A New Decision Tool to Objectively Select the Most Appropriate Ostomy System – A Survey Among Ostomy Nurse Specialists

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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Wound Management & Prevention or HMP Global, their employees, and affiliates.

Ostomy is a surgical intervention that creates an opening in a hollow organ in order to facilitate excretion of waste products (feces and urine) from the body.¹ According to the anatomical site of intervention, ostomies are mainly classified as colostomy, ileostomy, and urostomy, referring to a surgical opening from the colon, an isolated segment of the ileum, or the bladder, respectively.^2,3 In these cases, the normal function of the organ is temporarily or permanently disrupted so as to drain waste, which flows through the abdominal wall and the stoma into an appliance that must be emptied periodically.^3,4 Recent estimates report that 1.3 million patients have an ostomy worldwide,⁵ and that in Italy, this intervention has been delivered to more than 80 000 individuals so far, equally distributed between males and females,⁶ with an incidence of 0.13%.⁷

Temporary or permanent ostomies often represent a life-saving intervention as part of the surgical management of a wide series of either benign or malignant medical conditions,^8,9 but are associated with a significant reduction in the quality of life (QoL) of patients due to complex physical, psychological, and social implications.^2,10 Moreover, ostomy surgery is associated with minor and major complications that increase the negative impact on individuals’ physical and psychological health.^9,11

Complications vary in response to specific patient- and surgery-related factors.^9,12-15 Peristomal skin complications likely represent the most common complication category, showing an incidence of up to 76% of cases.^16–22 These complications are a consequence of leaking events,^17,23,24 most frequently due to the occurrence of a parastomal hernia, retraction of the ostomy, mucocutaneous detachment, or changes in the abdominal profile.^25-27 Besides the detrimental effects on the skin, leaking may lead patients to face embarrassing situations that affect their social relationships.²⁸ In this perspective, the adequate selection of the pouching system is fundamental to reduce the risk of skin complications and favor the psychological well-being of ostomy patients.

As a rule, a good ostomy bag pouching system should be perfectly sealed to prevent the contact between the abdominal skin and the effluents, as well as to prevent maceration of the membrane in contact with the skin.²⁸

Choosing the most adequate ostomy product(s) is often difficult and should rely on the analysis of both ostomy features (e.g., type of stoma, stoma construction, issues with concealment) and the characteristics of the patient, including the body shape, the daily activity, and personal preferences.²⁹ To guide professionals in the selection of ostomy product(s), Coloplast S.p.A., in association with Ostomy Nurse Specialists (ONS) from different countries across the world, developed the Peristomal Body Profile Assessment Tool.^28,30 This tool has been demonstrated to be an effective starting point for ONS to objectively assess the peristomal body profile of patients.²⁵ However, it is only available online and is not accessible to all health care professionals. Therefore, the choice of the ostomy system still largely depends on the subjective evaluation of the ONS or the stoma-therapist. In this process, the personal experience and expertise of the practitioner still play a key role,³¹ thus reducing the possibility of standardizing the system selection. Additionally, short-term changes in the abdominal profile may interfere with the adaptation of the pouching system to the body shape few days after intervention, thus leading to skin complications that require changing the technical characteristics of the pouching system. From this perspective, an additional decision tool was recently developed to support professionals in choosing the most appropriate ostomy system depending on patients’ characteristics defined according to the Body Profile Terminology³²

The present article reports descriptive results of a survey aiming to evaluate the functionality of this new tool in identifying the most appropriate ostomy system depending on the characteristics of the patients. To this purpose, the overall experience of ONS or stoma-therapists was considered in multiple cases in which the tool was applied. Functionality of the tool was evaluated by analyzing short-term confirmation of the prescription of the ostomy products according to indications provided by the subject tool.

The tool “Mi Regolo” (Coloplast S.p.A.) was developed by the Coloplast Ostomy Forums (COF – a group consisting of 15 stoma care nurses from 11 different countries with many years of experience and high levels of expertise within stoma care) between September 2021 and December 2021, and it is now used in Italy by stoma-therapist nurses and surgeons. It consists of a circular card composed of 2 disks (Figure 1). The external disk includes the 3 abdominal profiles usually described in the literature (inward, outward, or regular), while the inner disk reports information on the different situations that a practitioner may face when evaluating an ostomy (budded ostomy, flush ostomy, or retracted ostomy), including the possibility of a saggy abdomen. The inner disk can be rotated to align the abdominal profile to the ostomy type. The most suitable ostomy system will be indicated by the triangular empty space of the inner disk in accordance with the patient’s characteristics. The health care professionals were adequately trained to the application of the tool; training consisted of frontal lessons covering scientific background aspects as well as a full description of both the project and the tool.

