Adalimumab Therapy in Pediatric Crohn Disease: A 2-Year Follow-Up Comparing "Top-Down" and "Step-Up" Strategies.

OBJECTIVES: European Crohn's Colitis Organization (ECCO) and the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines recommend the early use of anti-tumor necrosis factor (TNF) biologicals in pediatric Crohn disease (CD) patients with positive predictors for poor outcome. The objective of the present study was to compare early "Top-Down" use of adalimumab (ADA) immunomodulator/biologics-naive patients to conventional "Step-Up" management. METHODS: One hundred and twenty consecutive patients with a confirmed diagnosis of CD and treated with ADA between 2008 and 2019 were included and allocated to the ADA-Top Down (n = 59) or ADA-Step Up group (n = 61). The primary endpoint was prolonged steroid-/enteral nutrition-free clinical remission at 24 months, defined by a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) < 12.5. Clinical and biological data were collected at 12 and 24 months. RESULTS: At start of ADA, disease activity was comparable between the ADA-Top Down group and the ADA-Step Up group (wPCDAI = 31 ± 16 vs 31.3 ± 15.2, respectively, P = 0.84). At 24 months, the remission rate was significantly higher in the ADA-Top Down group (73% vs 51%, P < 0.01). After propensity score, the Top-Down strategy is still more effective than the Step-Up strategy in maintaining remission at 24 months [hazard ratio (HR) = 0.36, 95% CI (0.15-0.87), P = 0.02]. Patients in the ADA-Top Down group were mainly on monotherapy compared to patients in the ADA-Step Up group (53/55 vs 28/55 respectively, P < 0.001). Serum levels of ADA were higher in the ADA-Top Down group than in the ADA-Step Up group (12.8 ± 4.3 vs 10.4 ± 3.9 µg/mL, respectively, P < 0.01). There were no serious adverse events. CONCLUSIONS: Early use of ADA appears to be more effective in maintaining relapse-free remission at 2 years, while using it as monotherapy. These findings further favor the recommendation of early anti-TNF use in high-risk CD patients.

Increased Use of Anti-Tumor Necrosis Factor Following the Implementation of the ECCO-ESPGHAN Guidelines and its Impact on the Outcome of Pediatric Crohn's Disease: A Retrospective Single-Center Study.

OBJECTIVES: The first ECCO-ESPGHAN guidelines for the medical management of pediatric Crohn disease (CD) were published in 2014. Whether their implementation, and the consequent increased use of an upfront anti-tumor necrosis factor therapy, have changed the course of the disease has not been investigated yet. We aimed at comparing the evolution of pediatric CD patients diagnosed and treated before and after 2014. METHODS: Single-center retrospective study including all children diagnosed with CD from January 2010 to December 2018. Patients diagnosed between 2010 and 2014 (group 1) were compared to those diagnosed after 2014 (group 2). For each patient, at baseline and every 6-month, number of relapses, the occurrence of complication, therapy received and biological parameters were noted, as well as any endoscopic or radiologic evaluation. RESULTS: One hundred and fifty-four patients were included in the analysis, 78 (51%) diagnosed after 2014. The cumulative probability of a relapse-free and surgery-free course was significantly higher for patients treated according to the guidelines (log rank hazard ratio [HR] = 1,818, P = 0.003 and HR = 3,15, 95% confidence interval, P = 0.04, respectively). Mucosal healing rate was significantly higher among patients of group 2 at 1 and 2 years (P = 0.04 and P = 0.05, respectively), while no significant difference was observed for transmural healing rates, as well as for the risk of complications. CONCLUSIONS: The implementation of the 2014 CD guidelines appears to have a significant impact on disease outcomes, with a significantly lower risk for relapse and surgery, while no effect could be observed on the risk of developing complications.

Pediatric Home Parenteral Nutrition in France: A six years national survey.

