Up to 1 million people in the USA and approximately 700 000 in Europe live with a stoma (Eucomed Medical Technology, 2012; United Ostomy Associations of America, 2018). An intestinal stoma is the result of a surgical procedure undertaken to eradicate disease and/or relieve symptoms in patients with colorectal and/or bladder cancer, Crohn's disease, ulcerative colitis, and other diseases affecting the bowel (Strong, 2017; Qureshi et al, 2018; Müller et al, 2020). Other conditions that may require the formation of a stoma include diverticulitis, familial polyposis and traumatic injuries (Burch, 2005). Stoma creation is usually a life-changing event (Scheidbach et al, 2009), requiring physical adjustments with accompanying emotional, social, and psychological effects (Brown and Randle, 2005). Individuals may adapt differently to these effects based on their stoma type, age, gender and other factors (Ma et al, 2007; Salvadalena, 2008; Grant et al, 2011; Danielsen, 2013). Particular concerns include peristomal skin problems, daily activity limitation, inability to participate in sporting or social activities, increased awareness of body image, and fear of leakage and odour (Pieper and Mikols, 1996; Danielsen, 2013). A previous survey found that 76% of the 4138 participants had experienced leakage over 6 months, while 91% worried about leakage (Claessens et al, 2015). Leakage of stomal output onto the skin can cause peristomal skin complications, resulting in greater use of stoma accessories and more frequent contact with health professionals, which subsequently increase healthcare costs (Meisner et al, 2012; Voegeli et al, 2020).
The process of adapting to a stoma is complex, and it can take time for individuals to acquire the practical skills necessary for stoma management (Metcalf, 1999; Di Gesaro, 2012). Psychological adjustment may be affected if these skills are deficient or if there are leakage/skin complications (Metcalf, 1999). Stoma care nurses use different strategies, including teaching practical skills, to facilitate psychological adjustment in patients after stoma surgery (Metcalf, 1999; O'Connor, 2005), however, many continue to experience psychosocial problems and feelings of stigma (Danielsen et al, 2013). The Ostomy Life Study 2019 was an online survey conducted with the aim of gaining a better understanding of the experiences, worries and daily challenges faced by people living with a stoma and to obtain data on peristomal body profiles, leakage, peristomal skin complications, physical and social activities, and access to stoma care nurses.
Methods
Study design and participants
The Ostomy Life Study 2019 was an online survey undertaken over 4 months involving people with stoma from 17 countries (Australia, Brazil, Canada, China, Japan, US, and 11 European countries). In each country, the participants were randomly selected from local Coloplast databases without restriction on age, sex, nationality, or stoma type. Stratified sampling was used reflecting the market size for ostomy in each country. Therefore, the number of individuals selected to participate differed across the countries; a response rate of around 20% was anticipated, and the target sample size was 42 000 individuals.
The selected individuals received an online invitation by email or via the WeChat platform (China only) to participate. Each willing participant provided consent to Coloplast A/S online before receiving the survey. Both the invitation and the survey questionnaire were translated into the local language. In addition, in some countries (Denmark, France, Germany, UK, and USA), members of a Coloplast online panel (CORE), consisting of people living with a stoma, were invited to participate in the survey.
The survey topics included questions on the demographics (sex, age, race) and peristomal body profile of the respondents, stoma shape (size and protrusion) and fit, leakage prevalence and peristomal skin complications, physical and social activities, and access to a stoma care nurse. For each topic, the respondents were asked questions related to their experiences and worries, as well as the impact on their daily lives. The response options were mostly predefined; however, some questions allowed for individual comments. Questions were filtered such that each respondent received only questions relevant to them. To gauge the understanding of leakage among the respondents, different pictures of baseplates with faeces (for colostomy or ileostomy patients) or urine (urostomy patients) were shown, illustrating different levels of leakage (Down et al, 2021). Individuals undergoing colostomy irrigation did not receive the questions concerning leakage or peristomal skin complications.
Ethics
No ethics approval was required for this study (which was based on market research) according to the UK NHS Research Ethics Committee decision tool. The participants all consented to receive survey questionnaires from Coloplast A/S, who conducted the survey, and to the use of their data in the analyses. The participants' data were treated with confidentiality in compliance with the European Union General Data Protection Regulation, and data analysis was performed with aggregated anonymous data.
