A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life.

BACKGROUND: More than 90% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity. AIMS: To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage. METHOD: A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL). FINDINGS: Mean age was 56 years, 60% had an ileostomy, and 40% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (P<0.001), worry about leakage decreased significantly (P<0.001) and QoL improved. CONCLUSION: The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage.

Impact of stoma leakage in everyday life: data from the Ostomy Life Study 2019.

BACKGROUND: Many people with a stoma experience leakage of stomal effluent. AIM: To investigate the impact of leakage on individuals with a stoma. METHODS: The Ostomy Life Study 2019 included a survey concerning experiences with stomal effluent leakage and the validated Ostomy Leak Impact tool. FINDINGS: Respondents with frequent leakage episodes were significantly more affected emotionally and they were feeling less in control than those who rarely or never experienced leakage. The emotional impact of experiencing leakage onto clothes appeared to last up to 1 year after the last leakage incidence. Because of worrying about leakage users increased their product usage and, of those who were in employment, 65% reported that leakage and the related worry influenced their ability to work. CONCLUSION: Most people with a stoma were emotionally impacted by experiencing leakage, especially by leakage outside the baseplate (resulting in soiled clothes). New solutions are warranted that can help reduce the impact of leakage.

Perception of leakage: data from the Ostomy Life Study 2019.

BACKGROUND: Leakage is a common problem for people with a stoma. AIM: To investigate how people with a stoma and stoma care nurses perceive different patterns of effluent under the baseplate. METHODS: The Ostomy Life Study 2019 included a user survey and a nurse survey covering experiences of leakage and the perception of leakage. FINDINGS: Most people with a stoma perceived effluent reaching outside the baseplate as leakage (88-90%), whereas effluent close to the stoma only was not perceived as leakage by the majority (81-91%). Effluent covering major parts of the baseplate was perceived as leakage by most respondents with a colostomy or ileostomy (83%), whereas fewer respondents with a urostomy perceived this as leakage (57%). Most of the nurses (70%) did not perceive effluent close to the stoma as leakage. CONCLUSION: This study revealed that effluent confined to the area next to the stoma is generally not perceived as leakage.

Evaluation of a new ostomy mouldable seal: an international product evaluation.

A new mouldable seal, Brava® Protective Seal, was evaluated by patients on aspects related to residue, durability, and preference. A total of 135 patients from four countries participated (Denmark, Germany, Japan and the USA) and the new product was compared to the patients' usual pouching systems. Less residue and easier skin cleansing was observed, which may benefit patient quality of life. The possible benefits of less residue for peristomal skin health need further investigation.

Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial.

Background: Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside the baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance, peristomal skin complications, feeling unable to cope, and self-isolation. Method: An interventional, single-arm, multi-centre study was undertaken in the United Kingdom to evaluate a novel digital leakage notification system for ostomy care, including a support service (=test product) for 12 weeks in patients with a recent stoma formation (≤9 months). Patients completed questionnaires at baseline and after 4, 6, 8, 10, and 12 weeks, evaluating leakage episodes, Ostomy Leak Impact (tool containing three domains), and patient self-management (by PAM-13). Additionally, mental well-being (by WHO-5) and health-related quality of life (QoL) (by EQ-5D-5L) were assessed. Outcomes between baseline and final evaluation were compared by generalised linear and linear mixed models. Results: 92 patients (ITT population) with a mean age of 49.4 years (range 18-81 years) were recruited. Of these, 80% had an ileostomy, and 53% were female. After 12 weeks of using the test product, a significant decrease in mean episodes of leakage outside the baseplate (1.57 versus 0.93, p < 0.046) was observed. Ostomy Leak Impact scores improved across all three domains (p < 0.001), indicating less embarrassment, increased engagement in social activities, and increased control. Patient self-management also improved significantly (PAM-13 score: ∆6.6, p < 0.001), as did the WHO-5 well-being index (∆8.0, p < 0.001). Lastly, EQ-5D-5L profile scores tended to improve (p = 0.075). Conclusions: A new digital leakage notification system demonstrated strong improvements to patients' stoma self-care, mental well-being, and QoL. Registration number on ClinicalTrials.gov: NCT05135754.

Comparison of associations of maternal peri-pregnancy and paternal anthropometrics with child anthropometrics from birth through age 7 y assessed in the Danish National Birth Cohort.

BACKGROUND: Maternal prepregnancy adiposity may influence child adiposity beyond the transmitted genetic effects, which, if true, may accelerate the obesity epidemic, but the evidence for this mechanism is inconsistent. OBJECTIVE: The aim was to assess whether the associations of maternal body mass index (BMI) with child anthropometric measurements from birth through infancy and at 7 y of age exceed those of paternal associations. DESIGN: In the Danish National Birth Cohort, information on parental and child anthropometric measures is available for 30,655 trio families from maternal interviews during pregnancy and the postpartum period and from a 7-y follow-up. By using multiple linear and logistic regression models of child SD (z) scores of weight and BMI at birth, 5 mo, 12 mo, and 7 y of age, and of child overweight at age 7 y, we compared associations with maternal prepregnancy and postpartum BMI z scores and with paternal BMI z scores. RESULTS: When comparing maternal-child and paternal-child BMI z score associations, the strongest associations were observed with mothers' BMI at birth [maternal and paternal BMI z scores: 0.143 (95% CI: 0.130, 0.155) and 0.017 (95% CI: 0.005, 0.029), respectively] and throughout infancy, but the relative difference in the associations declined by child age [for BMI z score at child age 7 y per maternal and paternal BMI z scores: 0.208 (95% CI: 0.196, 0.220) and 0.154 (95% CI: 0.143, 0.166), respectively]. At 7 y of age, ORs of child overweight were 2.30 (95% CI: 1.99, 2.67) by maternal overweight and 1.96 (95% CI: 1.74, 2.21) by paternal overweight. There were no differences between the results based on maternal BMI before and after pregnancy or on child's weight adjusted for length or height. CONCLUSIONS: The associations of child weight and BMI with maternal BMI were stronger than with paternal BMI. The differences between the associations were strong at birth but declined with child aging.

