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

Creation of a stoma can be lifesaving for patients suffering from, for example, colorectal cancer, Crohn's disease, diverticulitis or ulcerative colitis (Burch, 2005). However, living with a stoma can cause difficulties in coping with everyday life, where presence of odour, participation in sports, alteration in sleep habits and the need for further treatment have been identified as concerns for stoma patients (Richbourg et al, 2007; Claessens et al, 2015). Leakage of stomal effluent or worrying about the possibility of leakage have been identified as key determinants for reduced physical and psychosocial wellbeing of people living with a stoma (Claessens et al, 2015; Hedegaard et al, 2020). Leakage of stomal effluent is a common problem for people with a stoma and in surveys conducted in the past decade, with less than 20% reporting never experiencing episodes of leakage (Porrett et al, 2011; Hedegaard et al, 2020).

Two broad definitions of leakage have recently been implemented, namely ‘leakage underneath the baseplate’ and ‘leakage outside the baseplate (eg, onto clothes or onto bed)’(Nafees et al, 2018). In the present Ostomy Life Study 2019, most respondents (76%) experienced leakage of stomal effluent underneath the baseplate at least once every month, and 65% had experienced stoma effluent leakage outside baseplate and/or onto clothes at least once in the previous year, with 26% experiencing this on a monthly basis or more frequently. Only 14% of respondents experienced leakage outside the baseplate and/or onto clothes less than once a year (Anne Steen Hansen, personal communication).

Leakage of stomal effluent underneath the baseplate and onto skin has been identified as one of the key factors for experiencing peristomal skin complications (PSCs) (Voegeli et al, 2020). The higher the frequency of leakage of stomal effluent underneath the baseplate and onto skin, the greater the risk of developing PSCs (Voegeli et al, 2020). In the diagnosis of PSCs, up to 77% of cases have been associated with the contact of stomal effluent to the skin (Herlufsen et al, 2006), where moisture and digestive enzymes from faecal effluent are the most important risk factors for compromising the skin barrier (Bohe et al, 1983; Andersen et al, 1994; Gray et al, 2013). In a recent survey, up to 88% of participants suffered from PSCs (Fellows et al, 2021).

Leakage of stomal effluent and PSCs are interconnected with the quality of life (QoL) of people living with a stoma (Pittman et al, 2008). People with frequent episodes of leakage underneath the baseplate have lower QoL scores than those who rarely or never experience leakage (Davis et al, 2011; Hedegaard et al, 2020). Furthermore, people with PSCs have lower QoL scores than those without PSCs (Erwin-Toth et al, 2012; Hedegaard et al, 2020) and the severity of the PSC correlates with a greater negative impact on QoL (Nybaek et al, 2010; Goldstine et al, 2019; Nichols et al, 2019). Finally, people experiencing leakage episodes onto clothes have lower QoL scores than people only experiencing leakage underneath the baseplate (Nafees et al, 2018).

Although it is known that leakage outside of the baseplate and onto clothes has an immediate impact on those who experience it (Nafees et al, 2018), and that more than 90% of people with a stoma worry about leakage (Claessens et al, 2015), not enough is currently known about the societal impact of leakage on, for example, an individual's productivity, ability to work, sleeping habits and for how long someone is impacted by an episode of leakage. The aim of the present study was to investigate how people are impacted by leakage in everyday life.

Methods

Ostomy Life Study 2019

The Ostomy Life Survey 2019 was an online, retrospective, self-reported questionnaire that was developed by Coloplast A/S (Fellows et al, 2021). A total of 54 614 individuals living with a stoma from 17 countries (the USA, Canada, Brazil, China, Australia, Japan and 11 countries in Europe) were invited to participate in the study. Participants were randomly selected from local Coloplast A/S databases with stratified sampling to reflect each country's market size. Before answering the survey, all participants consented to taking part and allowed Coloplast A/S to use the collected, aggregated and anonymous data for internal and publication purposes.

