Economic implications in inflammatory bowel disease: results from a retrospective analysis in an Italian Centre

BACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy.AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs.METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables.RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01).CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones

Anastomosis configuration and technique following ileocaecal resection for Crohn's disease: a multicentre study

A limited ileocaecal resection is the most frequently performed procedure for ileocaecal CD and different anastomotic configurations and techniques have been described. This manuscript audited the different anastomotic techniques used in a national study and evaluated their influence on postoperative outcomes following ileocaecal resection for primary CD. This is a retrospective, multicentre, observational study promoted by the Italian Society of Colorectal Surgery (SICCR), including all adults undergoing elective ileocaecal resection for primary CD from June 2018 May 2019. Postoperative morbidity within 30&nbsp;days of surgery was the primary endpoint. Postoperative length of hospital stay (LOS) and anastomotic leak rate were the secondary outcomes. 427 patients were included. The side to side anastomosis was the chosen configuration in 380 patients (89%). The stapled anastomotic (n = 286; 67%), techniques were preferred to hand-sewn (n = 141; 33%). Postoperative morbidity was 20.3% and anastomotic leak 3.7%. Anastomotic leak was independent of the type of anastomosis performed, while was associated with an ASA grade ≥ 3, presence of perianal disease and ileocolonic localization of disease. Four predictors of LOS were identified after multivariate analysis. The laparoscopic approach was the only associated with a reduced LOS (p = 0.017), while age, ASA grade ≥ 3 or administration of preoperative TPN were associated with increased LOS. The side to side was the most commonly used anastomotic configuration for ileocolic reconstruction following primary CD resection. There was no difference in postoperative morbidity according to anastomotic technique and configuration. Anastomotic leak was associated with ASA grade ≥ 3, a penetrating phenotype of disease and ileo-colonic distribution of CD

National variations in perioperative assessment and surgical management of Crohn's disease: a multicentre study

Aim: Crohn's disease (CD) requires a multidisciplinary approach and surgery should be undertaken by dedicated colorectal surgeons with audited outcomes. We present a national, multicentre study, with the aim to collect benchmark data on key performance indicators in CD surgery, to highlight areas where standards of CD surgery excel and to facilitate targeted quality improvement where indicated. Methods: All patients undergoing ileocaecal or redo ileocolic resection in the participating centres for primary and recurrent CD from June 2018 to May 2019 were included. The main objective was to collect national data on hospital volume and practice variations. Postoperative morbidity was the primary outcome. Laparoscopic surgery and stoma rate were the secondary outcomes. Results: In all, 715 patients were included: 457 primary CD and 258 recurrent CD with a postoperative morbidity of 21.6% and 34.7%, respectively. Laparoscopy was used in 83.8% of primary CD compared to 31% of recurrent CD. Twenty-five hospitals participated and the total number of patients per hospital ranged from 2 to 169. Hospitals performing more than 10 primary CD procedures per year showed a higher adoption of laparoscopy and bowel sparing surgery. Conclusions: There is significant heterogeneity in the number of CD surgeries performed per year nationally in Italy. Our data suggest that high-volume hospitals perform more complex procedures, with a higher adoption of bowel sparing surgery. The rate of laparoscopy in high-volume hospitals is higher for primary CD but not for recurrent CD compared with low-volume hospitals

Switching from VEDOlizumab intravenous to subcutaneous formulation in ulcerative colitis patients in clinical remission: The SVEDO Study, an IG-IBD study

Background: The administration of biological drugs in inflammatory bowel diseases (IBD) is increasingly moving from intravenous to subcutaneous formulations. Aims: To evaluate the efficacy and safety of vedolizumab subcutaneous administration after switching from intravenous administration in ulcerative colitis (UC) patients in corticosteroid-free clinical remission. Methods: An observational, multicentre, prospective study was conducted by the Italian Group for the study of IBD (IG-IBD). UC patients in clinical remission (pMAYO &lt; 2) not receiving steroids for &gt; 8 months before the switch, and with at least 6 months of follow-up were included. Switch from intravenous to subcutaneous vedolizumab was defined as successful in patients not experiencing a disease flare (pMAYO ≥ 2) or needing oral steroids or stopping subcutaneous vedolizumab during the 6 months of follow-up after the switch. Results: Overall, 168 patients were included. The switch was a success in 134 patients (79.8%). Vedolizumab retention rate was 88.7% at month six. C-reactive protein and faecal calprotectin values did not change after the switch (p = 0.07 and p = 0.28, respectively). Ten of the 19 patients who stopped subcutaneous formulation switched back to intravenous formulation recapturing clinical remission in 80%. Side effects were observed in 22 patients (13.1%). Conclusion: Effectiveness of switching from intravenous to subcutaneous vedolizumab formulation in UC patients in steroid-free clinical remission is confirmed in a real-world setting

