CT), 40 superior mesenteric arteries (SMA), 92 renal arteries (RA), two separate hepatic arteries and one splenic artery. No in-hospital death or stroke was recorded. One patient suffered from early postoperative paraplegia and did not recover and one had paraparesis after 38 days and recovered completely. Six patients (12%) with patent renal arteries experienced acute postoperative kidney injury; one required temporary dialysis. Five in-hospital re-interventions were stent-graft related (four bridging stents angioplasty and one iliac leg extension) and seven re-interventions were not stent-graft related.

Mean follow-up was 19±17 months. Eleven patients (22%) died during follow-up: nine were not aortic-related and two were unknown. The Kaplan-Meier estimated survival rates at 1 and 2 years were 81% and 77%, respectively. Five renal stents (5%, 5/92) occluded during follow-up: three were successfully recanalized and two remained occluded. Ten stents (three CT, five SMA, and two RA stents required relining after 13±16 months postoperatively, resulting with estimated primary assisted patency at 2 years of 100%, 100%, 93%, and 95% for the CT, SMA, right RA and left RA, respectively.

Conclusion

Complex endovascular aortic repair with fEVAR / bEVAR for PAA and TAAA is safe with very low early mortality and morbidity. In-stent stenosis/occlusions occurred within the first two years. However, primary assisted patency was high. A surveillance program to detect potential stent-graft related complications is mandatory.
Early-cannulation arteriovenous grafts are safe and effective in avoiding recurrent tunneled central catheter infection
Authors: Richarz S , Stevenson K , White B , Thomson P , Jackson A , Isaak A , Kingsmore D
Published: May 2021

Objective

Tunneled central venous catheter infection (TCVCi) is a common complication that often necessitates removal of the TCVC and a further TCVC. Theoeretically, insertion of an early-cannualtion graft (ecAVG) early after TCVC infection is possible but not widely practiced with concerns over safety and infection in the ecAVG. With 8 years of ecAVG experience, the aim of this study was to compare the outcomes following TCVC infection, comparing replacement with TCVC (TCVCr) versus immediate ecAVG (ecAVGr).

Methods

Retrospective comparison of two cohorts, who underwent replacement of an infected TCVC either by an early cannulation graft (n = 18) or by a further central catheter (n = 39).

Data were abstracted from a prospectively completed electronic patient record and collected on patient demographics, TCVC insertion, duration and infection, including culture proven bacteriaemia and subsequent access interventions.

Results

18/299 patients identified from 2012-2020 had an ecAVG implanted as treatment for a TCVCi. In a one-year time-period (1/1/2015 -31/12/2015) out of 222 TCVC inserted, 39 were as a replacement following a TCVCi. No patient with an ecAVGr developed an immediate infection, nor complication from the procedure. The rate of subsequent vascular access infection was significantly more frequent for those with TCVCr than with an ecAVGr (0.6 vs. 0.1/patient/ 1000 HD days, p < 0.000). The number of further TCVC required was significantly higher in the TCVCr group (7.1 vs. 0.4/patient/ 1000 HD days, p = 0.000).

Conclusion

An ecAVG early following a TCVC infection is safe, reduces the incidence of subsequent infectious complications and reduces the number of TCVC required, with a better functional patency.
Tele-proctoring in vascular surgery implementing percutaneous creation of arteriovenous fistula
Authors: Isaak A , Mallios A , Gürke L , Wolff T
Published: May 2021

Objective

Percutaneous ultrasound-guided creation of an arteriovenous fistula (pAVF) for hemodialysis access is a relatively novel procedure with promising technical success and patency rates. The vascular surgery departments of two collaborating Swiss hospitals had decided to introduce the technique to their services. A surgeon experienced in the technique (AM) was supposed to come to Switzerland and proctor the first four procedures. Due to the SARS-CoV-2 pandemic and travel restrictions, this was not possible and we decided to perform the first four pAVF procedures tele-proctored via a video conference system. We present the setup and our experience with tele-proctoring.

Methods

The setup relied on an all-in-one live video production device, video encoder, video streamer and video recorder (Pearl-2, Epiphan), which made it possible to simultaneously transmit the live image from the ultrasound device (GE Logiq S8, linear probe 9L-D) and a live image from a video camera (JVC Camcorder G/-HM440E, Japan), both connected via HDMI (Figure). The live stream was shared with the proctor in France and the device support team in the US, using an encrypted Swiss video client (www.vitimway.ch). The setup was tested with all parties three days in advance.

Results

All 4 procedures started with a verbal briefing and a live ultrasound scan. All steps of the procedures were taken under the proctor’s instruction and supervision. The proctor gave on average 21 instructions per procedure. An average 4 were device-related but these became less frequent as we proceeded. The operators consulted the proctor on average 5 times per procedure. The average duration of the procedure was 34 min. The pAVF creation was successful in all 4 patients, with an average fistula flow measured at the end of the procedure of 600 ml/min.