The survey contained questions regarding demographics, such as participants' age, gender, and years with a stoma, as well as users' self-reported leakage incidents and the consequences of those. The types of leakages were described to the respondents prior to the part of the survey that asked about leakage incidences and the impact of leakage. Leakage was defined as either stomal effluent observed underneath the baseplate during appliance change or as stomal effluent outside the baseplate (eg, onto clothing). People with a urostomy were not presented with questions concerning faecal consistency. Impact of leakage on everyday life for people living with a stoma was investigated using the validated Ostomy Leak Impact (OLI) tool (Nafees et al, 2018). People irrigating their stoma were not presented with this specific part of the survey, since they do not experience leakage to the same degree as those who do not irrigate their stoma. Every question had predefined response options, which are highlighted in the legend for each of the figures presented in this article. Some questions had the option ‘other reason’ coupled with the opportunity to write an individual answer.

Exclusion criteria for using an individual questionnaire in the analysis were: if all questions were answered within 15 minutes (the survey was estimated to take 30 minutes to complete), if more than 30% of the answers were ‘don't know’ or if the participant did not finish the survey.

Statistics

The data were collected and processed using Microsoft Excel. Statistical analyses were performed using GraphPad Prism (v9.0.0 for Windows).

Fisher's exact tests were performed to analyse the relationship of use of supporting product with subjects' degree of worry about leakage. To account for multiple comparisons using Fisher's exact tests, Bonferroni correction of the P-values was used. One-way analysis of variance (ANOVA) followed by Dunnett's multiple comparisons test or unpaired, two-sided t-tests were performed to analyse the relationship between the time since surgery and impact of leakage, as well as leakage incidence and impact of leakage.

Results

Demographics of respondents

Out of the 54 614 people with a stoma invited to participate in the survey, a total of 5187 completed the initial survey. People who did not irrigate their stoma were further invited to complete a questionnaire concerning leakage and peristomal skin complications (n=4209). Of the participants, 56% were male and 62% were aged 60 years or older (Table 1). Regarding employment status, 27% of respondents worked either full time or part time, and 51% were retired.

In terms of stoma type, 39% had a colostomy, 41% had an ileostomy or jejunostomy and 21% had a urostomy; 3% of the respondents reported having more than one stoma. Many of the respondents had had their stoma for more than 10 years (30%), and only 16% had had their stoma surgery within the previous 12 months (Table 1).

Most people living with a stoma worry about leakage

Based on a five-level scale, ranging from ‘very high’ degree to ‘not at all’, 92% of participants worried about leakage to varying degrees and only 8% did ‘not at all’ worry about leakage (Figure 1a). Concerningly, 39% of respondents reported worrying about leakage to a ‘high’ or ‘very high’ degree (Figure 1a). Unsurprisingly, the worry about leakage positively correlated with the frequency of leakage underneath the baseplate and/or onto clothes.

A significantly larger proportion of people who had had their stoma formed within the previous year worried to a ‘very high’ degree about leakage (26%) than those who had had their stoma for more than 1 year (19%) (P<0.01) (Figure 1b).

Stoma effluent consistency also had an impact to the degree of worry. For people with faecal stomas, those with liquid effluent worried more about leakage (‘very high’ and ‘high’ degree: 49% of respondents) compared with people having mushy effluent (‘very high’ or ‘high’ degree: 39% of respondents) (P<0.001). Likewise, people having mushy effluent worried more about leakage than people with firm effluent (‘very high’ or ‘high’ degree: 32% of respondents) (P<0.05) (Figure 1c). The proportion of people with a urostomy worrying about leakage to a ‘very high’ or ‘high’ degree was 35%.

Of those who were employed, 65% reported that the experience of leakage and/or the worry regarding it influenced their ability to work or to attend work (to any degree). Specifically, 15% of respondents reported being either ‘highly’ affected or affected to such a degree that it ‘completely prevented’ them from working (Figure 1d).

