Introduction
The evidence guiding management of patients with inflammatory bowel disease (IBD) and permanent ileostomy (PI) is limited. We aimed to summarize the evidence for interventional studies related to adjunctive ostomy care including management of high stoma output, skin care, stoma appliances, adhesives, behavioural interventions, mental health, diet, nutrition and disease recurrence.
Aims & Methods
MEDLINE, Embase, and Cochrane CENTRAL were searched from inception to January 5, 2024. Eligible studies were randomized controlled trials (RCTs), non-randomized controlled studies, or comparative cohort studies in English. Studies predominantly recruiting participants with ulcerative colitis (UC) and/or Crohn’s disease (CD) with PI were considered. Studies assessing temporary ileostomy, and ostomies other than PI such as colostomy, urostomy, and jejunostomy were excluded.
Results
A total of 3217 records were identified and independently screened of which six studies were eligible (Table 1). Five studies were published more than 20 years ago (1976-2003) with a small sample size (ranged from 8 to 40). Five studies were double blind RCTs with four studies incorporating a cross over design, and one was non-blinded RCT with a cross over design. Two studies exclusively included patients with UC, one study included CD and the remaining three studies included both UC and CD. No studies included patients with active CD. Four studies assessed pharmacological interventions (loperamide, 5-aminosalysilate [5-ASA], azodisal sodium, and oral budesonide), one assessed oral supplement with different osmolarities and one assessed dietary intervention (unrefined vs. refined carboyhdyrate). Decrease in ileostomy output was primary outcome of interest in four studies (Loperamide, budesonide and azodisal sodium). Outcomes of the remaining two studies include changes in microbial composition and bile acid excretion. Loperamide and budesonide were associated with decreased stoma output. In a study assessing dietary intervention, patients receiving diet rich in unrefined carbohydrates had a ten-fold increase in bacterial load in stoma output compared to patients on a diet rich in refined carbohydrates. One study reported no difference in stoma output between iso- and hyper-osmolar supplements but iso-osmolar supplements were associated with increased natriuresis. The remaining studies were designed to explore the effect of 5-ASAs on ileostomy output in patients with UC and PI.
Conclusion
This study highlights that the evidence base to inform care for patients with IBD and PI is almost non-existent. There is an urgent need for focused research in this area to inform evidence-based treatment decisions. The items identified in this review as well as knowledge gaps will inform consensus steps for development of future care pathways and expert guidelines.
Table 1. Characteristics of interventional studies conducted in patients of inflammatory bowel disease and permanent ileostomy
| Authors, Year | Country | Study design | Number of participants | IBD subclass (n) | Intervention | Control | Outcomes | Conclusions |
Tytgat,
1976
| Netherlands | Double-blinded, RCT, cross over | 20, ileostomy (total colonic resections with PI) | UC (12)
CD (5)
Polyposis coli (2)
Adenocarcinoma (1) | Loperamide 8mg/day (first four days) and were allowed to increase the dose to 12mg/day for the next 3 days) | Placebo
| Ileostomy fecal output | Daily fecal outputs were significantly lower with loperamide compared to placebo |
| Berghouse, 1984 | United Kingdom | Unblinded, randomized, cross over,
| 10 patients with ileostomies | CD (5)
UC (5)
| Diet rich in refined carbohydrates | Diet with unrefined carbohydrates | Microbial composition of ileostomy output | Approximately 10-fold increase of total bacteria per gram of effluent when patients were on diet with unrefined carbohydrates.
Significantly low wet and dry weight of ileostomy out put with diet rich in refined carbohydrates |
| Sandberg-Gertzen, 1986 | Denmark | Double-blinded RCT, placebo-controlled cross over | 8 patients who underwent colectomy with a PI | UC | Azodisal sodium (1 g/day vs 2 g/day) or sulphasalazine (2 g/day) given for five day periods | placebo | Ileostomy fluid output.
Prostaglandin levels in ileostomy out put | Azodisal sodium but not sulfasalazine was associated with increased ileostomy output and was dose related.
Azodisal sodium was not associated with increased prostaglandin levels in ileostomy output. |
Jarnerot, 1988
| Sweeden | Double-blinded, placebo-controlled RCT cross over | 8 patients who underwent colectomy with a PI | UC | Olsalazine sodium 0.75g twice a day | Placebo | Bile acids in ileostomy output | Bile acid excretion was not significant different between Olsalazine and placebo |
| Ecker, 2003 | Germany | Double-blinded RCT | 40 patients with ileostomy and with a high ileostomy output (>1000 ml/24) | CD | Oral budesonide 3mg tid x 8 days | Placebo | A >25% reduction in intestinal output during
treatment was defined as response | 60% (12/20) of patients showed a
Response compared to none in placebo group.
30.2% decrease in median output was seen in budesonide group compared to 0.3% decrease in placebo group |
| Rud, 2019 | Denmark | Double- blinded, active comparator-controlled RCT cross over | 8 patients with ileostomy and independent of parenteral nutrition | UC (5)
CD (2)
Cancer (1) | Iso-osmolar
(279 mOsm/kg) oral supplement
200ml x 4 times a day for two days | Hyper-osmolar (681 mOsm/kg) oral supplement
200ml x 4 times a day for two days | Difference in ileostomy output | No statistically significant changes in ileostomy output. Iso-osmolar supplement induced a statistically significant increase in urine volume and natriuresis |
CD: Crohn’s disease, PI: permanent ileostomy, RCT: randomized controlled trial, UC: ulcerative colitis.
Disclosure
SKV none
VS has none to disclose.
YY has none to disclose
NN has been a speaker or advisor for Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Fresenius Kabi, Innomar, Iterative Scopes, Bristol Myers Squibb, Viatris and Ferring
SS has received consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenixa, UCB Inc, and Vifor; and lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc, Gilead, Janssen, Mylan, Pfizer, and Takeda.
CM has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche, Sanofi; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Takeda, Pendopharm, and Pfizer; royalties from Springer Publishing; research support from Ferring, Takeda, Pfizer.
FR is consultant to Adnovate, Agomab, Allergan, AbbVie, Arena, Boehringer-Ingelheim, Celgene/BMS, CDISC, Celsius, Cowen, Ferring, Galapagos, Galmed, Genentech, Gilead, Gossamer, Guidepoint, Helmsley, Horizon Therapeutics, Image Analysis Limited, Index Pharma, Jannsen, Koutif, Mestag, Metacrine, Mopac, Morphic, Organovo, Origo, Pfizer, Pliant, Prometheus Biosciences, Receptos, RedX,Roche, Samsung, Surmodics, Surrozen, Takeda, Techlab, Theravance, Thetis, UCB, Ysios, 89Bio.
VJ has received consultancy/advisory board fees from AbbVie, Alimentiv Inc., Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Ventyx, and Vividion; and speaker’s fees from, Abbvie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, and Fresenius Kabi.