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CADTH Health Technology Review
Authors; Robyn Haas, Jennie Horton, and Angie Hamson.
Parastomal hernia is a common complication that occurs after a person undergoes surgery to create an ostomy, which is a surgically created opening in the abdominal wall that allows bodily waste to pass into an external pouch or bag.1 This type of hernia occurs when part of the intestine protrudes through the abdominal muscles, causing a bulge around the ostomy site.2 The reported incidence of parastomal hernia following ostomy surgery varies. Some literature suggests that incidence may range from 0% to 50%, while others indicate that it may be as high as 78%.1,2 Most people who develop a parastomal hernia will do so within the first 2 years following surgery, though they can occur at any time. People with a parastomal hernia may experience pouch leakages, leading to skin damage and difficulties maintaining a seal for the ostomy pouching system.2 Additionally, they might experience bowel obstructions and chronic pain in the abdomen, back, or hips. In rare instances, people can experience bowel strangulation and ischemia.2 In addition to these complications, living with a parastomal hernia can negatively impact a person’s quality of life due to stress related to body image, fatigue, and the physical burden of the hernia.3
A hernia support garment, sometimes called a hernia belt, is specifically designed to compress and stabilize the stoma site lightly, which is the visible part of the ostomy.2 Patients commonly wear these garments following ostomy surgery to help prevent the occurrence of a parastomal hernia, or they may wear them after developing a hernia to manage symptoms and reduce complications.2 Hernia support garments are available in a range of sizes and widths and provide various levels of support.4 Some garments have a hole cut-out that goes around the ostomy pouching system, while others do not.4 These garments can also vary in cost. The type of garment a person might wear can depend on their type of stoma, function, type of pouch, size and shape of stoma, and personal characteristics and comorbidities.4 Ideally, these garments should be comfortable, provide the necessary level of support, fit appropriately, and suit the individual’s needs.4
Approximately 750,000 people are living with an ostomy in North America.1 In Canada alone, surgeons perform about 13,000 new ostomies per year, and each of these individuals are at risk for developing a parastomal hernia.5 Those living with an ostomy may avoid participating in certain types of physical activity due to fear of developing a parastomal hernia, which can, in turn, affect their overall well-being.6 People who develop a parastomal hernia may have the option to undergo surgical repair, but this option is expensive, and the recurrence rate of hernia is around 50%.2,7 Surgical repair can also be associated with an increased risk of morbidity and mortality.8 As such, strategies for prevention and management of parastomal hernia, such as hernia support garments, may be a better option. By conducting this review, we can explore the available evidence to determine whether hernia support garment are effective options for parastomal hernias.
The purpose of this report is to summarize and critically appraise the evidence identified from medical databases and grey literature searching about the clinical and cost-effectiveness of hernia support garments for parastomal hernia following ostomy procedure. We also aimed to identify evidence-based guidelines about the use of hernia support garments.
An information specialist conducted a literature search on key resources including MEDLINE, the Cochrane Database of Systematic Reviews, the International Health Technology Assessment Database, the websites of Canadian and major international health technology agencies, as well as a focused internet search. The search approach was customized to retrieve a limited set of results, balancing comprehensiveness with relevancy. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. Search concepts were developed based on the elements of the research questions and selection criteria. The main search concepts were parastomal hernia and support garments. No filters were applied to limit the search by study type. An additional search was run for parastomal hernia with CADTH-developed search filters applied to limit retrieval to guidelines. The search was completed on November 1, 2023 and limited to English-language documents published since January 1, 2013.
One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.
Selection Criteria.
We excluded articles if they did not meet the selection criteria in Table 1, they were duplicate publications, or were published before 2013. We also excluded guidelines with unclear methodology.
The included publications were critically appraised by 1 reviewer using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument.9 Summary scores were not calculated for the included studies; instead, each publication's strengths and limitations were described narratively.
Patient engagement is an important component of CADTH’s work. CADTH has a Patient Engagement Framework to guide our engagement processes. Patients contribute their thoughts and perspectives to highlight their priorities and contextualize what is found in the literature. For this report, CADTH engaged a patient contributor with the lived experience of wearing a hernia support garment.
A request to engage was disseminated through a wound, ostomy, and continence nurse. A patient with an ostomy and parastomal hernia who wears a hernia belt daily was identified to participate. The patient contributor was invited to participate in a Zoom video call with a Patient Engagement Officer and Research Officer. They signed a consent form and participated in a 1-hour dialogue about his experiences, perspectives, and priorities. A summary of the key points was drafted, approved by the patient, and shared with the Research Officer authoring the report. An honorarium was offered to the patient as a gesture of thanks for his time and expertise, and they elected to remain anonymous in the report’s acknowledgements.