Risk of leakage has emotional and social implications

When asked about the emotional and social implications of leakage and the associated worry, 45% of the respondents felt they were able to cope ‘all the time’, however, 25% indicated that they only ‘sometimes’, ‘rarely or never’ were able to cope with their situation (Figure 2). The majority (64%) of the respondents felt they were ‘often’ or ‘all the time’ in control of their situation with regard to leakage and the risk of leakage, whereas the remainder at best ‘sometimes’ (21%), ‘rarely or never’ (16%) felt in control.

Due to the risk of leakage 72% of respondents (‘sometimes’, ’often’ or ’all the time’) kept checking the pouching system for leakage. Even during night more than half of the respondents ‘sometimes’(28%), ’often’ (16%) or ’all the time’(10%) indicated that they kept waking up to check the pouching system due to the risk of leakage.

Regarding contact and interaction with other people, 20% of the respondents indicated that the risk of leakage made them decide to stay at home ‘often’ or ‘all the time’ and even made 13% of respondents avoid other people ‘often’ or ‘all the time’. The risk of leakage also led to 15% to avoid close physical contact with family and friends ‘often’ or ‘all the time’ (Figure 2).

People worrying about leakage use more products

Due to the worry about leakage more than half of the respondents reported increased product usage; 54% of the respondents changed their appliance more often and 52% reported using supporting products (accessories) (Figure 3a). Approximately one-quarter (23%) of respondents sought advice from stoma care nurses when they worried about leakage, with fewer seeking advice from the manufacturer (10%), online (8%) or from their peers (6%). Worry about leakage made 11% of the respondents try a different brand of stoma appliances. It is notable that almost three out of ten (29%) of the respondents simply accepted living with their worry about leakage.

The use of different supporting stoma products within the previous month was clearly impacted by the degree to which people worried about leakage. In general, the greater the worry about leakage, the more supporting products had been used (Figure 3b). For example, 52% of respondents worrying about leakage to a ‘very high’ degree had used tape within the past month, whereas only 19% of respondents that did ‘not at all’ worry about leakage had used tape (P<0.0001). Furthermore, 48% of respondents worrying about leakage to a ‘very high’ degree had used rings or seals within the past month, but only 27% of respondents who did ‘not at all’ worry about leakage had used rings or seals (P<0.0001). The correlation between worry about leakage and consumption of supporting products, especially rings, seals and tape, were similar for people with a urostomy and people with faecal stomas.

Impact of leakage increases with the frequency of leakage episodes

Leakage impact was measured by the OLI tool (Nafees et al, 2018) to assess the burden of leakage and to investigate if the frequency of leakage underneath the baseplate or onto clothes had an impact on QoL of people living with a stoma. The OLI tool summarises the burden of leakage in three domains: ‘emotional impact’, ‘usual and social activities’ and ‘coping and control’, with each domain having a range of 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact.

The impact of leakage located only underneath the baseplate increased with the frequency of leakage episodes; the more frequent the episodes, the greater the negative impact across all three domains (Figure 4a). People experiencing leakage underneath the baseplate only once a month still had a significantly reduced QoL scores in two of the three domains, namely ‘emotional impact’ and ‘usual and social activities’.

Similarly, the more frequent the episodes of leakage onto clothes, the greater the negative impact across all three domains (Figure 4b), particularly for people experiencing leakage onto clothes within the previous 3 months. People experiencing episodes of leakage onto clothes less than once a year did not appear to be negatively impacted in either of the three leakage impact domains. In contrast, for people experiencing weekly episodes of leakage onto clothes the impact scores dropped considerably. For example, people with weekly episodes of leakage onto clothes had almost half the score (42) in the ‘emotional impact’ domain compared with people never experiencing leakage onto clothes having a score of 83.

When comparing the impact of having leakage episodes underneath the baseplate with episodes of leakage onto clothes (experienced within the past month), the negative impact on ‘emotional’, ‘usual and social activities’ and ‘coping and control’ domains were significantly greater for leakage onto clothes than for leakage underneath the baseplate (P<0.001 for all domains) (Figure 5).

