A Randomized Controlled Trial to Study the Effects of Loperamide on the Fluid and Electrolyte Balance in Patients Undergoing an Ileostomy

Abstract

Ileostomy is an artificial opening in the ileum to divert intestinal contents outside the abdomen. The complications arising from an ileostomy are frequent and range from a mild inconvenience to life-threatening. One of the most troublesome complications is ileostomy diarrhoea, which affects the fluid and electrolyte balance. The aim of the study was to determine the effect of loperamide on stoma output and serum electrolytes in patients with newly formed ileostomy. This study was done as a double-blinded, randomized controlled method. The study included 42 patients who fulfilled the inclusion criteria. All of the patients underwent an ileostomy at the institute. In the post-operative period, patients were given either loperamide or placebo and monitored. The ileostomy output was recorded over every 24 h; renal functions and electrolyte levels were checked every 1, 3, 5, 7, 14 and 28th post-operative days. The concomitant use of antidiarrheals including codeine containing analgesics and anticholinergics was forbidden. There was significant decrease in the stoma output in patients who received loperamide as compared to placebo (p < 0.05). There was no statistical difference between the serum potassium, sodium and creatinine levels. The incidence of post-operative gastrointestinal complications was higher in the loperamide group but not statistically significant and these could be managed conservatively without any change in treatment protocol (47.6% vs 33.34%). The incidence of post-operative stomal complications was higher in the placebo group but with no statistical significance (23% vs 14.2%). Loperamide significantly reduced the stoma output and helped in fluid regulation of patients with a newly formed ileostomy. There was no statistical difference in the electrolyte levels in patients treated with oral loperamide and placebo. The dosage can be altered if gastrointestinal complications are encountered, although they usually are self-limiting and do not require a change in the treatment plan. Oral loperamide may be used in patients with a newly formed ileostomy in the early post-operative period.