Conclusion

Our experience showed us that pAVF creation, which is a procedure performed entirely under sonographic guidance lends itself particularly well to tele-proctoring. The simultaneous transmission of the live sonographic image and the live image of the operators' hands allowed the proctor to supervise and correct the key steps of the procedures. The simplicity of the set-up and the quality of proctor-operator interaction was such a positive experience that we can well envisage a much wider use of tele-proctoring in the future.
First results of spatial reconstruction and quantification of COVID-19 chest CT infiltrates using lung CT analyzer and 3D slicer
Authors: Bumm R , Lasso A , Kawel-Böhm N , Wäckerlin A , Ludwig P , Furrer M
Published: May 2021

Objective

Lung CT scans are early diagnostic tests in evaluation of COVID-19 patients. Data are usually analyzed visually and the extent of infiltrations can only roughly be estimated. The aim of the present study was to create a software to spatially visualize and quantify infiltrated and collapsed areas in lung CT scans and set these volumes into relation with non-affected lung areas.

Methods

A new software "Lung CT Analyzer" (LCTA, 1) was created from scratch in an international team-effort within the 3D medical imaging software 3D Slicer (2). LCTA consists of two components: "Lung CT Segmenter" implements an intuitive and semiautomatic workflow for the generation of lung masks. LCTA then uses masked thresholds of Hounsfield units to detect non-affected versus affected (emphysematous, infiltrated, and collapsed) areas of the lung. Intrapulmonary vessels are subtracted from the other volumes. Segment volumes are expressed in milliliters and displayed in 3D. COVID-Q was defined as affected divided by non-affected volume and can be calculated separately for both lungs.

3D Slicer and LCTA are open source, freely available and maintained on Github.

Results

CT data of twelve patients with moderate to severe COVID-19 (9 m, 3 f) were selected for the present retrospective study. All scans were performed shortly after admission. Thresholds of Hounsfield units (HU) for areas of interest were defined prior to the study and processing was identical for all patients. The median time effort for 3D reconstruction was 8 minutes per patient. For more detailed results please see the enclosed table. A 3D Slicer demo data set (Control) has been included for comparison.

Conclusion

The COVID-19 pandemic promoted fast-paced innovations such as LCTA in our hospital. LCTA was feasible, reproducible and easy to perform. COVID-Q correlated with COVID-19 lung involvement in all cases. All fatal cases showed COVID-Q values of > 2.0.

LCTA enabled the serial 3D reconstruction of infiltrated and collapsed lung areas in lung CT scans. The procedure may be of great help in the future analysis of pulmonary infiltrates of any cause. In COVID-19 disease, volumetric lung CT reconstruction could result in the definition of new prognostic factors, identify patients “at-risk” in the ICU, and be useful for follow-up.

(1) Lung CT Analyzer: https://github.com/rbumm/SlicerLungCTAnalyzer

(2) 3D Slicer: http://slicer.org
Nationwide study on stress perception among surgical residents
Authors: Guglielmetti L C , Gingert C , Holtz A , Westkämper R , Lange J , Adamina M
Published: May 2021

Objective

Declining number of applicants and high attrition of residents are a dire reality. Surgeons in training are confronted to various stressors which interfere with their performance and may promote burnout. This study measures stress levels of Swiss surgical residents while considering age, gender, specialty, position, native language, and experience.

Methods

Swiss surgery residents taking the Surgical Basic Exam from 2016 to 2020 completed the Perceived Stress Scale 10 (PSS). The PSS measures how unpredictable, uncontrollable, and overloaded respondents evaluate their work life. Scores up to 13 are normal and scores around 20 are highly pathologic. High subscores of helplessness (PH) and lower subscores of self-efficay (PSE) indicate distress.

Results

1694 questionnaires were evaluated (return rate 95.7%). Resident median (m) age was 29 years, 56.5% were male and 43.5% female. 72.7% of the residents were in their first 2 years of training, aiming for orthopedic (24%), general surgery (23.8%), urology (6%), or plastic surgery (5.6%). Residents reported a high PSS (m = 15), a high PH (m = 9), and an ordinary PSE (m = 5). Females reported worse PSS (p < 0.001), PH (p < 0.001), and PSE (p = 0.036) than males. Visceral and orthopedic surgeons had significantly better PSS, PH, and PSE.

In multivariable analysis, male sex (p < 0.001), aiming at orthopedic (p = 0.017) or visceral surgery (p = 0.004), and French as a mother tongue (p = 0.037) predicted lower stress levels, while graduating from a country not adjacent to Switzerland led to higher stress (p = 0.047). Similarly, male sex (p < 0.001), visceral surgery (p = 0.032), French mother tongue (p = 0.018), and more than 5 years in training independently predicted lower PH. Last, PSE was not influenced by gender, while residents in training for orthopedic (p = 0.004), visceral (p = 0.007) and urology (p = 0.014) specialities, as well as Italian native speakers (p = 0.017) reported less PSE.