An individual with lived experience of an ostomy and a parastomal hernia, who regularly wears a hernia belt shared his experiences with CADTH staff. We used the perspectives gained through this process to provide insight and context to this report.
Patient involvement was guided by the Guidance for Reporting Involvement of Patients and the Public (version 2) Short Form reporting checklist,10 which is outlined in Appendix 5.
A total of 496 citations were identified in the literature search. Following screening of titles and abstracts, 473 citations were excluded and 23 potentially relevant reports from the electronic search were retrieved for full-text review. Three potentially relevant publications were retrieved from the grey literature search for full-text review. Of these potentially relevant articles, 23 publications were excluded for various reasons and 3 publications met the inclusion criteria and were included in this report. All 3 of these publications were evidence-based guidelines. Appendix 1 presents the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)8 flow chart of the study selection. Additional references of potential interest are provided in Appendix 6.
This report includes 3 evidence-based guidelines with recommendations that were developed from systematic searches for relevant evidence.1,4,11 The recommendations provide guidance related to parastomal hernia risk assessment and postoperative education regarding using hernia support garments in individuals who have had or anticipate having ostomy surgery.
Appendix 2 presents additional details regarding the characteristics of the included guidelines.
The evidence-based guidelines in this report were developed by the Nurses Specialized in Wound, Ostomy, and Continence Canada (NSWOCC),4 the Registered Nurses’ Association of Ontario (RNAO),1 and the Association of Coloproctology of Great Britain and Ireland (ACPGBI) Parastomal Hernia Group.11 The guidelines were published in 2023, 2019, and 2018.1,4,11
All of the guidelines systematically searched the literature using multiple databases.1,4,11 The NSWOCC and ACPGBI guidelines also included a handsearch of the literature.4,11 The RNAO and ACPGBI guidelines used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to rate the certainty of evidence used to inform recommendations as high, moderate, low, or very low.1,11 The RNAO guideline also used the Confidence in the Evidence from Reviews of Qualitative (CERQual) research to help assess qualitative studies.1 The RNAO guideline classified the strength of recommendations as either solid or conditional. The ACPGBI guideline classified the strength of recommendations as either strong or weak.1 The authors of the NSWOCC guideline assigned a level of evidence to their recommendations based on a 7-level scale.4 The levels were: Ia (highest), Ib, IIa, IIb, II, IV, V (lowest). Each level corresponds to the study design of the source of the evidence.4 Refer to Appendix 2 for a full description of these levels of evidence.
The authors of both the RNAO and NSWOCC guidelines were from Canada and the guidance was developed for use in Canada.1,4 The authors of the ACPGBI guideline were from the UK and were intended for use by practitioners in Great Britain and Ireland.11
The target population for all the guidelines were people living with an ostomy or those who anticipate living with an ostomy (i.e., people awaiting ostomy surgery).1,4,11 The RNAO guideline was specifically targeted toward adults 18 years and older.1 The NSWOCC and ACPGBI guidelines did not report whether their recommendations applied to specific age groups. The intended users for the RNAO and NSWOCC guidelines included nurses specialized in wound, ostomy, and continence care as well as others on the interprofessional team (e.g., physicians, allied health professionals) who support people who currently live or who will live with an ostomy.1,4 The ACPGBI guideline reported that their intended users were ACPBGI members.11
All the guidelines examined various interventions for assessing, preventing, and managing parastomal hernias, including hernia support garments.1,4,11 These guidelines specifically considered the role of nurses specialized in wound, ostomy, and continence care, sometimes referred to as stoma care nurses, in providing perioperative or postoperative assessment, counselling, and educating individuals about garments that would best fit their needs and lifestyle.1,4,11 The ACPGBI guideline also includes a recommendation about the role of nurses specialized in wound, ostomy, and continence care for non-operative care options for parastomal hernias more generally.11
All 3 guidelines considered the risk of developing a parastomal hernia and the severity of symptoms associated with the hernia when formulating recommendations relevant to this report.1,4,11 The guidelines also considered outcomes not related to the use of hernia support garments. However, these were not relevant to this report.
This section presents a narrative summary of the strengths and limitations of the included guidelines. Additional details are provided in Appendix 3.
