Correspondence to Professor Zhanlin Luo; [email protected]
STRENGTHS AND LIMITATIONS OF THIS STUDY
This protocol will strictly adhere to the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.
The literature search will include only English and Chinese literature from the past 10 years, potentially limiting the comprehensiveness of the search. However, researchers will broaden the search scope based on the included literature and supplement it by searching grey literature.
The Grading of Recommendations, Assessment, Development and Evaluation and Risk Of Bias In Non-randomised Studies of Interventions tools will be used to grade the quality of the evidence obtained after quality evaluation, ensuring the scientific rigour of the research design and the appropriateness of evidence classification.
To reduce the risk of bias, researchers will triple-check the input data during the process of literature quality evaluation and evidence summarisation.
Introduction
In recent years, with the rapid development of living standards, people’s eating habits and lifestyles have undergone major changes, leading to a continuously increasing trend in the incidence and mortality of malignant tumours such as gastric cancer and colorectal cancer.1 The treatment of colorectal cancer predominantly involves surgery, and the number of patients undergoing enterostomy is on the rise.2 Enterostomy requires the removal of the cancerous end of the intestine, extraction of a section of the intestine through the abdominal incision, and its attachment to the abdominal wall skin to form a stoma.3 As the anal sphincter loses its normal excretion function, patients must use a stoma bag to collect excreta postsurgery. In the USA, approximately 100 000 patients undergo enterostomy annually, with a current total of 1 million enterostomy patients.4 Despite rapid advancements in surgical techniques, the incidence of high output in enterostomy patients ranges from 23.8% to 31.1% compared with other common surgical procedures.5 6
Postoperative complications of enterostomy can be categorised into early and advanced complications based on the time of occurrence. Early complications refer to those occurring within the first 30 days postoperation. High output is a prevalent early complication of enterostomy.7 Typically, the output from an enterostomy ranges from 500 to 2000 mL but varies based on the type of stoma, enteral feedings and other factors. A review of extensive literature reveals ambiguity in the normal output for different types of enterostomies; however, it is widely accepted that an output exceeding 1500 mL per day from a small bowel enterostomy is considered high.8 Fluid losses postsurgery usually resolve within a few weeks due to adaptive changes in the remaining small intestine. In some patients, high-output enterostomy results from inadequate adaptation or other causes of diarrhoea, such as indigestible food intake, leading to significant water and electrolyte loss, and potentially causing complications like kidney function injury.9 High output is also the most common reason affecting readmissions of enterostomy patients.10 Moreover, the quality of life for patients with enterostomy is poor in the early stages due to insufficient knowledge about stoma care and influences such as psychological emotions.11 Overall, the risk of postoperative complications after enterostomy is lifelong, with high output being a frequent complication. Specialist stoma nurses should proactively focus on complication prevention and provide guidance.
Currently, the literature on preventing high output has not received adequate attention, and there is no consensus to guide precise and effective nursing interventions for preventing high output in enterostomy patients. Monitoring of enterostomy discharge is also often overlooked by patients and clinical ostomy nurses. Additionally, the variable quality of relevant literature can waste medical resources and lead to misleading clinical practices.
Given these issues, it is urgent to determine a comprehensive and effective prevention programme for high output. The scoping review, based on evidence-based concepts, aims to help researchers understand the scope and characteristics of existing evidence and identify gaps in the evidence. Thus, the methods employed in this study were designed to retrieve, summarise and analyse relevant evidence on high output in enterostomy patients, providing an evidence-based foundation for clinical nurses, patients and caregivers to implement enterostomy care and reduce the incidence of high output.
The review
Review questions
What are the risk factors for high output enterostomy?
What are the critical evaluation contents of high-output enterostomy?
What are the main interventions that can effectively prevent high-output enterostomy?
Methods
This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.12 13 The study is scheduled to commence in April 2024 and conclude in August 2024. This protocol has been registered with the OSF (https://doi.org/10.17605/OSF.IO/UF9B7).
Patient and public involvement
No patients and the public were involved.
Context
Inclusion criteria
The subjects are patients who have undergone enterostomy (including colostomy, ileostomy, cecostomy, jejunostomy, etc) after a pathological diagnosis of malignant diseases such as stomach and colorectal cancer. The patients are 18 years or older. Enterostomy in children is excluded due to factors such as the thin cuticle of the skin, crying and different ostomy bag management needs. Additionally, children undergoing enterostomy often have various congenital diseases, such as anal absence and Hirschsprung’s disease, which differ significantly from adult enterostomy. Finally, the rehabilitation outcomes for minor enterostomy patients depend on the effectiveness of care provided by primary caregivers, which is a further reason for their exclusion from this study.
Exclusion criteria
The subjects are patients undergoing urostomy.