Conclusion

Perceived stress levels are high in both genders in this large, prospective and representative cohort study of Swiss surgical residents. Females endured significantly worse stress and helplessness levels than males. These figures are worrisome as they may directly contribute to the declining attractivity of surgical residencies. Detailed and gender specific analysis of stressors during residency are urgently needed to improve residency programs.
Surgical skill assessment using machine learning algorithms
Authors: Lavanchy J L , Zindel J , Kirtac K , Twick I , Hosgor E , Candinas D , Beldi G
Published: May 2021

Objective

Surgical skill is correlated with clinical outcomes. Therefore, the assessment of surgical skill is of major importance to improve clinical outcomes and increase patient safety. However, surgical skill assessment often lacks objectivity and reproducibility. Furthermore, it is time-consuming and expensive. Therefore, we developed an automated surgical skill assessment using machine learning algorithms.

Methods

Surgical skills were assessed in videos of laparoscopic cholecystectomy using a three-step machine learning algorithm. First, a three-dimensional convolutional neural network was trained to localize and classify the instruments within the videos. Second, movement patterns of the instruments were recorded over time and extracted. Third, the movement patterns were correlated with human surgical skill ratings using a linear regression model to predict surgical skill ratings automatically. Machine ratings were compared against human ratings of four board certified surgeons using a score ranging from 1 (poor skills) to 5 (excellent skills).

Results

Human raters and machine learning algorithms assessed surgical skills in 242 videos. Inter-rater reliability for human raters was excellent (79%, 95%CI 72-85%). Instrument detection showed an average precision of 78% and average recall of 82%. Machine learning algorithms showed an 87% accuracy in predicting good or poor surgical skills, when compared to human raters.

Conclusion

Machine learning algorithms can be trained to distinguish good and poor surgical skills with high accuracy.

This work was published in Sci Rep 11, 5197 (2021). https://doi.org/10.1038/s41598-021-84295-6
Metabolic activity by FDG-PET/CT after neoadjuvant chemotherapy in borderline resectable and locally advanced pancreatic cancer and association with survival
Authors: Lee Woohyung , Oh Minyoung , Kim Jae Seung , Park Yejong , Kwon Jae Woo , Jun Eunsung , Song Ki Byung , Lee Jae Hoon , Hwang Dae Wook , Yoo Changhoon , Kim Kyu-Pyo , Jeong Jae Ho , Chang Heung-Moon , Ryoo Baek-Yeol , Park Seo Young , Kim Song Cheol
Published: May 2021

Background

The optimal prognostic markers for neoadjuvant chemotherapy in patients with borderline resectable or locally advanced pancreatic cancer are not yet established.

Method

Patients who received neoadjuvant chemotherapy prior to surgery and underwent FDG-PET/CT between July 2012 and December 2017 were included. Metabolic parameters including standardized uptake value (SUV), metabolic tumour volume (MTV), and total lesion glycolysis (TLG) on PET/CT, and response evaluations using PERCIST criteria, were investigated for its impact on survival and recurrence. Cox proportional hazards model was performed. Differences in risk were expressed as hazard ratio (HR) with 95 per cent confidence interval.

Results

The patients with borderline resectable (N = 106) or locally advanced pancreatic cancer (N = 82) were identified. The median survival was 33.6 months. Decreased metabolic parameters of PET/CT after neoadjuvant chemotherapy were associated with positive impacts on survival and recurrence such as SUVmax (HR 1.16, 95 per cent c.i. 1.01 to 1.32, P = 0.025), SUVpeak (HR 1.26, 95 per cent c.i. 1.05 to 1.51, P = 0.011), and MTV (HR 1.15, 95 per cent c.i. 1.04 to 1.26, P = 0.005). Large delta values were related to a positive impact on recurrence such as SUVmax (HR 1.21, 95 per cent c.i. 1.06 to 1.38, P = 0.005). Post-neoadjuvant chemotherapy SUVmax ≥3 (HR 3.46, 95 per cent c.i. 1.21 to 9.91; P = 0.036) was an independent prognostic factor for negative impact on survival. Patients with post-neoadjuvant chemotherapy SUVmax <3 showed more chemotherapy cycles (8.7 versus 6.2, P = 0.001), more frequent complete metabolic response (25 versus 2.2 per cent, P = 0.002), smaller tumour size (2.1 versus 3.1 cm, P = 0.002), and less frequent lymphovascular invasion (23.7 versus 51.1 per cent, P = 0.020) than patients with SUVmax ≥3.