BACKGROUND AND AIMS: Home Parenteral Nutrition (HPN) is the cornerstone management for children suffering from chronic intestinal failure (CIF). In France, HPN is organized from a network of 7 certified centers located in University Hospitals spread across the national territory. This study aims to review the data involving children on HPN over a 6-years period in France to outline the global and continuous improvement in care. PATIENTS AND METHODS: This cross-sectional study included all children enrolled in any of the 7 French HPN certified centers from January 1st, 2014 to December 31st, 2019. Data was recorded from annual databases provided by each center regarding: age at inclusion, indication and duration of HPN, type of intravenous lipid emulsion (ILE), outcome [PN weaning off, transfer to adult center, death, intestinal transplantation (ITx)], rate of catheter-related bloodstream infections (CRSBIs) for 1000 days of HPN, Taurolidine lock procedure (TLP) use and prevalence of cholestasis defined as conjugated bilirubin ≥20 µmol/l. RESULTS: The number of patients increased by 43.6% from 268 in 2014 to 385 in 2019. According to the year of follow up, the indications for HPN were short bowel syndrome (SBS) (42.3-46.6%), congenital enteropathies (CE) (18.5-22.8%), chronic intestinal pseudo-obstruction syndrome (CIPOS) (13.0-16.3%), long segment Hirschsprung's disease (LSHD) (9.7-13.3%), Crohn's disease (CD) (1.6-2.6%) and other non-primary digestive diseases (NPDD) such as immune deficiency, cancer or metabolic disease (4.0-9.2%). The median age at discharge on HPN decreased from 11.7 months in 2014 to 8.3 months in 2019 (p < .001). By December 31st, 2019, 44.8% of children had left the HPN program after a median duration ranging between 39.9 and 66.4 months. Among these patients, 192 (74.2%) were weaned off PN (94.7% SBS), 41 (15.8%) were transferred to adult centers for CIPOS (42%), SBS (31%) or CE (27%), 21 died (8.1%) - mostly in relation to cancer or immune deficiency - and 5 were transplanted (1.9%): 4 underwent combined liver-intestine transplantation for LSHD (n = 2), SBS, CE and one multivisceral Tx for CIPOS. The use of a composite fish-oil based ILE increased from 67.4% in 2014 to 88.3% in 2019 (p < 0.001). CRBSIs dropped from 1.04 CRSBIs per 1000 days HPN in 2014 to 0.61 in 2019 (p < 0.001) while meantime, the percentage of children receiving TLP increased from 29.4% to 63.0% (p < 0.001). The prevalence of cholestasis (conjugated bilirubin ≥ 20 µmol/l) was low and stable between 4.1 and 5.9% of children during the study period. CONCLUSION: In France, the number of children enrolled in a HPN program continuously increased over a 6 years period. SBS is the leading cause of CIF requiring HPN. The rate of CRBSIs dropped dramatically as the use of TLP increased. Mortality rate was low and mainly in relation to the underlying disease (cancer, immune deficiency). Cholestasis and intestinal Tx remained very rare.

The use of biofeedback for children with fecal incontinence secondary to retentive constipation: Experience of a French Pediatric Center.

BACKGROUND: Fecal incontinence (FI) secondary to chronic retentive constipation is a frequent demand in pediatric gastroenterology clinics. The management of constipation in children includes laxatives (polyethylene glycol, PEG), enhanced toilet training, and dietary advice. Biofeedback is a possible treatment for children above the age of 7 years with resistant FI. AIM: To analyze any changes in volume to trigger defecation (VTD) and envy score over the course of biofeedback sessions according to clinical response. METHODS: In this retrospective study, we reviewed the medical records of 23 children diagnosed with FI according to the Rome IV criteria and treated with biofeedback. For each biofeedback session, a mean VTD by subject was measured. At the end, therapy was considered a success if soiling disappeared and a failure if any persisted. The need to defecate expressed by the child was described as an envy score. A 0-10 visual analog scale was used to express the intensity of this sensation. Follow-up involved calling the parents 12 months after the biofeedback sessions had ended to assess symptoms remotely. RESULTS: The study included 19 boys and 4 girls with a median age of 10 years. Patients' ages ranged between 7 and 17 years. None of them had any associated neurological disorders. All children had FI for >1 year. The median number of soiling episodes per week was 7. The average number of biofeedback sessions was 3 (range 1-5). At the end of the rehabilitation sessions, 12 children (52%) were in the "success" group. In the latter, median VTD decreased from 97 ml to 70 ml between the first and last session. In the "failure" group, VTD decreased from 120 ml to 100 ml. The between-group difference in the median VTD at the first session was not statistically significant. The last observation carried forward (LOCF) VTD was significantly lower in the "success" group compared to the "failure" group (70 ml versus 100 ml, p = 0.03). Median envy scores decreased during the biofeedback sessions with no statistical difference between the groups at the last session. Follow-up of children in the "success" group one year after the last biofeedback session revealed that 10 patients had no relapse (83%) and 2 were lost to follow-up. CONCLUSIONS: Biofeedback might be an effective tool for the management of FI resistant to medical treatment in children.