Conference abstracts, animal experiments or preclinical trial studies and studies without specifying the type of stoma.
Studies where the full text is not available.
Studies with incomplete data and unsuccessful attempts to contact the original authors.
Concept
The objective of this scoping review is to search, select and extract evidence for the prevention and care of high-output enterostomy patients. According to the requirements of different databases, appropriate search strategies will be developed, and a literature search will be conducted. The data that meet the inclusion criteria will be analysed. The main contents include (1) risk factors for high-output enterostomy patients; (2) critical evaluation contents of high-output enterostomy, such as symptoms and signs of high output in enterostomy patients and (3) interventions that can effectively prevent and improve high output.
Types of studies
The literature types included in this study encompass randomised controlled trials (RCTs), non-RCTs, cohort studies, case–control studies, cross-sectional studies, observational studies and descriptive studies. Qualitative studies and systematic reviews will also be considered and published in either English or Chinese, from January 2015 to January 2024. This review will include studies on high-output enterostomy conducted in any country or region.
Search strategy
The search for studies related to the prevention of high output in adult enterostomy patients will be conducted through PubMed, EMBASE, CINAHL, the Chinese Biological Literature Database and the Cochrane Library. We will employ the following MeSH terms and/or free-text terms: surgical stomas, enterostomy, ostomy, stoma, ileostomy, jejunostomy, colostomy, high output, fast transit, diarrhoea, risk factor, association, relative risk, factor, influence, correlation, management, treatment, therapy and care.
Additionally, grey literature sources, such as Google Scholar, will be searched to ensure comprehensive evidence incorporation. Grey literature includes materials published by government departments, academic institutions and commercial industries that are non-profit, helping to avoid publication bias. The flow chart of the study diagram is presented in figure 1, and the detailed search strategy is outlined in online supplemental appendix S1.
Literature screening
The literature screening will be conducted independently and cross-checked by two reviewers (Che Y and Luo ZL). In the event of disagreements, decisions will be discussed in a group meeting. The reviewers will independently use EndNote V.X9 software to remove duplicate entries and initially exclude irrelevant literature by reviewing titles and abstracts. For literature retained after this initial screening, further exclusions will be made by reading the full text to ensure alignment with the study theme, such as research object consistency and intervention plans.
Data extraction and presentation
Two reviewers (Che Y and Luo ZL) will independently extract data, including (1) research design, title, author, year of publication, types of literature, country or region of publication, and publication languages; (2) baseline characteristics of participants: sample size, gender, age, type of enterostomy, characteristics of the research population; (3) intervention details: intervention measures, observation period and (4) primary outcomes: the incidence of high-output enterostomy, enterostomy output volume, the change of output and the factors contributing to high-output enterostomy. There will be no secondary outcome measures.
Strategy for data synthesis
The study design, baseline characteristics of participants and intervention details of this scoping review will be quantitatively summarised in table format. For the incidence of high output in enterostomy, enterostomy output volume, changes in output and factors contributing to high-output enterostomy will be presented in the form of frequency, percentage and descriptive summary.
Quality of evidence
The quality of evidence for outcome indicators will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.14 The GRADE evaluation criteria include five grading factors: research limitations, inconsistency, indirectness, imprecision and publication bias. The evidence quality will be rated across four levels: high, moderate, low and very low. The default evidence quality for RCTs is high, with one grade reduction to moderate, two reductions to low and three to very low.
For cohort studies, case–control studies and other non-RCTs included in this review, the risk of bias will be assessed using the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool.15 ROBINS-I tool divides bias into 7 domains with a total of 33 items: (1) confounding bias; (2) subject selection bias; (3) intervention classification bias; (4) intentional intervention deviation bias; (5) loss of data bias; (6) outcome measurement bias and (7) selective reporting bias. According to the evaluation results of each item, the researcher will make yes (Y), probably yes (PY), no (N), probably no (PN) and no information (NI) answers. ROBINS-I divided the evaluation results into five levels: low risk of bias, moderate risk of bias, high risk of bias, critical risk of bias and no information.
Ethics statements
Patient consent for publication
Not applicable.
Ethics approval
Since the literature related to the research topic will be obtained by searching the database for analysis in this scoping review, informed consent and ethical approval of patients will not be required. The results of this study will provide decision-making information for researchers, clinicians, and other ostomy nursing staff. The results of the review will be presented at a scientific conference and published in a peer-reviewed journal.
Contributors All authors in the manuscript contributed substantially to the idea or design of the study and agreed to the manuscript’s publication; YC and SL: literature search and data extraction; YC and FS: quality assessment of systematic reviews and writing of papers; ZL: search literature and quality assessment of systematic reviews; TW and CG: search literature and quality assessment of systematic reviews; YC: design study and data extraction.