New stoma patients experience greater burden of leakage

In the population of this study, approximately 16% had recently (within 1 year) had their stoma surgery, whereas almost 30% had had their stoma for more than 10 years (Table 1). People who had had surgery in the past year had significantly lower OLI scores in all three domains compared with people who had had their stoma for more than 10 years. Even people with stoma surgeries 3 or 4 years previously still had significantly reduced impact scores in the ‘coping and control’ domain, meaning they, for example, were less able to cope with their situation and felt less in control (Figure 6).

Those with recent stoma surgery experienced significantly higher levels of weekly episodes of leakage onto clothes (16%) compared with people who had had their stoma for longer than 1 year (7%) (P<0.0001).

Discussion

The purpose of this study was to investigate how people living with a stoma were impacted in their everyday life by incidents of leakage (underneath the baseplate or onto clothes) and the worry regarding this.

We found that the vast majority (92%) of respondents in the study worried about leakage of stomal effluent, and that this worry affected their daily lives, such as their ability to work. Two-thirds (65%) of the employed respondents were affected in their ability to work to varying degrees. The consequences of leakage and the worry about it were manifold, with more than half reporting that they were unable to cope with their situation from time to time. More than one-third of respondents ‘never’ or only ‘sometimes’ felt in control of their situation and over half of the respondents reported trouble sleeping. Additionally, respondents worrying about leakage also reported various forms of isolation, for example, ‘always’ or ‘often’ staying at home (20%), ‘always’ or ‘often’ avoiding people (13%) or ‘always’ or ‘often’ avoiding physical contact with family and friends (15%). Reports of ‘worrying about leakage’ have remained consistently high during the past decade with: 91% in 2014 (Claessens et al, 2015), 93% in 2016 (unpublished data collected as part of the Ostomy Life Study 2016) and 92% in the present survey, indicating that current stoma care products do not sufficiently address and eventually limit the issue of worrying about leakage.

Not surprisingly, the impact of leakage, as measured using the OLI tool (Nafees et al, 2018), was found to be greater for people with higher frequencies of leakage incidents, and leakage outside the baseplate (eg onto clothes) had a greater negative impact than leakage underneath the baseplate, supporting previous studies using various stoma-related QoL tools (Pittman et al, 2008; Davis et al, 2011; Erwin-Toth et al, 2012; Nafees et al, 2018; Hedegaard et al, 2020). The present study also revealed that people who had had their stoma formed within the previous year scored significantly lower in all three domains of the OLI tool compared with people who had had their stoma for more than 10 years, as previously reported (Davis et al, 2011). A contributing factor for this observation may be that a higher proportion with recent stoma surgery (<1 year) experienced weekly episodes of leakage onto clothes compared with people who had had their stoma for longer than 1 year, suggesting that newly operated people with a stoma have not yet acquired proper routines for pouching system changes or not yet found a proper fitting pouching system.

Worry about leakage led the respondents to take different actions to mitigate the risk of leakage. For example, more than half the respondents changed their appliance more often and/or used more supporting products. In particular, those who worried to a ‘high’ or ‘very high’ degree used significantly more supporting products, such as rings, seals, paste, tape, belt and powder, compared with people who did ‘not at all’ worry about leakage.

The present study furthermore revealed that worrying about leakage positively correlated with the frequency of leakage incidents. Effluent under the baseplate is also associated with the risk of experiencing PSCs (Voegeli et al, 2020), and people experiencing leakage have significantly higher treatment costs of PSCs compared with individuals rarely troubled by leakage (Martins et al, 2012; Meisner et al, 2012). Furthermore, those who were burdened by PSCs have a significant impact on the use of healthcare resources (Taneja et al, 2017). Besides an increased use of supporting products (Voegeli et al, 2020), people with PSCs are more likely to be readmitted to hospital (Taneja et al, 2019), and more than one-third of the visits to stoma care nurses are related to alleviating the burden of PSCs (Jemec et al, 2008).