The survey was conducted from April 2022 to March 2023 and aimed to investigate the functionality of the tool by focusing specifically on new ostomy surgeries including colostomy, ileostomy, and urostomy. For the purpose of the analysis, experienced nurses or ONS included in the COF and being part of the Nurse Expert Panel (NEP – a large group of expert nurses selected according to their clinical expertise in ostomy care) were asked to report about their experience in using the new decision tool when they had to select the most appropriate ostomy bag pouching system. Included practitioners were asked to fill in a questionnaire consisting of 2 sections (Figure 2). Each health care professional participating in the survey completed the first part of the questionnaire at the hospital ward immediately after the intervention. This part of the survey allowed investigators to retrieve information about the collective experience that practitioners had regarding the frequency of ostomy intervention type, the abdominal profile (inward, regular, outward), and the ostomy characteristic (budded, flush, retracted) observed, as well as about the system SenSura®/SenSura® Mio (Coloplast S.p.A.) mostly prescribed – one-piece, two-piece “Click,” or two-piece “Flex.” For each system category, practitioners were asked to report on the plate type mostly applied and to indicate plate characteristics for each plate type. Each health care professional then completed the second part of the questionnaire at the same hospital and collected information about changes in the abdominal profile and ostomy characteristics usually observed in the short-term (about 30 days from the first prescription). A specific question in this second part of the questionnaire was if the tool usually allowed the health care professional to confirm the ostomy bag pouching system depending on the abdominal profile and ostomy characteristics. The possible answers to this last question were “Yes” and “No.” The reason for system change and information about the characteristics of the new system prescribed were also reported.

Results collected through this questionnaire-based survey reported the overall experience of the professionals included, with no patient-specific information. Therefore, data were compliant with ethical standards.

Data analysis. Data were analyzed by means of descriptive statistics, which consisted of the calculation of absolute and relative frequencies of the available categories. Descriptive analyses aimed to synthesize the overall epidemiological data, including information on how frequently ONS reported about colostomy, ileostomy, or urostomy. Information about the abdominal profile, the ostomy characteristics, and the type of selected system were also analyzed. For each system category, frequencies of the main plate type were calculated along with the analysis of plate features. Characteristics of both the main abdominal profile and the main ostomy reported immediately after intervention were compared to information reported after about 1 month. Functionality of the tool was assessed by analyzing how frequently practitioners reported that the choice of the ostomy products was confirmed 1 month from prescription. Functionality of the tool was tested statistically by applying a binomial test. Functionality was assessed also after stratifying data according to the ostomy intervention type by applying a chi-square test. Results were considered significant with α = .05. Data analysis was performed using Microsoft Excel and R.

A total of 959 questionnaires were analyzed. Overall, answers from practitioners indicated that subjects undergoing ostomy surgery were mostly males (569/959; 59%) and that ostomies were performed on subjects that were usually around 65 years old (range, 1-97). Independently of sex, the most represented age class was in the range 71 to 80 years old.

Ileostomy was the most frequent ostomy surgery (414/959 cases; 43.17%), followed by colostomy (348/959 cases; 36.29%), and urostomy (197/959 cases; 20.54%). Ileostomy and colostomy were equally reported independently of sex (230/414; 55.56% and 196/348, 56.32%, respectively), while urostomy was mainly reported in relation to the overall treatment of males (143/197; 73%) (Figure 3).

Abdominal profile and ostomy characteristics were mostly consistent in the short-term after surgery because variations were observed within the maximum limit of 2.4% of cases (Figure 4a and 4b). The abdominal profile was mostly regular both immediately after intervention (606/959; 63.19% of cases) and after about 1 month (619/959; 64.55%). Ostomy was mostly budded both immediately after intervention (459/959; 47.86% of cases) and after about 1 month (432/959; 45.05%). According to the abdominal profile and ostomy characteristics reported by professionals, the survey indicated that the one-piece pouching system was prescribed most often (515 cases; 53.7%), followed by the two-piece system “Click” (258 cases; 26.9%), and the two-piece system “Flex” (186 cases; 19.4%). When the one-piece system was prescribed, the plate type applied was mostly convex (310/515 cases; 60.2%) and the convex plate was mostly soft (217/310 cases; 70%).