Conclusion

Reduction in metabolic tumour parameters of FDG- PET/CT after neoadjuvant chemotherapy indicates improved overall survival and recurrence-free survival.
Development and Validation of a Sensitive GC–MS/MS Method for the Determination of Five Potential Genotoxic Impurities in Abiraterone Acetate
Authors: Zhong ZhenHua , Chen YuPing , Xia HongYing , Chen ZhenZhen , Cheng QiZhen
Published: May 2021

A sensitive and selective gas chromatography–tandem mass spectrometry method was developed for the identification and quantification of five potential genotoxic impurities (PGIs), i.e., chloromethane, 2-chloropropane, 2-bromopropane, 4-chloro-1-butanol and diethyl sulfate, in abiraterone acetate. The method was validated according to the International Council for Harmonisation (ICH) guidelines. The linearity was established for the concentration range of 30–480 ng/mL (2-chloropropane, 2-bromopropane, 4-chloro-1-butanol and diethyl sulfate) and 90–1440 ng/mL (chloromethane). The correlation coefficient of each PGIs was >0.995. The extraction recoveries ranged from 90.49 to 106.79% for the five PGIs. The quantitation limit, detection limit, accuracy, precision, repeatability and stability of the method demonstrated that the method was an adequate quality control tool for quantitation and identification of chloromethane, 2-chloropropane, 2-bromopropane, 4-chloro-1-butanol and diethyl sulfate at trace levels in drug substances and drug products.
DOP23 Single-cell RNA sequencing identifies an important role for class I histone-deacetylase enzymes in intestinal myofibroblasts from patients with Crohn’s Disease strictures
Authors: Lewis A , Pan-Castillo B , Berti G , Felice C , Gordon H , Gadhok R , Minicozzi A , Chinaleong J , Feakins R , Lindsay J , Silver A
Published: May 2021

Background

Histone-deacetylase (HDAC) enzymes are a broad class of ubiquitously expressed enzymes that modulate histone acetylation, chromatin accessibility and gene expression. In models of Inflammatory bowel disease (IBD), HDAC inhibitors, such as Valproic acid (VPA) are proven anti-inflammatory agents and evidence suggests that they also inhibit fibrosis in non-intestinal organs. However, the role of HDAC enzymes in stricturing Crohn’s disease (CD) has not been characterised; this is key to understanding the molecular mechanism and developing novel therapies.

Methods

To evaluate HDAC expression in the intestine of SCD patients, we performed unbiased single-cell RNA sequencing (sc-RNA-seq) of over 10,000 cells isolated from full-thickness surgical resection specimens of non-SCD (NSCD; n=2) and SCD intestine (n=3). Approximately, 1000 fibroblasts were identified for further analysis, including a distinct cluster of myofibroblasts. Changes in gene expression were compared between myofibroblasts and other resident intestinal fibroblasts using the sc-RNA-seq analysis pipeline in Partek. Changes in HDAC expression and markers of HDAC activity (H3K27ac) were confirmed by immunohistochemistry in FFPE tissue from patient matched NSCD and SCD intestine (n=14 pairs). The function of HDACs in intestinal fibroblasts in the CCD-18co cell line and primary CD myofibroblast cultures (n=16 cultures) was assessed using VPA, a class I HDAC inhibitor. Cells were analysed using a variety of molecular techniques including ATAC-seq, gene expression arrays, qPCR, western blot and immunofluorescent protein analysis.

Results

Class I HDAC (HDAC1, p= 2.11E-11; HDAC2, p= 4.28E-11; HDAC3, p= 1.60E-07; and HDAC8, p= 2.67E-03) expression was increased in myofibroblasts compared to other intestinal fibroblasts subtypes. IHC also showed an increase in the percentage of stromal HDAC2 positive cells, coupled with a decrease in the percentage of H3K27ac positive cells, in the mucosa overlying SCD intestine relative to matched NSCD areas. In the CCD-18co cell line and primary myofibroblast cultures, VPA reduced chromatin accessibility at Collagen-I gene promoters and suppressed their transcription. VPA also inhibited TGFB-induced up-regulation of Collagen-I, in part by inhibiting TGFB1|1/SMAD4 signalling. TGFB1|1 was identified as a mesenchymal specific target of VPA and siRNA knockdown of TGFB1|1 was sufficient suppress TGFB-induced up-regulation of Collagen-I.

Conclusion

In SCD patients, class I HDAC expression is increased in myofibroblasts. Class I HDACs inhibitors impair TGFB-signalling and inhibit Collagen-I expression. Selective targeting of TGFB1|1 offers the opportunity to increase treatment specificity by selectively targeting meschenymal cells.
DOP29 The Normalization and Transition of J-Pouch Phenotype in the Chicago Classification of Pouchitis
Authors: Akiyama S , Cohen N , Traboulsi C , Rai V , Glick L , Yi Y , Runde J , Cohen R , Skowron K , Hurst R , Umanskiy K , Shogan B , Hyman N , Rubin M , Dalal S , Sakuraba A , Pekow J , Chang E , Ollech J , Rubin D
Published: May 2021

Background

Pouchitis can develop in up to 70% of patients with inflammatory bowel disease (IBD) treated by proctocolectomy with ileal pouch-anal anastomosis (IPAA). In our recent work, we proposed the “Chicago classification of pouchitis” describing 7 main pouch phenotypes with differing outcomes. In this study, we assessed the transition of pouch phenotypes in our classification.