All guidelines stated their scope and objectives, described the range of health questions covered and their target users, and indicated the populations to whom the guidelines were meant to apply.1,4,11 They also included individuals from relevant professional groups during the guideline development process.1,4,11 These professional groups included nurses specialized in the field, colorectal surgeons, and allied health professionals (e.g., physiotherapists).1,4,11 While the NSWOCC guideline noted that it underwent review by individuals with subject matter expertise, it was not clear whether any of these individuals were patients or members of the public.4 The RNAO guideline indicated that they sought out and incorporated the views and preferences of individuals with lived experience as part of the guideline development process.1 The guideline developers engaged these individuals in virtual focus groups intended to understand their needs.1 The ACPGBI guideline did not report whether they sought out views and preferences of the target population.11
All guidelines used systematic methods to search for evidence for consideration when developing recommendations.1,4,11 The RNAO guideline clearly presented their criteria for selecting evidence and described the strengths and limitations of this evidence.1 The NSWOCC and ACPGBI guidelines only partially included this information.4,11 They provided the overall parameters for selecting evidence (e.g., time frame, language restrictions) and mentioned that they used inclusion and exclusion criteria, but they did not report specific details of these criteria.1,4,11 These 2 guidelines also noted some limitations around the quality of evidence they included but provided minimal details.1,4,11 This lack of detail in the NSWOCC and ACPGBI guidelines may, in turn, decrease the reproducibility in the selection of studies that informed the recommendations.1,4,11 All 3 guidelines considered the health benefits, side effects, and risks of their recommendations and clearly presented the link between the recommendations and supporting evidence.1,4,11 The NSWOCC and RNAO guidelines were both externally reviewed by experts before publication.1,4 A total of 28 peer reviewers with expertise on parastomal hernias reviewed the NSWOCC guideline.4 Nurses and individuals with lived experience reviewed the RNAO guideline.1 The ACPGBI guideline did not report whether it had been externally reviewed by experts before its publication.11 Only the RNAO guideline provided a procedure for updating their guideline.1
The key recommendations in all guidelines were easily identifiable and included different options for assessment, prevention, and management for parastomal hernias.1,4,11 While most recommendations across all guidelines were specific and unambiguous, the ACPGBI guideline included some recommendations that were broad in scope as they lacked details around the population(s) for whom they were intended and to whom they applied.11 This may be a result of the lack of high-quality evidence that the authors noted.11
The RNAO guideline considered the potential resource implications of their recommendations by implementing a previously created toolkit12 designed to facilitate the implementation of their guidelines into clinical practice based on the local context (e.g., the availability of resources).1 The NSWOCC guideline gave some consideration to the resource implications of their recommendations by acknowledging costs to the health care system and potential costs and accessibility for interventions such as hernia support garments.4 The ACPBGI guideline did not report on the potential resource implications of their recommendations.11 The RNAO guideline was the only 1 that presented monitoring criteria, described facilitators and barriers to its application, and provided tools to implement the recommendations.1
All guidelines declared potential conflicts of interest of guideline development group members. The RNAO and NSWOCC guidelines reported on their sources of funding. The RNAO guideline explicitly stated that the authors had editorial independence from the funding organizations. One author from the NSWOCC guideline declared a relevant conflict of interest. It is unclear if the funding body influenced the recommendations made in the guideline. The ACPBGI guideline declared that the authors had no conflicts of interest but did not report a source of funding.
All the guidelines used rigorous methodology and were comprehensively and clearly reported.1,4,11
Appendix 4 presents the detailed recommendations and supporting evidence that are relevant to this report.
No relevant evidence was identified regarding the clinical effectiveness of hernia support garments for patients at risk of parastomal hernia development postostomy; therefore, no summary can be provided.
No relevant evidence was identified regarding the cost-effectiveness of hernia support garments for patients at risk of parastomal hernia development postostomy; therefore, no summary can be provided.
The NSWOCC guideline recommends that a nurse specialized in wound, ostomy, and continence care or other health care provider should assess individuals who live with an ostomy to determine the type and level of support garment needed for the prevention or management of a parastomal hernia.4 The assessment should consider the person’s lifestyle, activities of daily living, and personal preferences.4 This recommendation was based on the 3 lowest levels of evidence on the 7-level scale, including qualitative studies, non-experimental observational studies, and expert opinion, committee report, or clinical experiences.4
The RNAO guideline recommends that health professionals provide postoperative education about lightweight support garments to individuals who have or will have an ostomy (conditional recommendation), based on a very low certainty evidence.1 Similarly, the ACPGBI recommends that stoma care nurses provide counselling and advice about support garments for people with a stoma (weak recommendation) based on low-quality evidence.11 They also recommend that individuals with a stoma have access to stoma care nurses to advise them on non-operative management for parastomal hernias more generally (strong recommendation), based on low-quality evidence.11
There were few guidelines that met the inclusion criteria for this report, and those that did meet the criteria contained a small number of applicable recommendations. The scope of these recommendations was limited to the role of nurses specialized in wound, ostomy, and continence care or stoma care nurses in assessing and educating patients about hernia support garments. One recommendation indicated that the patient’s lifestyle, activities of daily living, and personal preference are important considerations when determining the type and level of support garment to recommend. However, the recommendations did not include more granular details such as the number of hours a day 1 should wear a support garment, how often 1 might need to replace a garment, or when to provide a more supportive versus a less supportive garment. Additional gaps in the identified literature include information about the types of patient populations who should use a support garment and the duration for which patients should use a support garment after surgery. Finally, all the recommendations were based on low- or very low-quality evidence. This, in turn, can limit their applicability.