Overall, nurses and stoma-therapists supported a high functionality of the tool, because the pouching system chosen immediately after intervention was confirmed in 95% of cases (911/959; P < .001) (95% confidence interval: 93%-96%) in the short-term (Figure 5a). Revision after about 1 month varied slightly according to the type of intervention (χ² = 4.65; d.f. = 2; P = .1), with the highest frequency related to ileostomy (27/959; 2.82% of the total cases), followed by colostomy (16/959; 1.67% of the total cases) and urostomy (5/959; 0.52% of the total cases). Relative frequencies calculated for each intervention category suggested that revision was more probable in case of ileostomy (27/414; 6.52%), followed by colostomy (16/348; 4.6%) and urostomy (5/197; 2.54%) (Figure 5b).

A new tool was recently developed to support professionals in choosing the most appropriate ostomy products depending on patients’ characteristics to improve the standardization of the decision process and reduce ostomy postsurgical complications. It demonstrated a very high functionality, since the choice of the ostomy products according to the indications of the tool was confirmed at follow-up in almost the entire set of questionnaires analyzed. Ostomy product selection can be very challenging for nurses and stoma-therapists, as the body profile, characteristics of the stoma, and conformation of the peristomal skin largely differ among patients and may widely change after surgical intervention.^{23,25,26,28,33,34} Creases and folds in the ostomy area can often occur soon after surgery due to altered metabolism and physical activity.³⁴ Such modifications increase the risk that the patient faces output under the baseplate, thus requiring re-evaluation and revision of the ostomy system applied.^25,35 The tool described in the present article may favor appropriate selection of the ostomy products even in the short-term by preventing and reducing postsurgical complications due to effluent leakage from the stoma,^26,30 which represents the most frequent complication after ostomy intervention and the main driver of a low QoL for ostomy patients.^23,35-37

Previous studies suggested that the risk of leakage varies according to the body profile because a higher number of leakages were observed in individuals with an inward peristomal body than in patients with a regular profile.^25,35 The present study suggested that variations in the abdominal profile and the ostomy characteristics may be rather limited in the 30 days after prescription, and such consistency may have also favored the effectiveness of the tool. The abdominal profile was reported to be mostly regular and the ostomy was mostly budded, while an inward body profile was observed to vary from 18.35% at the prescription to 19.08% after 1 month, in line with previous reports.^25,35 Despite these slight variations, data from the present study may provide further evidence that an inward body profile could imply higher risk of revision, given the increased frequency of questionnaires reporting inward profiles at follow-up. The results may also suggest that probability of system revision may vary according to surgical intervention, as the tool may show a slightly lower functionality in cases of ileostomy. It should be noted that, in the present study, ileostomy overall represented the most frequent intervention, in contrast with other reports describing mostly colostomy.^23,25,39 A higher revision rate in case of ileostomy might relate to a low representativeness of colostomy in the present experience.

The high functionality of the subject tool may also be explained by the characteristics of the ostomy products applied. The one-piece system was confirmed as the preferred choice in more than half (53.7%) of the questionnaires, in line with previous reports showing that one-piece system application varied between 53% and 70.1% of cases.²⁵ The present study suggested that when the one-piece system solution was applied, the plate type was mostly convex (60.19%). This preference can depend on the higher effectiveness shown by convex base plates in preventing leakage; convex base plates can flatten creases and folds around the ostomy, thus facilitating ostomy protrusion above the skin and the efficient drainage of the effluent into the pouch without contact with skin.^26,39-44 When using a convex base plate, main limitations refer to the lack of flexibility (which makes the pouch uncomfortable to wear) and to a deep convexity (which may cause friction and formation of granulomas).^43,45 These drawbacks may explain the preference observed for the soft convex base plate in the present study. The one-piece system equipped with a convex and flexible base plate may already offer high versatility in the prescription of ostomy products.