Long time consequences after STARR procedure: Report of 15 years experience and medico-legal perspective

Introduction:Stapled transanal rectal resection is the most surgical procedure used for obstructed defecation syndrome, rectal prolapse, rectocele and rectal intussusception worldwide. The aim of this study is to report our experience and long time consequences and to offer a new medico -legal perspective. Materials and methods: We retrospective review medical charts of patients treated between 2006 and 2021 by the same team directed by the same senior surgeon. We consider major complications and long time sequelaeses as main object for the discussion. Inclusion and exclusion criteria were created. IRB approved the study. After revision a medico -legal perspective was done based on major complications. Results: During the study period 1726 patients, ages between 18 and 71 years old, were treated with 1280 STARR procedures and 446 "Longo" [was stopped on 2012]; all procedures were performed by the senior surgeon and visited by the team at the same control visit at 7days, 30 days and 12 and 18 months after surgery. All patients had 100 % compliance at 30 days, while 85 % had long time visit (more than 18 months). During the study period 6 % (104 subjects) of patients had minor complications while 1 patient (42 yrs female) reported total fecal incontinence after 18 months (0,05 %). This patient had mental disorder treated with drugs unknown before surgery and long time mental disorder after surgery. We focused on this last case to discuss long time complication Discussion: This survey reports some interesting clinical data; respect to standard complications minor complications such as pain, bleeding and anal discomfort represent less than 10 % of procedures that is a good results in this perineal surgery. For those working with rectal mucosal prolapse, obstructed defecation syndrome, rectocele or rectal intussusception is essential to distinguish these diagnosis to have a good counselling with patient before surgery (at least 1 month before). It is essential to check these patients with a close follow-up especially after surgery, to avoid any other mental discomfort related to fecal incontinence; long time fecal incontinence, without anatomical disorders as our case, could be associated and related to drugs consumption or mental disorder, or perineal insensitivity due to surgical procedure. In conclusion it is essential to have good clinical practice to suggest STARR procedure, having idea about different diseases, different surgical approaches and different long time complications

Residential cognitive-behavioral weight-loss intervention for obesity with and without binge-eating disorder: A prospective case–control study with five-year follow-up

Objective: The aim of this prospective case–control study was to compare the long-term effects of a residential cognitive-behavioral treatment (CBT) for weight loss in severely obese patients with and without binge-eating disorder (BED). Methods: We assessed weight-loss outcomes and psychological impairment in 54 severely obese female patients with BED and 54 patients matched by age, gender, and body mass index (BMI) without BED admitted to a residential CBT program. Body weight was measured at baseline and at 6-month follow-up and was reported by patients in a telephone interview at 5-year follow-up. Depression, eating disorder psychopathology, general psychopathology, and quality of life were assessed using validated instruments at baseline and at 6-month follow-up. Results: Obese patients with and without BED had similar weight loss at 6-month and 5-year follow-ups. Although both groups showed improved psychosocial variables, at 6 months the BED group maintained higher psychological impairment. Nevertheless, at 5-year follow-up more than half of the BED participants were no longer classifiable as having BED. Discussion: The presence of BED does not affect weight-loss outcome in obese patients treated with the residential CBT for weight loss program considered. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2016; 49:723–730)

The eating disorder examination questionnaire: reliability and validity of the Italian version

