Abstract
Purpose
High output is a common complication after stoma formation. Although the management of high output is described in the literature, there is a lack of consensus on definitions and treatment. Our aim was to review and summarise the current best evidence.
Methods
MEDLINE, Cochrane Library, BNI, CINAHL, EMBASE, EMCARE, and ClinicalTrials.gov were searched from 1 Jan 2000 to 31 Dec 2021 for relevant articles on adult patients with a high-output stoma. Patients with enteroatmospheric fistulas and case series/reports were excluded. Risk of bias was assessed using RoB2 and MINORS. The review was registered in PROSPERO (CRD42021226621).
Results
The search strategy identified 1095 articles, of which 32 studies with 768 patients met the inclusion criteria. These studies comprised 15 randomised controlled trials, 13 non-randomised prospective trials, and 4 retrospective cohort studies. Eighteen different interventions were assessed. In the meta-analysis, there was no difference in stoma output between controls and somatostatin analogues (g − 1.72, 95% CI − 4.09 to 0.65, p = 0.11, I2 = 88%, t2 = 3.09), loperamide (g − 0.34, 95% CI − 0.69 to 0.01, p = 0.05, I2 = 0%, t2 = 0) and omeprazole (g − 0.31, 95% CI − 2.46 to 1.84, p = 0.32, I2 = 0%, t2 = 0). Thirteen randomised trials showed high concern of bias, one some concern, and one low concern. The non-randomised/retrospective trials had a median MINORS score of 12 out of 24 (range 7–17).
Conclusion
There is limited high-quality evidence favouring any specific widely used drug over the others in the management of high-output stoma. Evidence, however, is weak due to inconsistent definitions, risk of bias and poor methodology in the existing studies. We recommend the development of validated core descriptor and outcomes sets, as well as patient-reported outcome measures.
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Data availability
The authors declare that all relevant data used to conduct this review are included in the manuscript and the accompanying supplements.
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NJS and IRD had the initial idea for the review. All authors contributed to the study’s conception and design. HL, VEK and MRSS performed the literature search. HL, VEK and AES performed study selection and data extraction. HL, LHM and FMD performed the risk of bias assessment. The first draft of the manuscript was written by HL and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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IRD is the Honorary President of the UK registered charity Colostomy UK and on the editorial board of Techniques in Coloproctology. All other authors declare no conflict of interest.
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Supplementary Fig. 1
. Contour-enhanced funnel plots, trim & fill analysis and limit meta-analysis. a Contour-enhanced funnel plot for loperamide vs. control; b trim & fill funnel plot for loperamide vs. control; c contour-enhanced funnel plot for somatostatin analogues vs. control; d trim & fill funnel plot for somatostatin analogues vs. control; e contour-enhanced funnel plot for omeprazole vs. control; f trim & fill adjusted results; g limit meta-analysis adjusted results. K number of trials including additionally imputed trials in the trim & fill analysis, SMD standardised mean difference, 95% CI 95% confidence interval, PI prediction interval (PDF 888 KB)
Supplementary Fig. 2
. Leave-one-out meta-analysis of somatostatin analogues vs. control. Recalculation of the meta-analysis K times, each time leaving out one study. K number of trials included in the meta-analysis. θ(hat) = estimated effect size. The dotted line and shaded area represent the original meta-analysis’s pooled effect size and 95% confidence interval (PDF 476 KB)
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Lederhuber, H., Massey, L.H., Kantola, V.E. et al. Clinical management of high-output stoma: a systematic literature review and meta-analysis. Tech Coloproctol 27, 1139–1154 (2023). https://doi.org/10.1007/s10151-023-02830-1
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DOI: https://doi.org/10.1007/s10151-023-02830-1