Methods

This is a retrospective study of IBD patients with IPAA who subsequently underwent pouchoscopies at the University of Chicago between June 1997 and December 2019. We reviewed all available reports of pouchoscopies after ileostomy takedown and classified the pouches into 7 main phenotypes: (a) normal, (b) afferent limb (AL) involvement, (c) inlet (IL) involvement, (d) diffuse, (e) focal inflammation of the pouch body, (f) cuffitis, and (g) pouch fistulas (Figure 1). A normal pouch was defined as a pouch without any abnormal findings including fistulas. AL, IL involvement, and cuffitis were defined as any type of endoscopic inflammation in the AL, IL, and rectal cuff, respectively. Diffuse inflammation was defined as two or more endoscopic inflammatory findings in all anatomical locations of the pouch body (the tip, proximal, and distal pouch). Focal inflammation was defined as pouchitis that did not meet the criteria for diffuse inflammation. Pouch fistulas included pouches with any type of fistulas noted ≥6 months from ileostomy takedown. Using a Kaplan-Meier curve, event-free survival (EFS) was assessed from the scope date when a primary phenotype was first identified to the date when a subsequent phenotype was described. We excluded patients if a subsequent phenotype was identified before or at the scope date when a primary phenotype was initially noted. Logistic regression analysis was performed with variables with a P-value <0.05 in a Fisher’s exact test.

Results

We reviewed 1,359 pouchoscopies from 426 patients (90% preoperative diagnosis of ulcerative colitis). The most common subsequent inflammatory phenotype was focal inflammation (55%-88%), followed by IL involvement (31%-67%), cuffitis (33%-46%), diffuse inflammation (20%-38%), AL involvement (21%-32%), and pouch with fistulas (9%-20%). The rate of subsequent normal pouch was 6%-25% with pouch fistulas having the lowest normalization rate (6%, 5-year EFS 93%) (Table 1, Figure 2). On multivariable analysis, pouch fistulas were negatively associated with pouch normalization (OR 0.17, 95% CI 0.06–0.48) (Table 2).

Conclusion

We demonstrated that pouch phenotype can change over time and pouch normalization is possible. Further studies are needed to determine if pouch normalization should be a goal of treatment for IBD patients with IPAA.
DOP33 Predictors of ileo-rectal anastomosis, permanent ileostomy and recurrence of disease after total colectomy for Crohn’s Colitis: Results over 20 years
Authors: Rottoli M , Melina M , Tanzanu M , Romano A , Belvedere A , Parlanti D , Pezzuto A P , Salice M , Rizzello F , Gionchetti P , Poggioli G
Published: May 2021

Background

Patients with surgical Crohn’s colitis (CC) might either undergo a total colectomy (TC) and ileo-rectal anastomosis (IRA), or TC and end ileostomy. Among the latter group, a second-stage IRA is not always performed. The predictors of the different outcomes after TC (including the recurrence of disease at the level of the anastomosis) are yet to be identified.

Methods

Retrospective study including 354 patients undergoing TC for CC (2000–2019), with a minimum preoperative follow-up of 2 years in our centre. The mean postoperative follow-up was 67.5+/-49.8 months (62 patients lost). The primary end-points were to identify the predictors for the following outcomes:

a) IRA (87 cases, 24.6%) vs. end ileostomy (267 cases, 75.4%) at the primary colectomy.

b) second-stage IRA (80 cases, 39%) vs. no IRA (125 cases, 61%) at the last follow-up.

c) recurrence of the disease after IRA (167 patients).

Considering the large number of regressors and the risk of over-fitting, the least absolute shrinkage and selection operator (LASSO) method was used. A multivariate analysis was carried out using the preselected covariates. The analysis was conducted using logistic regression and cox regression for dichotomus and time-dependent outcomes. A p-value<0.05 was considered significant.

Results

a) Predictors against the IRA at primary TC: preoperative biologic exposure (OR=1.96, CI 1.15–3.33, p=0.014), Crohn’s rectal location (OR=4.17, CI 2.0–8.33, p<0.0001), perianal disease (OR=3.33, CI 1.75–6.25, p<0.0001), and low hemoglobin concentration (OR=1.26, CI 1.01–1.58, p=0.037).

b) Predictors of the risk of still having the ileostomy at the follow-up: age (OR: 1.02, CI 1.00–1.04, p=0.045), exposure to biologics before (OR 1.85, CI 1.11–3.03, p=0.017) and after (OR 1.79, CI 1.11–2.89, p=0.018) the TC; postoperative use of azathioprine was associated with a greater chance of a second-stage IRA (OR 2.66, CI 1.21–5.83, p=0.014).

c) Risk of anastomotic recurrence was 8.7% and 30.8% at 5 and 10 years. Significant predictors were: female gender (OR 2.38, CI 1.11–5.55, p=0.046), use of more than one biologic (OR 5.65, CI 2.18–9.89, p<0.0001) and worsening of symptoms needing for drug escalation (OR 5.51, CI 2.06–8.59, p=0.001) during the follow-up.