Data analysis
During data processing, the answer ‘don't know’ was replaced with a missing value. Those who did not complete the survey or had missing values on more than 30% of the questions were excluded from the data analysis.
The data were described using frequencies and percentages. Comparisons between different categories were made using Fisher's exact test. Odds ratios (ORs) for experiencing leakage were estimated by comparing categories with respect to dichotomous leakage outcomes, for example, presence/absence of leakage within 1 week/month/year. Statistical analyses were performed using SAS JMPv13.1.0 (SAS Institute Inc., Cary, NC, USA).
Results
Participant profile
Of the 54 614 individuals invited, 5187 responded (overall response rate 9.5%). The response rate varied among the countries and was higher among the CORE panel (range: 35–63%, depending on the country) than the local databases (2–25%). Approximately 19% (n=978) of the respondents underwent colostomy irrigation and were excluded from the leakage-specific subgroup (n=4209) analyses.
Overall, 56% of the respondents were male, 61% were aged 60 years or older, around 60% were white, around 25% were employed full- or part-time (51% retired), and 62% said that they refrained from certain physical and social activities (eg travelling, sports, visiting friends) because of their stoma. More detailed demographics have previously been published (Fellows et al, 2021).
Stoma and peristomal body profile characteristics
In the overall population, 48.4% had a colostomy; 32% had an ileostomy or jejunostomy; and 15.4% had a urostomy; 152 respondents reported having more than one stoma type. In the leakage subgroup, the percentages were 36.7%, 40%, and 19%, respectively. Overall, 19% of the respondents had had their stoma surgery in the preceding 12 months while 52% had it 5 years or more earlier. Overall, when participants were asked to describe their stomas, two-thirds were defined them as ‘round-shaped’ (Figure 1a); 75% stomas protruded above the skin surface (range 59–83%, depending on the stoma type) (Figure 1b), and participants reported a regular peristomal body profile for 50% of the stomas (outward: 35%, inward: 13%; Figure 1c). The position of the stomas (at, above, or below the skin level) was almost equally distributed among those with an inward peristomal body profile; however, those with a regular or an outward peristomal body profile mostly had stomas above the skin surface (Figure 1d).
Leakage of stomal effluents and peristomal body profiles
Detection of output under the baseplate and leakage onto clothes were common in the leakage subgroup. In total, 77% of the subgroup respondents reported output under the baseplate (during pouching system change) within the previous month, with 32% reporting such output within the previous week (Table 1). Moreover, leakage onto clothes was experienced by 26% of the respondents within the previous month, 66% in the previous year, 9% in the previous week, and 55% in the previous 6 months.
Table 1. Output under the baseplate or leakage onto clothes according to whether body changes were experienced.
| Frequency | Body changes experienced n (%) | Body changes not experienced n (%) | Comparison P-value | Don't know n (%) |
|---|---|---|---|---|
| Output under baseplate | ||||
| Daily/almost daily | 106 (7.7) | 122 (5.4) | 0.0047 | 28 (5.0) |
| A couple of times per week | 223 (16.3) | 257 (11.3) | 0.0000 | 74 (13.1) |
| About once per week | 198 (14.5) | 255 (11.2) | 0.0043 | 70 (12.4) |
| 2–3 times in the past month | 276 (20.2) | 444 (19.5) | 0.6366 | 111 (19.6) |
| Once within the past month | 300 (21.9) | 619 (27.2) | 0.0004 | 111 (19.6) |
| Never | 250 (18.3) | 554 (24.3) | 0.0000 | 148 (26.2) |
| Don't know | 15 (1.1) | 25 (1.1) | 1 | 23 (4.1) |
| Total responses | 1368 | 2276 | 565 | |
| Leakage onto clothes | ||||
| At least once per week | 161 (11.8) | 147 (6.5) | 0.0000 | 59 (10.4) |
| At least once per month | 277 (20.2) | 368 (16.2) | 0.0020 | 98 (17.2) |
| At least once every 3 months | 222 (16.2) | 315 (13.8) | 0.0535 | 76 (13.5) |
| At least once every 6 months | 187 (13.7) | 336 (14.8) | 0.3800 | 57 (10.1) |
| At least once per year | 126 (9.2) | 269 (11.8) | 0.0154 | 52 (9.2) |
| Less than once per year | 185 (13.5) | 360 (15.8) | 0.0615 | 60 (10.6) |
| Never | 200 (14.6) | 453 (19.9) | 0.0000 | 135 (23.9) |
| Don't know | 10 (0.7) | 28 (1.2) | 0.1789 | 28 (5.0) |
| Total responses | 1368 | 2276 | 565 | |
Data are presented for the subgroup of respondents who received leakage questions (n=4209). Comparisons between the proportions of respondents in each group were made using Fishers exact pairs test. Statistically significant P values are shown in bold
Stoma type
Output under the baseplate was more prevalent among patients with faecal stomas than in those with urostomies; leakage onto clothes for each stoma type is shown in Figure 2a. The odds of experiencing output under the baseplate on a weekly and monthly basis were significantly greater for respondents with faecal stomas than those with urostomies (OR: 1.4–2.3) and for respondents with ileostomies than those with colostomies (OR: 1.2 and 1.6). Respondents with urostomies also had significantly greater odds of never experiencing output under the baseplate than those with faecal stomas (OR: 1.5−2.3).