Long-term risk of cardiovascular and cerebrovascular disease after removal of the colonic microbiota by colectomy: a cohort study based on the Danish National Patient Register from 1996 to 2014.

OBJECTIVES: The hypothesis of the study was that if the gut microbiota is involved in the development of atherosclerotic cardiovascular and cerebrovascular diseases (CVDs), total colectomy may reduce the long-term risk of CVDs. The aim was therefore to investigate the risk of CVD in patients after a total colectomy compared with patients undergoing other types of surgery, which are not expected to alter the gut microbiota or the CVD risk. SETTING: The Danish National Patient Register including all hospital discharges in Denmark from 1996 to 2014. PARTICIPANTS: Patients (n=1530) aged 45 years and above and surviving 1000 days after total colectomy without CVDs were selected and matched with five control patients who were also free of CVD 1000 days after other types of surgery. The five control patients were randomly selected from each of the three surgical groups: orthopaedic surgery, surgery in the gastrointestinal tract leaving it intact and other surgeries not related to the gastrointestinal tract or CVD (n=22 950). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the first occurring CVD event in any of the seven diagnostic domains (hypertensive disorders, acute ischaemic heart diseases, chronic ischaemic heart disease, cardiac arrhythmias, heart failure, cerebrovascular diseases and other arterial diseases) and the secondary outcomes were the first occurring event within each of these domains. RESULTS: Estimated by Cox proportional hazard models, the HRs of the composite CVD end point for patients with colectomy compared with the control patients were not significantly reduced (HR=0.94, 95% confidence limits 0.85 to 1.04). Among the seven CVD domains, only the risk of hypertensive disorders was significantly reduced (HR=0.85, 0.73 to 0.98). CONCLUSIONS: Colectomy did not reduce the general risk of CVD, but reduced the risk of hypertensive disorders, most likely due to salt and water depletion induced by colectomy. These results encourage a reappraisal of the associations between gut microbiota and CVD.

Risk of childhood overweight after exposure to tobacco smoking in prenatal and early postnatal life.

OBJECTIVE: To investigate the association between exposure to mothers smoking during prenatal and early postnatal life and risk of overweight at age 7 years, while taking birth weight into account. METHODS: From the Danish National Birth Cohort a total of 32,747 families were identified with available information on maternal smoking status in child's pre- and postnatal life and child's birth weight, and weight and height at age 7 years. Outcome was overweight according to the International Obesity Task Force gender and age specific body mass index. Smoking exposure was categorized into four groups: no exposure (n = 25,076); exposure only during pregnancy (n = 3,343); exposure only postnatally (n = 140); and exposure during pregnancy and postnatally (n = 4,188). Risk of overweight according to smoking status as well as dose-response relationships were estimated by crude and adjusted odds ratios using logistic regression models. RESULTS: Exposure to smoking only during pregnancy, or both during pregnancy and postnatally were both significantly associated with overweight at 7 years of age (OR: 1.31, 95% CI: 1.15-1.48, and OR: 1.76, 95% CI: 1.58-1.97, respectively). Analyses excluding children with low birth weight (<2,500 gram) revealed similar results. A significant prenatal dose-response relationship was found. Per one additional cigarette smoked per day an increase in risk of overweight was observed (OR: 1.02, 95% CI: 1.01-1.03). When adjusting for quantity of smoking during pregnancy, prolonged exposure after birth further increased the risk of later overweight in the children (OR 1.28, 95% CI:1.09-1.50) compared with exposure only in the prenatal period. CONCLUSIONS: Mother's perinatal smoking increased child's OR of overweight at age 7 years irrespective of birth weight, and with higher OR if exposed both during pregnancy and in early postnatal life. Clear dose-response relationships were observed, which emphasizes the need for prevention of any tobacco exposure of infants.

Maternal Distress during Pregnancy and Offspring Childhood Overweight.

Background. Maternal distress during pregnancy increases the intrauterine level of glucocorticoids, which may have long-term health consequences for the child. Objective. To examine if distress as a combined measure of anxiety, depression, and stress of the mother during pregnancy was associated with offspring childhood overweight at age 7. Methods. We performed a cohort study using prospective data from 37,764 women and child dyads from the Danish National Birth Cohort (1996-2002). At a telephone interview at approximately 30 weeks gestation, the women reported whether they felt anxious, depressed, or stressed. The 95 percentile for body mass index in an international reference defined childhood overweight at any given age. Logistic regression was used for the analyses. Results. The prevalence of overweight children at 7 years of age was 9.9%. Prenatal exposure to maternal distress during pregnancy was not associated with childhood overweight at 7 years of age (adjusted OR 1.06 (95% CI 0.96; 1.18)). In analyses stratified on sex, a small tendency of overweight was seen in boys (OR 1.15 (0.99; 1.33)), but not in girls (OR 0.98 (0.85; 1.13)). Conclusions. Maternal distress during pregnancy appeared to have limited, if any, influence on the risk of overweight in offspring at 7 years of age.