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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Chemical colostomy irrigation with glyceryl trinitrate solution.
Diseases of the Colon and Rectum 2001 September
PURPOSE: Colostomy irrigation may improve patient quality of life, but is time consuming. This study tests the hypothesis that irrigation with glyceryl trinitrate solution, by inducing gastrointestinal smooth muscle relaxation, may accelerate expulsion of stool by passive emptying, thereby reducing irrigation time.
METHODS: Fifteen colostomy irrigators(with more than 3 years' experience) performed washout with tap water compared with water containing 0.025 mg/kg glyceryl trinitrate. Fluid inflow time, total washout time, and hemodynamic changes occurring during glyceryl trinitrate irrigation were documented by an independent observer. Subjects recorded episodes of fecal leakage and overall satisfaction on a visual analog scale. Cramps, headaches, and whether or not a stoma bag was used were expressed as a percentage of number of irrigations. Comparison of fluid inflow time, total washout time, leakage, and satisfaction was by Wilcoxon's signed-rank test and headaches, cramps, and stoma bag use was by McNemar's test. Pulse rate (paired t-test), systolic and diastolic blood pressures (Wilcoxon's test) at 20 and 240 minutes after washout with glyceryl trinitrate solution were compared with baseline.
RESULTS: Fifteen patients (9 female), with a mean age of 53 (31-73) years, provided 30 sessions (15 with water and 15 with glyceryl trinitrate). Medians (interquartile ranges) for water vs. glyceryl trinitrate were fluid inflow time 7 (4-10) vs. 4, (3-5; P = 0.001); total washout time 40 (30-55) vs. 21, (15-24; P < 0.001); leakage 0 (0-1) vs. 0, (0-0; P = 0.02), satisfaction 10 (8-10) vs. 10 (9-10; P = 0.31). The number (percentage) of stoma bags, cramps, and headaches with water vs. glyceryl trinitrate were 7 (47 percent) vs. 7 (47 percent), P = 1; 1 (7 percent) vs. 14 (93 percent), P < 0.001; and 0(0 percent) vs. 14 (93 percent), P < 0.001, respectively. Changes in pulse (increase) and systolic and diastolic blood pressures (decrease) from baseline were maximal at 20 minutes (P < 0.001, P = 0.001, and P = 0.002, respectively) and had returned to baseline by 240 minutes (P = 0.52, P = 0.08, and P = 1, respectively).
CONCLUSION: Glyceryl trinitrate solution significantly reduces colostomy irrigation time compared with the generally recommended tap water. Patients suffer fewer leakages and are highly satisfied, but side effects are potential drawbacks. Other colonoplegic agent solutions should now be evaluated.
METHODS: Fifteen colostomy irrigators(with more than 3 years' experience) performed washout with tap water compared with water containing 0.025 mg/kg glyceryl trinitrate. Fluid inflow time, total washout time, and hemodynamic changes occurring during glyceryl trinitrate irrigation were documented by an independent observer. Subjects recorded episodes of fecal leakage and overall satisfaction on a visual analog scale. Cramps, headaches, and whether or not a stoma bag was used were expressed as a percentage of number of irrigations. Comparison of fluid inflow time, total washout time, leakage, and satisfaction was by Wilcoxon's signed-rank test and headaches, cramps, and stoma bag use was by McNemar's test. Pulse rate (paired t-test), systolic and diastolic blood pressures (Wilcoxon's test) at 20 and 240 minutes after washout with glyceryl trinitrate solution were compared with baseline.
RESULTS: Fifteen patients (9 female), with a mean age of 53 (31-73) years, provided 30 sessions (15 with water and 15 with glyceryl trinitrate). Medians (interquartile ranges) for water vs. glyceryl trinitrate were fluid inflow time 7 (4-10) vs. 4, (3-5; P = 0.001); total washout time 40 (30-55) vs. 21, (15-24; P < 0.001); leakage 0 (0-1) vs. 0, (0-0; P = 0.02), satisfaction 10 (8-10) vs. 10 (9-10; P = 0.31). The number (percentage) of stoma bags, cramps, and headaches with water vs. glyceryl trinitrate were 7 (47 percent) vs. 7 (47 percent), P = 1; 1 (7 percent) vs. 14 (93 percent), P < 0.001; and 0(0 percent) vs. 14 (93 percent), P < 0.001, respectively. Changes in pulse (increase) and systolic and diastolic blood pressures (decrease) from baseline were maximal at 20 minutes (P < 0.001, P = 0.001, and P = 0.002, respectively) and had returned to baseline by 240 minutes (P = 0.52, P = 0.08, and P = 1, respectively).
CONCLUSION: Glyceryl trinitrate solution significantly reduces colostomy irrigation time compared with the generally recommended tap water. Patients suffer fewer leakages and are highly satisfied, but side effects are potential drawbacks. Other colonoplegic agent solutions should now be evaluated.
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