In contrast, respondents with ileostomies or urostomies had significantly higher odds of leakage onto clothes monthly and yearly than those with colostomies (OR: 1.3−1.9); furthermore, experiencing leakage onto clothes monthly was the only time interval where the odds of this happening was significantly greater for respondents with ileostomies than those with urostomies (OR: 1.3).
Stoma shape
Respondents with irregular stoma shapes, which constituted 7% of the stomas overall (Figure 1a), tended to have significantly higher odds of experiencing output under the baseplate weekly and monthly (OR: 1.6–2.0) than those with round or oval-shaped stomas (Figure 2b). However, the odds of experiencing leakage onto clothes weekly and monthly were significantly greater for respondents with oval or round stomas than those with irregular stomas (OR: 1.4−2.2).
Stoma position
Respondents with stomas that were level with or below the skin surface had significantly higher odds of experiencing output under the baseplate daily, weekly, and monthly than those with stomas protruding above the skin surface (OR: 1.3–2.1; Figure 2c); moreover, respondents with stomas protruding above the skin surface had greater odds of never experiencing output under the baseplate (OR: 1.5 and 2.3, respectively). A similar pattern was observed with leakage onto clothes: respondents with stomas at or below the skin level had significantly greater odds of leakage onto clothes weekly, monthly, and yearly than those with stomas above the skin level (OR: 1.4−2.7).
Body changes and leakage
In both the overall population and the leakage subgroup, approximately one-third of the respondents (32% and 33%, respectively) had experienced a permanent change in shape (such as a bulge) in the area around the stoma or in the abdominal region over the previous 2 years. When split by stoma type, a slightly greater frequency of respondents with a colostomy than either an ileostomy or a urostomy experienced these peristomal body changes (P=0.0295; Figure 3a).
The odds of experiencing output under the baseplate daily/weekly/monthly (OR: 1.4−1.5), or leakage onto clothes weekly/monthly/yearly (OR: 1.4−1.9), were significantly greater for respondents who experienced peristomal body changes than those who did not (Table 1). Overall, 39% of those individuals reporting changes in the area around the stoma ‘fully agreed’/‘agreed’ that they experienced more frequent leakage onto their clothes, while 43% ‘fully agreed’/‘agreed’ that they felt less confident that their stoma product would stay on the body (Figure 3b).
Respondents with an inward peristomal body profile had significantly higher odds of experiencing output under the baseplate daily/weekly/monthly (OR: 1.4−2.4) or leakage onto clothes weekly/monthly/yearly (OR: 1.3−2.2), when compared with individuals having regular and outward peristomal body profiles. Moreover, those with an outward peristomal body profile had significantly higher odds of experiencing output under the baseplate daily/weekly/monthly (OR: 1.2−1.4) as well as leakage onto clothes weekly/yearly (OR: 1.2−1.3) than those having a regular peristomal body profile.
Leakage with superficial creases and deep peristomal folds
In the leakage subgroup, 31% had superficial creases and/or deep folds in the area around the stoma. In these respondents, the odds of output under the baseplate daily/weekly/monthly and that of leakage onto clothes weekly/monthly/yearly were approximately double those of respondents having no such skin irregularities (OR: 1.9–2.3). Significantly fewer respondents with superficial creases or deep peristomal folds than those with no such skin irregularities had never experienced output or leakage (P<0.0001).