To the best of the authors’ knowledge, no other similar tool has ever been presented. In addition to the technological improvements of ostomy systems, the results from the questionnaire-based survey described in this article introduce the subject tool as a relevant decision-supporting system, helping nurses and stoma-therapists in the prescription of the ostomy products that best fit to the characteristics of each patient. Therefore, the tool can help to prevent and reduce postsurgical complications due to effluent leakage and improve patients’ confidence and rehabilitation.

The main limitation of this study is its descriptive nature, as it consisted of questionnaires aimed at collecting the overall experience of nurses and ONS in using the tool. Therefore, these preliminary data should be further supported by dedicated clinical studies, including adequate estimation of analytical power and possibly investigating if the functionality of the subject tool may vary depending on the experience of professionals. 

Ostomy surgeries represent life-saving interventions as part of the surgical management of a wide series of medical conditions. Nonetheless, ostomy patients often suffer from complex physical, psychological, and social disturbances that are mostly related to effluent leakage from the stoma. Adequate selection of the ostomy product(s) can reduce and prevent outputs under the base plate and lessen the risk of skin complications and consequent impairment of the QoL of the patients. However, selecting the most appropriate ostomy product(s) is often difficult and subject to the experience and expertise of nurses and ostomy nurse specialists. The tool described in the present article can be highly effective in supporting professionals to more objectively select the most adequate ostomy product(s) according to the characteristics of the patients. After about 1 month from device prescription assisted by the subject tool, 95% of cases reported that the system was usually confirmed, showing a high functionality even in the short term when changes in the body profile and ostomy characteristics are more likely to occur. 

Acknowledgments: The authors acknowledge the Coloplast Ostomy Forum Group for its role in the design of the survey and the development of the tool.

Authors: Vincenzo Pedace, MD¹; Marco Della Valle, RN¹; Coloplast Ostomy Forum; and Nurse Expert Panel

Affiliations: ¹Coloplast Italia, Bologna, Italy

Disclosures: Vincenzo Pedace and Marco Della Valle are employees of Coloplast Italia (Bologna) and had a coordinating role in the questionnaire-based survey. The ostomy nurses involved in the survey have no conflict of interest to declare. The Italian Coloplast Ostomy Forum Group had a role in the experimental design and the development of the tool by providing information about the scientific background and the clinical scenario in which the tool is applied.

Correspondence: Vincenzo Pedace, MD, Medical Marketing Manager Chronic Care, Coloplast S.p.A., Via dei Trattati Comunitari Europei, 1957-2007, 9/F, 40127 Bologna (BO); itvp@coloplast.com

1.         Hyland J. The basics of ostomies. Gastroenterol Nurs. 2002;25(6):241-244; quiz 244-245. doi:10.1097/00001610-200211000-00003

2.         Ambe PC, Kurz NR, Nitschke C, Odeh SF, Möslein G, Zirngibl H. Intestinal ostomy: classification, indications, ostomy care and complication management. Deutsches Ärzteblatt International. 2018;115(11):182.

3.         Gardiner A. Addressing common stoma complications. Nursing and Residential Care. 2013;15(3):128-133. doi:10.12968/nrec.2013.15.3.128

4.         Zucal G. Evidence Profile Q1: Supporting adults who anticipate or live with an ostomy. Published online 2020.

5.         Li J, Zhang Q, Wu X, Pang D. The quality and clinical applicability of recommendations in ostomy guidelines: a systematic review. Risk Manag Healthc Policy. 2022;15:1517-1529. doi:10.2147/RMHP.S378684

6.         FAIS. Published online 2018. Federazione Associazioni Incontinenti e Stomizzati. FAIS Social Report 2018. Accessed March 24, 2023. http://www.fais.info/wp-content/uploads/2019/03/Report-numero-verde-2018-1.pdf

7.         FAIS.Federazione Associazioni Incontinenti e Stomizzati. FAIS Press Release. Published online 2022. Accessed March 24, 2023. https://issuu.com/faisonlus8/docs/comunicato_stampa_fais_giornata_3_12

8.         Meira IF de A, Silva FR da, Sousa AR de, Carvalho ES de S, Rosa D de OS, Pereira Á. Repercussions of intestinal ostomy on male sexuality: an integrative review. Revista Brasileira de Enfermagem. 2020;73.