Through the search of medical databases and grey literature, we did not identify any eligible studies evaluating the clinical or cost-effectiveness of hernia support garments for people who have or who are at risk of developing parastomal hernia. As a result, we can neither comment on the comparative benefits or harms of hernia support garments, nor can we comment on the quality of evidence in this area. It is possible that relevant literature about hernia support garments for preventing and managing parastomal hernia exists but was published more than 10 years ago. However, it does not appear that there is a large body of literature about hernia support garments for these outcomes.
Based on the literature search conducted for this review, we did not identify any evidence about the clinical or cost-effectiveness of hernia support garments for patients at risk of or who have a parastomal hernia. We included 3 evidence-based guidelines in this report, all rigorous, comprehensive, and clear in their methodology and reporting.1,4,11 The relevant recommendations were based on very low to low-quality evidence.1,4,11 Based on the guidelines’ recommendations, nurses specialized in wound, ostomy, and continence care play a critical role in providing care for individuals at risk for developing a parastomal hernia and should help assess, advise, and educate patients on hernia support garments.1,4,11 The patient we engaged with echoed the importance of nurses specializing in wound, ostomy, and continence care in our conversation. Overall, the target population for each of the evidence-based guidelines was broad, which makes the recommendations generalizable to most individuals who have or are at risk of a parastomal hernia postostomy.1,4,11 Additionally, because 2 of the guidelines were developed for use in Canada, they directly apply to this setting.1,4
To date, most of the research around hernia support garments is qualitative or descriptive. While this can provide important insights into the perspectives and experiences of individuals who use these garments, we cannot provide conclusions on the clinical or cost-effectiveness of hernia support garments versus alternative hernia prevention or management interventions. High-quality clinical studies are needed to inform conclusions about the potential benefits of these garments, such as parastomal hernia prevention or impact on quality of life. Based on the dialogue from our patient engagement activities, it would be valuable for future clinical research to examine health-related quality-of-life outcomes specifically. Both physical outcomes, such as the ability to engage in physical activity, and mental health outcomes, such as well-being, are important to consider. Adverse events such as pain and discomfort related to garment wear are also important to explore. Additionally, studies that compare the benefits and harms of different types of belts, or no belt at all, could also provide valuable insight into patient preference around hernia support garments and the types of garments may be most appropriate for patient use.
It is also important to better understand the cost's role in using these garments. The price of hernia support garments can vary, and the garment will likely need to be replaced 1 or more times per year depending on how frequently it is worn.4 We heard in our patient engagement dialogue that the individual replaces 1 of his belts every 2 to 3 months and his other belt 1 to 2 times per year. Every time the patient replaces their belt they must pay out of pocket. An important implication of this is that people of lower socioeconomic status may have difficulty accessing hernia support garments.
Finally, higher quality clinical studies could also result in more robust and detailed recommendations, such as guidance on the best material or width of garment to use depending on the patient, their unique circumstances, and the context in which they would wear the garment.
Association of Coloproctology of Great Britain and Ireland
Nurses Specialized in Wound, Ostomy, and Continence Canada
Registered Nurses’ Association of Ontario
Contributors: Calvin Young, Shannon Hill
Selection of Included Studies.
Characteristics of Included Guidelines.
Note that this table has not been copy-edited.
Strengths and Limitations of Guidelines Using AGREE II.
Note that this table has not been copy-edited.
Summary of Recommendations in Included Guidelines.
Note that this table has not been copy-edited.
Summary of Patient Involvement Using the Guidance for Reporting Involvement of Patients and the Public (version 2) Short Form Reporting Checklist.
The authors would like to sincerely thank the individual who kindly shared his lived experiences and expertise with us, and who preferred to remain anonymous.
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