In addition to the direct use of healthcare resources, approximately two out of three respondents who were employed reported being affected to varying degrees in their ability to work due to leakage of stomal effluent or the worry regarding it. Previous studies have shown that stoma surgery and the care required may have a negative impact on the ability to work for some individuals, potentially forcing a change in occupation (Martinsson et al, 1991; Nichols et al, 2008; Davis et al, 2020).

Adding to this, people living with a stoma have significantly more sick leave during the year, leading to substantial annual productivity losses (Rethmeier et al, 2018).

Leakage of stomal effluent is interconnected with PSCs and the QoL of people living with a stoma (Pittman et al, 2008). Stoma care nurse consultations have been shown to help reduce the incidence of leakage and PSCs (Porrett et al, 2011), which again has been associated with improvement in QoL scores (Erwin-Toth et al, 2012). This suggests that implementing initiatives that can reduce the incidence of leakage and subsequently the worry about leakage may both improve QoL of people with a stoma, reduce PSCs, reduce healthcare costs, and potentially increase work productivity. Considering that the proportion of individuals who worry about leakage has remained consistently high during the past decade, new solutions are warranted that can help people with a stoma to identify leakage when it appears and thereby ensure timely changes of the pouching system before leakage under the baseplate progresses beyond the baseplate and onto clothes.

Limitations

Limitations of the present study include that the data were self-reported and not collected by health professionals as part of a clinical study. The respondents were recruited from Coloplast A/S databases, indicating that they were using or had previously used Coloplast A/S products. The population included in the study may therefore not be completely representative of people who use stoma devices. However, there is no reason to believe that the prevalence and numbers affected by leakage and its consequences in everyday life should be worse for the present population compared with a population not using Coloplast A/S appliances. Thus, prevalence and numbers are not expected to be systematically biased.

The respondents of the survey were dominated by individuals aged 60 years or above (62%) and only about 27% were in employment. The bias towards elderly and retired respondents warrants further analysis of how those working and who are younger are burdened by leakage and worry about it.

The survey was sent out to 17 countries and thus provides a good representation of the global population in ostomy care. However, the present study did not consider national differences in stoma care in the analysis, meaning that these differences could potentially influence the results. Additional analysis of the data could investigate national differences in results regarding population differences and standard of care.

Finally, the response rate to the survey was low (9.5%), which may be due to a lack of interest in the topics of the survey or because the research was conducted online only, meaning that those not comfortable with using online media were not represented in the survey.

Conclusion

This survey revealed that most people living with a stoma are adversely impacted by leakage of stomal effluent and the worry regarding it, with effects on their emotion and on normal daily activities and social activities. New stoma patients experienced more weekly episodes of leakage onto clothes and this group of patients also showed reduced QoL and increased worry about leakage compared with those who had had their stoma for longer than 1 year. Those worrying the most about leakage had an increased consumption of supporting products. To combat the impact that leakage has on people with a stoma, multiple initiatives are needed, targeting both nurses and users, in order to increase leakage awareness, and to identify training and support needs in good product and appliance change routines. Moreover, development of new technical solutions that can help people with a stoma to identify leakage when it appears and before it progresses onto clothes would potentially be of great benefit to help reduce users' worry about leakage.

KEY POINTS

• In the Ostomy Life Survey 2019, 92% of participants, who were all living with a stoma, worried about leakage
• Of the respondents who were working, 65% were affected in their ability to work by leakage of stomal effluent or the worry regarding this
• Individuals living with a stoma who worried about leakage used more supporting products
• The psychosocial impact of leakage increased with the frequency of leakage episodes
• Leakage outside the baseplate (onto clothes) had greater impact on psychosocial wellbeing than leakage underneath the baseplate only

CPD reflective questions

• Why do you think that worry about stoma leakage has remained consistently high in the past decade among people living with a stoma?
• Which actions do nurses and people with a stoma take to help minimise the worry of leakage?
• How do you prepare new stoma patients to cope with leakage in everyday life to help ensure that leakage has minimum impact on emotional wellbeing, work, social life and intimacy?