9.         Murken DR, Bleier JIS. Ostomy-related complications. Clin Colon Rectal Surg. 2019;32(3):176-182. doi:10.1055/s-0038-1676995

10.       Della Valle M. The Italian Wellness Survey of more than 1000 ostomy patients: trends in patient adjustment after stoma placement. Wound Manag Prev. 2022;68(10):12-19.

11.       Kwiatt M, Kawata M. Avoidance and management of stomal complications. Clin Colon Rectal Surg. 2013;26(02):112-121.

12.       Babakhanlou R, Larkin K, Hita AG, Stroh J, Yeung SC. Stoma-related complications and emergencies. Int J Emerg Med. 2022;15(1):1-9.

13.       Dellafiore F, Caruso R, Bonavina L, et al. Risk factors and pooled incidence of intestinal stoma complications: systematic review and meta-analysis. Curr Med Res Opin. 2022;38(7):1103-1113.

14.       Zelga P, Kluska P, Zelga M, Piasecka-Zelga J, Dziki A. Patient-related factors associated with stoma and peristomal complications following fecal ostomy surgery: a scoping review. J Wound Ostomy Continence Nurs. 2021;48(5):415-430.

15.       Caricato M, Ausania F, Ripetti V, Bartolozzi F, Campoli G, Coppola R. Retrospective analysis of long-term defunctioning stoma complications after colorectal surgery. Colorectal Dis. 2007;9(6):559-561. doi:https://doi.org/10.1111/j.1463-1318.2006.01187.x

16.       Claessens I, Probert R, Tielemans C, et al. The Ostomy Life Study: the everyday challenges faced by people living with a stoma in a snapshot. Gastrointestinal Nursing. 2015;13(5):18-25.

17.       Gray M, Colwell JC, Doughty D, et al. Peristomal moisture–associated skin damage in adults with fecal ostomies: a comprehensive review and consensus. J Wound Ostomy Continence Nurs. 2013;40(4):389-399.

18.       Lindholm E, Persson E, Carlsson E, Hallén AM, Fingren J, Berndtsson I. Ostomy-related complications after emergent abdominal surgery: a 2-year follow-up study. J Wound Ostomy Continence Nurs. 2013;40(6):603-610.

19.       Salvadalena GD. The incidence of stoma and peristomal complications during the first 3 months after ostomy creation. J Wound Ostomy Continence Nurs. 2013;40(4):400-406.

20.       Salvadalena G. Incidence of complications of the stoma and peristomal skin among individuals with colostomy, ileostomy, and urostomy: a systematic review. J Wound Ostomy Continence Nurs. 2008;35(6):596-607.

21.       Welser M, Riedlinger I, Prause U. A comparative study of two-piece ostomy appliances. Br J Nurs. 2009;18(9):530-538.

22.       Brown H, Randle J. Living with a stoma: a review of the literature. J Clin Nurs. 2005;14(1):74-81.

23.       Goldstine J, van Hees R, van de Vorst D, Skountrianos G, Nichols T. Factors influencing health-related quality of life of those in the Netherlands living with an ostomy. Br J Nurs. 2019;28(22):S10-S17. doi:10.12968/bjon.2019.28.22.S10

24.       Martins L, Samai O, Fernández A, Urquhart M, Hansen AS. Maintaining healthy skin around an ostomy: peristomal skin disorders and self-assessment. Gastrointestinal Nursing. 2011;9(Sup2):9-13. doi:10.12968/gasn.2011.9.Sup2.9

25.       Vendelbo G, Carlsson E, Tøndel LT, et al. Using peristomal body profile assessment to improve leakage-related quality of life for individuals with an ostomy. Br J Nurs. 2023;32(4):173-181. doi:10.12968/bjon.2023.32.4.173

26.       Rat P, Robert N, Fernandes I, Edmond D, Mauvais F. Evaluation of a one-piece soft convex ostomy appliance: a prospective, multicentre, open-label pilot study. Br J Nurs. 2018;27(16):S20-S28. doi:10.12968/bjon.2018.27.16.S20

27.       Herlufsen P, Olsen AG, Carlsen B, et al. Study of peristomal skin disorders in patients with permanent stomas. Br J Nurs. 2006;15(16):854-862. doi:10.12968/bjon.2006.15.16.21848

28.       Colwell JC, Bain KA, Hansen AS, Droste W, Vendelbo G, James-Reid S. International consensus results: development of practice guidelines for assessment of peristomal body and stoma profiles, patient engagement, and patient follow-up. J Wound Ostomy Continence Nurs. 2019;46(6):497-504.