Conclusion

The location and severity of the disease at diagnosis predict the long-term behavior of the disease. The exposure to biologics, especially if multiple drugs are required, does not represent a risk for worse outcomes per se, but rather identifies a population at higher risk of permanent ileostomy due to more severe disease. These predictors might be implemented in the assessment of patients affected by CC, in order to identify the population at risk of permanent ileostomy.
DOP40 Comorbidities and epidemiological risk factor but not immunosuppressive therapies increase the risk of COVID-19 in Inflammatory Bowel Disease (IBD): An ENEIDA-based, case-control study
Authors: Zabana Abdo Y , Marín-Jiménez I , Rodríguez-Lago I , Vera I , Martín M D , Guerra I , Gisbert J P , Mesonero F , Benítez O , Taxonera C , Ponferrada-Díaz Á , Piqueras M , Lucendo A , Caballol B , Mañosa M , Martínez-Montiel P , Bosca-Watts M , Gordillo J , Bujanda L , Manceñido N , Martínez-Pérez T , López A , Rodríguez C , García-López S , Vega P , Rivero M , Melcarne L , Calvo M , Iborra M , Barreiro-de Acosta M , Arias L , Barrio J , Pérez J L , Busquets D , Pérez-Martínez I , Navarro-Llavat M , Hernández V , Argüelles-Arias F , Domènech E , Esteve M
Published: May 2021

Background

The information regarding IBD patients with COVID-19 suggests that the factors related to bad outcome are older age and comorbidity whereas immunosuppressants do not have a significant impact worsening the disease evolution. To date, there is no information to assess if there are differences in epidemiological, demographical, and clinical characteristics between infected and non-infected IBD patients.

Methods

Case-control study in IBD patients with COVID-19 (cases) compared to IBD without COVID-19 (controls) in the period March-July/2020 within the ENEIDA registry (promoted by GETECCU and with more than 60.000 IBD patients included). Cases were matched 1:2 by age (±5y), type of disease (CD/UC), gender, and centre. All controls were selected from only one investigator blind to other clinical characteristics of the patients to avoid selection bias.

Results

496 cases and 964 controls from 63 Spanish centres were included. No differences were found within the basal characteristics including CD location, CD behaviour, extraintestinal manifestations, family history of IBD or smoking habits. Cases had ≥ 1 comorbidities (cases:43%vs. controls:36%, p=0.01) and occupational risk (cases:27% vs. controls:10.6%, p<0.0001) in a higher proportion. Strict lockdown but not sick leave nor telecommuting was the only measure demonstrating protection against COVID-19 (cases:49% vs. controls:70%, p<0.0001). There were no differences in the use of systemic steroids (p=0.19), immunosuppressants (p=0.54) or biologics (p=0.25) between cases and controls. Cases were more often treated with aminosalicylates (45% vs.34%, p=0.022). Having ≥ 1 comorbidities (OR:1.4, 95%CI: 1–1.8), occupational risk (OR:2.05, 95%CI:1.5–2.9) and the use of aminosalicylates (OR:1.4, 95%CI: 1–1.8) were risk factors for COVID-19. On the other hand, the strict lockdown was a protective factor (OR:0.36, CI:0.27–0.48).

Conclusion

Comorbidities and epidemiological risk factors are the most relevant aspects for the risk of COVID-19 in IBD patients. This risk of COVID-19 seems to be increased by aminosalicylates but not by immunosuppressants or biologics. The attitude regarding treating IBD patients with aminosalicylates during the COVID-19 pandemic deserves a deeper analysis.

Funded by the Carlos III Health Institute COV20/00227.
DOP84 Early treatment responses within 14 days of intravenous vedolizumab induction therapy for Crohn’s Disease: Post hoc analysis of patient-reported outcomes from the VISIBLE 2 study
Authors: D’Haens G , Baert F , Danese S , Kobayashi T , Loftus E V , Sandborn W J , Dornic Q , Lindner D , Kisfalvi K , Marins E G , Vermeire S
Published: May 2021

Background

Vedolizumab (VDZ), an anti-a4β7 integrin antibody that selectively blocks lymphocyte trafficking to the gut, is approved for the treatment of adult patients with moderate-to-severe Crohn’s disease (CD). This post hoc analysis of data from the VISIBLE 2 trial evaluated early patient-reported outcomes assessed within the first 14 days of VDZ induction.