Nondepolarizing muscle relaxant improves direct laryngoscopy view with no effect on face mask ventilation / Relaxantes musculares não despolarizantes melhoram a visibilidade em laringoscopia direta sem efeito sobre a ventilação via máscara facial

Abstract Background: Difficult or impossible face mask ventilation complicated with difficult tracheal intubation during anesthesia induction occurs in 0.4% of adult anesthesia cases, possibly leading to life-threatening complications. Because of such catastrophes, muscle relaxants have been recommended to be administered after confirming adequate face mask ventilation without a solid scientific validation of this principal. Methods: In this observational study, the ease of ventilation and the scores of direct laryngoscopy views before and after administration of cisatracurium were assessed in ninety young healthy adults, without anesthetic risks and without foreseen difficult intubation and who were scheduled for general elective surgeries. Results: Before muscle relaxation, 43 patients (48%) were Cormack Grade I, while the remaining 47 patients (52%) were either Cormack Grade II (28 patients, 31%) or Cormack Grade II (19 patients, 21%). Following muscle relaxation with cisatracurium, the number of patients with Cormack Grade I significantly increased from 43 patients (48%) to 65 patients (72%) (p = 0.0013). Only 1 patient out of 19 patients (5%) improved his Cormack grade from Grade III to Grade I while 16 out 19 patients (84%) improved their Cormack grade from Grade III to Grade II after the use of cisatracurium. The quality of face mask ventilation did not differ with and without muscle relaxants in all patients. Conclusion: The use of cisatracurium in healthy young adults undergoing general elective surgeries with no anticipated difficult endotracheal intubation had no effect on the quality of face mask ventilation despite resulting in a quantifiable improvement in the laryngeal view.

Resumo Justificativa: A ventilação difícil ou impossível via máscara facial complicada pela intubação traqueal difícil durante a indução da anestesia ocorre em 0,4% dos casos de anestesia em adultos, possivelmente leva a complicações fatais. Devido a tais catástrofes, recomendou-se que a administração de relaxantes musculares seja feita após a confirmação de ventilação adequada via máscara facial, sem uma validação científica sólida dessa conduta. Métodos: Neste estudo observacional, a facilidade de ventilação e os escores de visibilidade em laringoscopia direta antes e após a administração de cisatracúrio foram avaliados em 90 adultos jovens e saudáveis, sem riscos anestésicos e sem intubação difícil prevista, agendados para cirurgias eletivas gerais. Resultados: Antes do relaxamento muscular, 43 pacientes (48%) eram Cormack Grau I, enquanto os 47 (52%) restantes eram ou Cormack Grau II (28, 31%) ou Cormack Grade III (19, 21%). Após o relaxamento muscular com cisatracúrio, o número de pacientes com Cormack Grau I aumentou significativamente de 43 (48%) para 65 (72%) (p = 0,0013). Apenas um paciente (5%) dos 19 melhorou sua classificação de Cormack do Grau III para o Grau I, enquanto 16 dos 19 (84%) melhoraram suas classificações de Cormack do Grau III para o grau II após o uso de cisatracúrio. A qualidade da ventilação via máscara facial não diferiu com ou sem relaxantes musculares em todos os pacientes. Conclusão: O uso de cisatracúrio em adultos jovens saudáveis submetidos a cirurgias eletivas gerais sem intubação traqueal difícil prevista não teve efeito sobre a qualidade da ventilação via máscara facial, mesmo resultando em melhora quantificável da visibilidade da laringe.

[Nondepolarizing muscle relaxant improves direct laryngoscopy view with no effect on face mask ventilation]. / Relaxantes musculares não despolarizantes melhoram a visibilidade em laringoscopia direta sem efeito sobre a ventilação via máscara facial.