29.       Foà C, Bisi E, Calcagni A, et al. Infectious risk in ostomy patient: the role of nursing competence. Acta Bio Medica: Atenei Parmensis. 2019;90(Suppl 11):53.

30.       James-Reid S, Bain K, Hansen AS, Vendelbo G, Droste W, Colwell J. Creating consensus-based practice guidelines with 2000 nurses. Br J Nurs. 2019;28(22):S18-S25.

31.       O’Flynn SK. Care of the stoma: complications and treatments. Br J Community Nurs. 2018;23(8):382-387.

32.       Ostomy Life Study 2015/16 Review. https://www.coloplast.com/Documents/Stoma/CP_MM_OstomyLifeStudy_2016.pdf

33.       Zhang Y, Xian H, Yang Y, Zhang X, Wang X. Relationship between psychosocial adaptation and health‐related quality of life of patients with stoma: a descriptive, cross‐sectional study. J Clin Nurs. 2019;28. doi:10.1111/jocn.14876

34.       Rolstad BS, Erwin-Toth PL. Peristomal skin complications: prevention and management. Ostomy Wound Manage. 2004;50(9):68-77.

35.       Martins L, Tavernelli K, Sansom W, et al. Strategies to reduce treatment costs of peristomal skin complications. Br J Nurs. 2012;21(22):1312-1315. doi:10.12968/bjon.2012.21.22.1312

36.       Jeppesen PB, Vestergaard M, Boisen EB, Ajslev TA. Impact of stoma leakage in everyday life: data from the Ostomy Life Study 2019. Br J Nurs. 2022;31(6):S48-S58. doi:10.12968/bjon.2022.31.6.S48

37.       Osborne W, White M, Aibibula M, Boisen EB, Ainsworth R, Vestergaard M. Prevalence of leakage and its negative impact on quality of life in people living with a stoma in the UK. Br J Nurs. 2022;31(16):S24-S38. doi:10.12968/bjon.2022.31.16.S24

38.       Voegeli D, Karlsmark T, Eddes EH, et al. Factors influencing the incidence of peristomal skin complications: evidence from a multinational survey on living with a stoma. Gastrointestinal Nursing. 2020;18(Sup4):S31-S38. doi:10.12968/gasn.2020.18.Sup4.S31

39.       Fellows J, Voegeli D, Håkan-Bloch J, Herschend NO, Størling Z. Multinational survey on living with an ostomy: prevalence and impact of peristomal skin complications. Br J Nurs. 2021;30(16):S22-S30. doi:10.12968/bjon.2021.30.16.S22

40.       Colwell JC, Stoia Davis J, Emodi K, et al. Use of a convex pouching system in the postoperative period: a national consensus. J Wound Ostomy Continence Nurs. 2022;49(3):240-246. doi:10.1097/WON.0000000000000874

41.       Perrin A, White M, Burch J. Convexity in stoma care: developing a new ASCN UK guideline on the appropriate use of convex products. Br J Nurs. 2021;30(16):S12-S20. doi:10.12968/bjon.2021.30.16.S12

42.       Carlsson E, Fingren J, Hallén AM, Petersén C, Lindholm E. The prevalence of ostomy-related complications 1 year after ostomy surgery: a prospective, descriptive, clinical study. Ostomy Wound Manage. 2016;62(10):34-48.

43.       Kruse TM, Størling ZM. Considering the benefits of a new stoma appliance: a clinical trial. Br J Nurs. 2015;24(22):S12, S14-18. doi:10.12968/bjon.2015.24.Sup22.S12

44.       Hoeflok J, Kittscha J, Purnell P. Use of convexity in pouching: a comprehensive review. J Wound Ostomy Continence Nurs. 2013;40(5):506-512. doi:10.1097/WON.0b013e3182a219b7

45.       Cronin E. A guide to the appropriate use of convex stoma care products. Gastrointestinal Nursing. 2008;6(2):12-16. doi:10.12968/gasn.2008.6.2.28803