Leakage and time since surgery
Most of the respondents reported output under the baseplate to some extent (>70% respondents across groups) or leakage onto clothes at any time (>60% across groups), irrespective of when their surgery had occurred.
Availability of stoma care nurse and fit of stoma product
In the overall population, 69% of the respondents reported having access to a stoma care nurse who could be consulted as needed; of these respondents, 73% were in contact with their nurse at least once a year (Figure 4a). With regard to the fit of the stoma product, the participants were asked about their frequency of contact with a nurse or the use of an online assessment tool to check if their stoma appliance was still the optimal product to fit their body. Altogether, 37% reported never having this ‘body fit check’, whereas 44% reported having this check at least yearly, either by visiting their nurse and/or using an online assessment tool (Figure 4b).
Table 2. Reported superficial creases or deep folds in the area around the stoma and incidence of output under baseplate and leakage onto clothes.
| Frequency | No irregularities (Group A) | Irregularities (Group B) | Comparison | ||
|---|---|---|---|---|---|
| n | Percentage | n | Percentage | P-value | |
| Output under baseplate | |||||
| Daily/almost daily | 137 | 4.7 | 119 | 9.0 | <0.0001 |
| A couple of times per week | 325 | 11.3 | 229 | 17.3 | <0.0001 |
| About once per week | 317 | 11.0 | 206 | 15.6 | <0.0001 |
| 2–3 times in the past month | 560 | 19.4 | 271 | 20.5 | 0.404 |
| Once within the past month | 734 | 25.4 | 296 | 22.4 | 0.0341 |
| Never | 765 | 26.5 | 187 | 14.1 | <0.0001 |
| Don't know | 49 | 1.7 | 14 | 1.1 | 0.132 |
| Total responses | 2887 | 100 | 1322 | 100 | |
| Leakage onto clothes | |||||
| At least once per week | 187 | 6.5 | 180 | 13.6 | <0.0001 |
| At least once per month | 425 | 14.7 | 318 | 24.1 | <0.0001 |
| At least once every 3 months | 400 | 13.9 | 213 | 16.1 | 0.0596 |
| At least once every 6 months | 419 | 14.5 | 161 | 12.2 | 0.0430 |
| At least once per year | 327 | 11.3 | 120 | 9.1 | 0.0310 |
| Less than once per year | 454 | 15.7 | 151 | 11.4 | 0.0002 |
| Never | 622 | 21.6 | 166 | 12.6 | <0.0001 |
| Don't know | 53 | 1.8 | 13 | 0.98 | 0.0442 |
| Total | 2887 | 100 | 1322 | 100 | |
Data are presented for the subgroup of respondents who received leakage questions (n=4209) and reported no irregularities (n=2887) or superficial creases and/or deep folds (n=1322) around their stoma. Those who answered ‘Don't know’ to the question on whether they had skin irregularities (n=277) are not included above. Comparisons between the proportions of respondents in each group (A versus B) were made using Fisher's exact pairs test. Statistically significant P values are shown in bold
Discussion
The Ostomy Life Study 2019 has provided information about the daily lives and concerns of new and experienced individuals living with a stoma. Detection of stoma output under the baseplate and leakage onto clothes were common in these individuals, with as many as 76% of the respondents reporting output under the baseplate and 26% experiencing leakage onto their clothes within the previous month. The prevalence of both output under the baseplate and leakage onto clothes varied according to the stoma type, shape and position. With regard to stoma type, those with faecal output stomas had significantly greater odds of experiencing output under the baseplate (weekly/monthly) when compared with those having urinary stomas. However, the odds for detecting leakage onto clothes (monthly/yearly) were significantly greater for both urostomies and ileostomies than colostomies. With regard to stoma shape, the odds of detecting output under the baseplate (weekly/monthly) were significantly greater for respondents with irregular stomas than those with oval or round stomas. However, the odds of experiencing leakage onto clothes (weekly/monthly) were lower for those with irregular stomas. Regarding position, the odds of detecting both output under the baseplate (daily/weekly/monthly) and leakage onto clothes (weekly/monthly/yearly) were lower for respondents with stomas that were raised above the skin surface than those with stomas at or below the skin surface.