BACKGROUND: Difficult or impossible face mask ventilation complicated with difficult tracheal intubation during anesthesia induction occurs in 0.4% of adult anesthesia cases, possibly leading to life-threatening complications. Because of such catastrophes, muscle relaxants have been recommended to be administered after confirming adequate face mask ventilation without a solid scientific validation of this principal. METHODS: In this observational study, the ease of ventilation and the scores of direct laryngoscopy views before and after administration of cisatracurium were assessed in ninety young healthy adults, without anesthetic risks and without foreseen difficult intubation and who were scheduled for general elective surgeries. RESULTS: Before muscle relaxation, 43 patients (48%) were Cormack Grade I, while the remaining 47 patients (52%) were either Cormack Grade II (28 patients, 31%) or Cormack Grade II (19 patients, 21%). Following muscle relaxation with cisatracurium, the number of patients with Cormack Grade I significantly increased from 43 patients (48%) to 65 patients (72%) (p=0.0013). Only 1 patient out of 19 patients (5%) improved his Cormack grade from Grade III to Grade I while 16 out 19 patients (84%) improved their Cormack grade from Grade III to Grade II after the use of cisatracurium. The quality of face mask ventilation did not differ with and without muscle relaxants in all patients. CONCLUSION: The use of cisatracurium in healthy young adults undergoing general elective surgeries with no anticipated difficult endotracheal intubation had no effect on the quality of face mask ventilation despite resulting in a quantifiable improvement in the laryngeal view.

Informational Needs of Women with Breast Cancer Treated with Chemotherapy.

BACKGROUND: Research in the field of informational needs of breast cancer patients is scarce. In the few published articles, these needs were usually not satisfied. The main objective of this study was to evaluate satisfaction regarding informational needs in women with breast cancer. The long-term goal was to guide physician-patient communication to meet these needs. MATERIALS AND METHODS: A survey with 21 questions was completed by 84 female patients receiving chemotherapy in a one-day hospital in Beirut, Lebanon. All patients were aware of their disease and agreed to participate in the survey. RESULTS: The doctor was the major source of information for patients followed by media (radio and television). The level of knowledge of patients concerning their disease was proportional to the number of information sources. Women aged younger than 45 years, diagnosed during the last three months before the survey and certified from high school were less satisfied with information given by the oncologist. The missing information was in relation with the steps of the treatment after the chemotherapy regimen, the risk of a family member (sisters and daughters) of developing the disease and management of lymphedema. CONCLUSIONS: This study generated a scale for the degree of satisfaction of information received by women with breast cancer from their oncologist. The physician can use this scale to improve his or her skills of communication to patients and diminish their level of fear and anxiety.

Supplementation of retrobulbar block with clonidine in vitreoretinal surgery: effect on postoperative pain.

STUDY OBJECTIVE: To evaluate the effect of clonidine when added to local anesthetics on duration of postoperative analgesia during retrobulbar block. DESIGN: Prospective, randomized controlled trial. SETTING: Operating room and Postanesthesia Care Unit of a university-affiliated hospital. SUBJECTS: 80 ASA physical status 1, 2, and 3 patients undergoing vitreoretinal surgery with or without scleral buckling. INTERVENTIONS: Patients in the control group (n = 40) received a retrobulbar block with 4.5 mL of lidocaine-bupivacaine and 0.5 mL of saline. Clonidine group patients (n = 40) received 4.5 mL of lidocaine-bupivacaine and 0.5 µg/kg of clonidine in a 0.5 mL volume. MEASUREMENTS: The time to first analgesic request, frequency of postoperative pain, and number of postoperative analgesic requests per patient were assessed. MAIN RESULTS: 37 patients in the control group (92.5%) versus 24 patients (60%) in the clonidine group reported pain postoperatively (P = 0.001), with a shorter time to first analgesic request noted in the control group (4.9 ± 3 vs 11.9 ± 5.3 hrs; P < 0.001). The median number of postoperative analgesic requests per patient during the first 24 hours was higher in the control group than the clonidine group [2 (0-3) vs. 1 (0-3); P < 0.001]. CONCLUSIONS: The addition of clonidine 0.5 µg/kg to the local anesthetics of a retrobulbar block for vitreoretinal surgery decreases the frequency of postoperative pain and prolongs the time of analgesia.