Methods

VISIBLE 2 (NCT02611817; EudraCT 2015-000481-58) was a phase 3, multicentre, placebo-controlled study, evaluating the efficacy and safety of subcutaneous VDZ for maintenance treatment in patients with moderately to severely active CD. Efficacy was assessed based on CD Activity Index (CDAI). Patients received induction treatment with intravenous (IV) VDZ 300 mg open-label at Weeks 0 and 2. For this analysis, responses to VDZ were assessed using CDAI sub-scores for patient-reported abdominal pain (AP) and stool frequency (SF) collected daily via electronic diary in the first 14 days of VDZ treatment (Day 1 to 15) in all patients receiving ≥1 VDZ dose at induction. Descriptive statistics were used.

Results

The analysis included 611 patients (mean [SD] age 37.6 [13.4] years; CD duration 9.0 [8.1] years); 323 (53%) were male; 228 (37%) had severe disease (CDAI >330) at baseline; and 350 (57%) were anti-TNF-experienced. In the first 14 days of VDZ IV induction, the rate of patients with daily SF≤3 increased from 30% at baseline (Day 1) to 47.7% on Day 15. Increases were similar in both anti-TNF-naïve vs. anti-TNF-experienced patients and in patients with severe vs. moderate disease (Figure 1). Mean baseline SF was reduced from 6.4 to 5.0 at Day 15 in patients with severe disease and from 4.3 to 3.5 in patients with moderate disease. Overall, the proportion of patients rating AP as severe/moderate declined from baseline to Day 15 of induction (from 14.6% to 8.2% for severe AP and from 60.7% to 40.6% for moderate AP). Similar Day 1-to-15 reductions were reported in both anti-TNF-naïve (severe AP: 14.2% to 9.2%; moderate AP: 62.6% to 44.6%) and anti-TNF-experienced patients (severe AP: 14.8% to 7.4%; moderate AP: 59.3% to 37.7%), respectively. Although a minority of patients (6.3%) in the sub-group with moderate AP at baseline had worse pain at Day 15, there were early improvements in AP ratings for most patients reporting severe or moderate AP at baseline (Figure 2).

Conclusion

This post hoc analysis of daily patient-reported SF and AP in the VISIBLE 2 CD study indicates an early onset of response to VDZ IV induction within the first 14 days of treatment.
P148 ANA and Anti-dsDNA antibody enabling the prediction of inflammatory arthritis in inflammatory bowel disease
Authors: de Sousa Magalhães R , Lima Capela T , Rosa B , Moreira M J , Cotter J
Published: May 2021

Background

Inflammatory arthritis is frequent as an extraintestinal manifestation of IBD, as well as a paradoxical reaction to biological treatment. Anti-nuclear antibody (ANA) and Anti-dsDNA antibody have been associated with inflammatory arthritis. We aim to assess the correlation between the presence of ANA and Anti-dsDNA antibody and the diagnosis of inflammatory arthritis in patients with IBD under biological treatment.

Methods

We present a cohort study, including IBD patients under biological treatment, presenting at least a treatment session in the first 2 months of 2020. Data was gathered from medical records, laboratorial analysis, namely ANA and Anti-dsDNA, were collected in the treatment session, and every patient posteriorly answered telephonically validated questionnaires to assess the presence of inflammatory arthritis, the outcome variable. A univariate analysis followed by a multivariate logistic regression, including statistically significant variables, tested the correlation towards inflammatory arthritis. A ROC curve tested the performance of the final model.

Results

We included 122 patients, 64 (52.5%) were women, and the mean age was 39 years old. Eighty-six (70.5%) patients presented Crohn’s Disease and 36 (29.5%) Ulcerative Colitis. A hundred (82%) patients were under Infliximab, 21 under Vedolizumab (17.2%) and only 1(0.8%) under Adalimumab. Thirty-three patients (27%) met questionnaire criteria for inflammatory arthritis, either peripheric or axial. The variables age, ANA and ANA’s title, age at IBD diagnosis and number of symptomatic articulations involved were associated with the presence of inflammatory arthritis. The multivariate model including ANA (OR 4.149 [1.03–16.711] p=0.045); number of articulations involved (OR 2.683 [1.783–4.038] p<0.001) and higher age at IBD diagnosis, accurately identified patients with diagnosis of inflammatory arthritis (ROC AUC 0.957 [0.926–0.987] p<0.001). A sub-analysis correlating ANA and the presence of inflammatory arthritis after biological initiation showed a statistical tendency (OR 2.231 [0.908–5.478] p<0.08).