Changes in the area around the stoma or in the abdominal region were found to be common among the respondents; one-third of the respondents experienced a permanent change in shape, such as a bulge, in the previous 2 years, which was significantly more frequent among those with a colostomy than those with either a urostomy or an ileostomy. Such changes in the peristomal area were associated with greater odds of detecting output under the baseplate (daily/weekly/monthly) or leakage onto clothes (weekly/monthly/yearly), and a large proportion of respondents (43%) felt less confident that their stoma product would stay firmly attached to the body due to these body changes. The type of peristomal body profile also influenced whether respondents experienced leakage of stomal effluents; respondents with an inward peristomal body profile had greater odds of experiencing output under the baseplate (daily/weekly/monthly) or leakage onto clothes (weekly/monthly/yearly) than those with regular or outward peristomal body profiles. Finally, most respondents experienced output under the baseplate or leakage under clothes to some extent over time, irrespective of when their stoma surgery had taken place.
A previous Ostomy Life Study found that 76% of respondents had experienced leakage in the previous 6 months (Claessens et al, 2015), which was greater than the 55% observed in the present study. Peristomal skin issues, in terms of either creases or deep folds, were a problem for approximately one-third of the respondents in the present study, and the odds of output under the baseplate daily/weekly/monthly or leakage onto clothes weekly/monthly/yearly were significantly greater in respondents with such skin issues. A previous open-label study in more than 3000 participants found that a higher frequency of leakage at baseline correlated significantly with worse peristomal skin issues (Porrett et al, 2011); similar results were observed in a survey of 198 stoma patients within a community setting (Ratliff, 2014). Peristomal skin irregularities have reported incidence rates of up to 80% (Colwell et al, 2017; Colwell et al, 2019) and are important to manage as they can interfere with the use of the stoma product (Nybaek and Jemec, 2010) and impact quality of life (Simmons et al, 2007; Porrett et al, 2011).
Just under one-third of the respondents in the present study did not have access to a stoma care nurse, and 37% had never had a ‘body-fit’ check by either consulting their stoma care nurse or using an online assessment tool to ensure that their stoma product remained optimal for their body shape (Figure 4b); this indicates the need for further optimisation of stoma care (Rolstad and Erwin-Toth, 2004). It is clear that leakage and peristomal skin irregularities remain among the most important issues affecting the daily lives of ostomy patients (Richbourg et al, 2007; Jansen et al, 2015), and many people with such issues do not seek support even though their quality of life is impacted (Colwell et al, 2019). For example, in the present study, 62% of the respondents avoided a variety of physical and social activities because of their stoma. Recently, an international group of stoma nurse experts developed consensus-based practice guidelines with the aim of decreasing leakage and improving security and confidence with respect to stoma products, with specific focus on the patient's peristomal body profiles (Colwell et al, 2019; James-Reid et al, 2019). Any solution to leakage requires an assessment of the patient; without this, the selection of appropriate products through interaction between the stoma care nurse and the patient is extremely challenging. Changes in the peristomal body profile should also prompt reassessment either by the stoma care nurse or the patients themselves and, since many patients do not have access to such a nurse, the importance of guides and tools for patient self-assessment has been stressed (Colwell et al, 2019). A novel patient-reported instrument that measures the impact of leakage in stoma care has been developed and validated (Nafees et al, 2018), and campaigns on social media aim to promote awareness about life with a stoma in order to challenge stigma around the condition (Frohlich and Zmyslinski-Seelig, 2014).
Conclusion
Leakage under the baseplate of the stoma product and onto clothes remain important concerns for individuals with a stoma. Leakage, which can cause peristomal skin complications, was associated with stoma types and peristomal body profiles and changes in the area around the stoma. The study highlights the need for optimal access to a stoma care nurse and/or validated assessment tools to minimise the leakage of stomal effluents and to provide the necessary care and guidance to improve the quality of life for people with a stoma.
KEY POINTS
- There remain many challenges that people living with a stoma face in their everyday lives and that impact on their quality of life
- People with a stoma commonly experience leakage of stomal effluents from under the baseplate of their stoma product and onto their clothes, which is usually associated with the individual's stoma characteristics and peristomal body profiles
- Optimal access to a stoma care nurse would enable the individual to receive the necessary guidance relevant for their specific needs and help to improve their quality of life
CPD reflective questions
- Reflect on possible reasons why people with an irregularly shaped stoma seemed less likely to experience leakage onto their clothes
- Why is it important for stoma patients to check the fit of their stoma appliance over time? How would they go about this?
- What advice and support have you been able to offer patients worried about or experiencing leakage?