PURPOSE: To examine the validity and reliability of a new Italian language version of the latest edition of the Eating Disorder Examination Questionnaire (EDE-Q 6.0). METHODS: The sixth edition of the EDE-Q was translated into Italian and administered to 264 Italian-speaking inpatient and outpatient (257 females in their mid-20s) with eating disorder (75.4% anorexia nervosa) and 216 controls (205 females). RESULTS: Internal consistency was high for both the global EDE-Q and all subscale scores. Test-retest reliability was good to excellent (0.66-0.83) for global and subscale scores, and for items assessing key behavioral features of eating disorders (0.55-0.91). Patients with an eating disorder displayed significantly higher EDE-Q scores than controls, demonstrating the good criterion validity of the tool. Confirmatory factor analysis revealed a good fit for a modified seven-item three-factor structure. CONCLUSIONS: The study showed the good psychometric properties of the new Italian version of the EDE-Q 6.0, and validated its use in Italian eating disorder patients, particularly in young females with anorexia nervosa

The IBIS-Q (IBd Identification of Spondyloarthrytis Questionnaire): a novel tool to detect both Axial and Peripheral Arthritis in Inflammatory Bowel Disease patients

Both peripheral and axial spondyloarthritis (SpA) occurs in inflammatory bowel disease (IBD) and represents the commonest extra-intestinal manifestation. We aimed to develop an easy and quick questionnaire through psycometric analysis to identify peripheral and axial SpA in IBD patients within an integrated combined multidisciplinary rheumatological-gastroenterology clinic

The Impact of the SARS-CoV-2 Outbreak on the Psychological Flexibility and Behaviour of Cancelling Medical Appointments of Italian Patients with Pre-Existing Medical Condition: The \u201cImpACT-COVID-19 for Patients\u201d Multi-Centre Observational Study

Psychological distress imposed by the SARS-CoV-2 outbreak particularly affects patients with pre-existing medical conditions, and the progression of their diseases. Patients who fail to keep scheduled medical appointments experience a negative impact on care. The aim of this study is to investigate the psychosocial factors contributing to the cancellation of medical appointments during the pandemic by patients with pre-existing health conditions. Data were collected in eleven Italian hospitals during the last week of lockdown, and one month later. In order to assess the emotional impact of the SARS-CoV-2 outbreak and the subject's degree of psychological flexibility, we developed an ad hoc questionnaire (ImpACT), referring to the Acceptance and Commitment Therapy (ACT) model. The Impact of Event Scale-Revised (IES-R), the Depression, Anxiety and Stress Scale (DASS) and the Cognitive Fusion Questionnaire (CFQ) were also used. Pervasive dysfunctional use of experiential avoidance behaviours (used with the function to avoid thought, emotions, sensations), feelings of loneliness and high post-traumatic stress scores were found to correlate with the fear of COVID-19, increasing the likelihood of cancelling medical appointments. Responding promptly to the information and psychological needs of patients who cancel medical appointments can have positive effects in terms of psychological and physical health

Single-incision laparoscopic surgery (SILS) for the treatment of ileocolonic Crohn's disease: a propensity score-matched analysis

Introduction Single-incision laparoscopic surgery (SILS) aims to minimize the surgical access trauma by reducing the number of abdominal incisions to a single site, potentially offering better cosmetic results and decreased postoperative pain. In this study, we compare the results of SILS ileocolic resection for Crohn's disease (CD) to conventional laparoscopy and open surgery using a propensity score-matched analysis in a retrospective national multicentre study. Methods All consecutive patients undergoing elective SILS ileocaecal or redo ileocolic resection for primary and recurrent CD from 1 June 2018 to 31 May 2019 were included. Patients were matched 1:1:1 with laparoscopy and open surgery according to perianal disease, recurrent disease, penetrating phenotype of CD, history of previous abdominal surgery, preoperative medical treatment with steroids and anti-TNF. Postoperative morbidity within 30 days of surgery was the primary endpoint. Results Fifty-eight patients were included in each group, for a total of 174 patients. The conversion rate for SILS and laparoscopy was 10.3% and 12%, respectively, with no difference in the incidence of postoperative complications (13.8% and 12%, p = 0.77), whilst open surgery demonstrated a worse morbidity profile, with a complication rate of 25.9% (p &lt; 0.0001). Median length of hospital stay following SILS ileocolic resection was 5 days, significantly shorter compared to 7 days for laparoscopy and 9 for open surgery (p &lt; 0.0001). Conclusions SILS ileocolonic resection for CD demonstrated a comparable morbidity profile compared to laparoscopy in selected patients, with a reduced length of postoperative hospital stay