Conclusion

The presence of ANA antibodies and a higher number of symptomatic articulations involved independently increased the rate of inflammatory arthritis diagnosis in up to 4 times, in a cohort of patients with IBD under biological treatment. The inclusion in a multivariate model displayed an excellent accuracy and performance towards the diagnosis of inflammatory arthritis. ANA antibodies together with validated questionaries may aid in the identification of IBD patients suffering from inflammatory arthritis.
P152 Bowel ultrasound as an early monitoring tool to assess disease activity in Crohn’s disease patients after induction therapy with infliximab
Authors: Morão B , Nascimento C , Frias Gomes C , Gonçalves T , Castro F , Moreira M J , Cotter J , Pereira F , Caldeira A , Sousa R , Coelho R , Macedo G , Macedo C , Ferreira M , Cravo M , Glória L , Torres J , Palmela C
Published: May 2021

Background

Bowel wall thickness (BWT) is an accurate sonographic parameter to assess disease activity in Crohn’s disease (CD). International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) was developed to allow a reproducible assessment of intestinal inflammation in CD using bowel ultrasound (IUS).

Aim

to assess BWT and IBUS-SAS variation after induction therapy with infliximab (IFX) and their correlation with clinical and laboratory parameters.

Methods

Prospective multicentre study including patients with active CD starting IFX. Harvey-Bradshaw index (HBI), C-reactive protein (CRP), faecal calprotectin (FC) and IUS were performed at week 0 (W0) and 14 (W14). IUS response and remission were defined as a reduction in BWT ≥25% and its normalization(≤3mm) in the most affected segment, respectively. IBUS-SAS was calculated using BWT, Doppler signal, bowel wall stratification (BWS) and inflammatory fat.

Results

We included 37 patients (62% males; median age 30 years, range 16–73). According to Montreal classification, most patients were A2 (70%), had ileocolonic disease (L3 57%) and an inflammatory phenotype (B1 60%); 41% had perianal disease. Most were anti-TNF therapy naive(84%), and combination therapy was used in 62%. Terminal ileum was the most affected segment identified by IUS (60%).

Table 1 shows clinical, laboratory and sonographic parameters [median (IQR)]. At W14, 81% were in clinical remission, 43% in laboratorial remission (normal CRP and FC), 24% had IUS response and 11% had IUS remission. There was a significant reduction in HBI, CRP, FC and sonographic parameters (except for BWS) between W0 and W14. We found a fair to good correlation between BWT and HBI(r=0.363, p=0.03), CRP(r=0.391, p=0.02) and FC(r=0.373, p=0.03) at W14. IBUS-SAS had also a fair to good correlation with CRP(r=0.340, p=0.04) and FC(r=0.527, p=0.001) at W14. The area under the curve of IBUS-SAS for predicting clinical and laboratorial remission was 0.60; best-cut off 64.65 (sens. 57%; specif. 63%).

Conclusion

There was a significant reduction in sonographic parameters after 14 weeks of IFX and one quarter of our patients had an IUS response, suggesting that reduction in BWT could be an early marker of response to therapy. We found a good correlation between IUS and clinical and laboratory parameters at W14. IUS evaluation after induction therapy can be a helpful tool to monitor disease activity and guide CD patient management in our daily practice.
P185 Psychosocial impact of the COVID-19 pandemic on patients with inflammatory bowel disease in Spain
Authors: Hernandez Camba A , Ramos L , Madrid Álvarez M B , Pérez-Méndez L , Nos P , Hernández V , Guerra I , Jimenez N , Lorente R , Sierra-Ausín M , Ginard D , Varela P , Arranz L , Cabello Tapia M J , Zabana Y , Barreiro M
Published: May 2021

Background

Few studies have examined the effects of COVID-19 on the mental health of patients with inflammatory bowel disease (IBD), who are already at higher risk of depression, anxiety and stress than the general population. This cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with IBD in Spain during lockdown and the first wave of the pandemic.

Methods

A self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale–21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of COVID-19 on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey via email or by using a QR code displayed at the unit. A link to the survey was also published on the GETECCU (Spanish IBD group) website and social media account. The survey was conducted between the 1st July and the 25th August 2020.

Results

Of the 693 survey participants with IBD, 67% were female, mean age 43 (12y SD). 61% had ulcerative colitis, 36% Crohn’s disease 3% indeterminate colitis. Only 15 participants were diagnosed with COVID-19: 3 of them required hospital admission and none required ICU admission. Physical activity levels and sleep habits were adversely affected for 79% and 67% of respondents, respectively. In addition, 39% reported a decrease in income due to the pandemic. 95% report having complied with IBD treatment during the COVID-19 pandemic, despite over 50% of them feeling that they were more at risk of infection due to their medication. DASS-21 scores indicate that during the lockdown the estimated prevalence of depression was 10.5% [95% CI 8.2–13%], anxiety 20% [95% CI –17–23%] and stress 18% [95% CI 8.2–13%]. Multivariate analysis is described in table 1.

Conclusion

In the short-term, lockdown during the COVID-19 pandemic seemed to have an impact on the mental health of our IBD patients in Spain. Further follow-up studies should be carried out to determine the real long-term impact, as it’s known that the wellbeing of this population might be affected because of IBD itself.