Funding This scoping review protocol was supported by Natural Science Foundation of Gansu Province, China (22JR5RA697).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
1 Zhou L, Zhang F, Li H, et al. Post-discharge health education for patients with enterostomy: A nationwide interventional study. J Glob Health 2023; 13: 04172. doi:10.7189/jogh.13.04172
2 Du X, Jiang H, Fu L, et al. Development and validation of a self-management behavior questionnaire for Chinese enterostomy patients. Int J Nurs Sci 2022; 9: 252–8. doi:10.1016/j.ijnss.2022.03.007
3 Burch J. The community nurse and stoma care. Br J Community Nurs 2022; 27: 165–8. doi:10.12968/bjcn.2022.27.4.165
4 Ayik C, Özden D, Cenan D. Ostomy Complications, Risk Factors, and Applied Nursing Care: A Retrospective, Descriptive Study. Wound Manag Prev 2020; 66: 20–30.
5 Takeda M, Takahashi H, Haraguchi N, et al. Factors predictive of high-output ileostomy: a retrospective single-center comparative study. Surg Today 2019; 49: 482–7. doi:10.1007/s00595-018-1756-2
6 Hara Y, Miura T, Sakamoto Y, et al. Organ/space infection is a common cause of high output stoma and outlet obstruction in diverting ileostomy. BMC Surg 2020; 20: 83. doi:10.1186/s12893-020-00734-7
7 Babakhanlou R, Larkin K, Hita AG, et al. Stoma-related complications and emergencies. Int J Emerg Med 2022; 15: 17. doi:10.1186/s12245-022-00421-9
8 Wyer N. Dietary management of patients with a high-output stoma. Nurs Stand 2022; 37: 71–6. doi:10.7748/ns.2022.e11941
9 Lederhuber H, Massey LH, Kantola VE, et al. Clinical management of high-output stoma: a systematic literature review and meta-analysis. Tech Coloproctol 2023; 27: 1139–54. doi:10.1007/s10151-023-02830-1
10 Nightingale JMD. How to manage a high-output stoma. Frontline Gastroenterol 2022; 13: 140–51. doi:10.1136/flgastro-2018-101108
11 Vogel I, Shinkwin M, van der Storm SL, et al. Overall readmissions and readmissions related to dehydration after creation of an ileostomy: a systematic review and meta-analysis. Tech Coloproctol 2022; 26: 333–49. doi:10.1007/s10151-022-02580-6
12 Dulskas A, Petrauskas V, Kuliavas J, et al. Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial. J Clin Med 2021; 10: 768. doi:10.3390/jcm10040768
13 Peters MDJ, Godfrey C, McInerney P, et al. Chapter 11: scoping reviews. In: Aromataris E, Munn Z, eds. JBI Manual for Evidence Synthesis [internet]. Adelaide, JBI, 2020. Available: https://synthesismanual.jbi.global
14 Tricco AC, Lillie E, Zarin W, et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med 2018; 169: 467–73. doi:10.7326/M18-0850
15 Mendoza Pinto C, García Carrasco M. GRADE system, systematic and transparent evaluation. Sistema GRADE, evaluación sistemática y transparente. Reumatol Clin. Environ Int 2018; 120: 382–7. doi:10.1016/j.reuma.2017.07.010
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Abstract
Introduction
The purpose of this protocol is to investigate the risk factors, critical evaluation contents and preventive measures of high-output enterostomy.
Methods and analysis
This scoping review will follow the Joanna Briggs Institute guidelines for scoping reviews. PubMed, EMBASE, CINAHL, the Chinese Biological Literature Database and the Cochrane Library will be searched for relevant literature published from January 2015 to January 2024. The Grading of Recommendations, Assessment, Development and Evaluation and the Risk Of Bias In Non-randomised Studies of Interventions will be used to assess the reliability of the evidence.
Ethics and dissemination
As this scoping review involves database searches for literature analysis, informed consent and ethical approval from patients will not be required. The findings will provide essential decision-making information for researchers, clinicians and ostomy nursing staff. The results of the review will be presented at a scientific conference and published in a peer-reviewed journal.
You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer
Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by using the translation functionality you agree to forgo any and all claims against ProQuest or its licensors for your use of the translation functionality and any output derived there from. Hide full disclaimer
Details

1 Research Ward, Gansu Provincial Hospital, Lanzhou, China
2 Gansu University Of Chinese Medicine, Lanzhou, China
3 Department of radiotherapy, Gansu Provincial People's Hospital, Lanzhou, China
4 Gansu Provincial Hospital, Lanzhou, Gansu, China
5 Department of radiotherapy, Gansu Provincial Hospital, Lanzhou, Gansu, China