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| Name | Class |
|---|---|
| University of Thessaly | OTHER |
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One of the main reasons for hospital readmission in ileostomy patients is fluid and electrolyte abnormalities. Prospective observational studies have suggested an occurrence rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium and fluid through their stoma effluent. In addition studies have shown that ileostomy construction is a risk factor for renal impairment, occurring secondary to dehydration.
Encouraging patients to increase total fluid intake seems to be a common mistake in clinical practice as this can dilute sodium levels even more, causing greater sodium depletion. In terms of addressing the problem a few small studies have used isotonic drinks of various compositions showing increased electrolyte absorption.
Other dietary complications sometimes include hypomagnesaemia and decreased absorption of B-12 and folic acid, however due to the integrity of the small intestine other nutrient malabsorption is unlikely to occur. As far as body composition is concerned obesity has been shown to be a risk factor for peri- and postoperative complications in colorectal surgery (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining measures that can prevent readmission for dehydration and other nutritional considerations related to this group of patients is definitely required.
Hypothesis:
The administration of an oral rehydration solution will allow a significant decrease in dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral rehydration solution | Experimental | Patients who have undergone colorectal resection surgery resulting in an ileostomy creation |
|
| No intervention | Experimental | Patients who have undergone colorectal resection surgery resulting in an ileostomy creation |
|
| Colorectal resection without an ileostomy | Active Comparator | Patients who have undergone colorectal resection surgery without an ileostomy creation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Ηydration Solution | Dietary Supplement | Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum electrolyte levels | sodium (mmol/l) | up to 20-40 days postoperatively |
| Serum electrolyte levels | potassium (mmol/l) | up to 20-40 days postoperatively |
| Serum electrolyte levels | magnesium (mg/dl) | up to 20-40 days postoperatively |
| Serum electrolyte levels | chloride (mmol/l) | up to 20-40 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Physical findings of dehydration | thirst, dizziness, lethargy, oliguria, dense urine | 20 days postoperatively, 40 days postoperatively |
| Biochemical markers reflecting dehydration and renal function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GEORGE TZOVARAS, MD | University Hospital of Larissa | Study Chair |
| GEORGE TZOVARAS, MD | University Hopsital of Larissa | Study Director |
| Georgios D Koukoulis, M.D. MSc PhD | Department of General Surgery, University Hospital of Larisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larissa | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29771807 | Background | Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Kanaki M, Malissiova E, Tzovaras G. Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: A Prospective, Randomized, Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):840-846. doi: 10.1097/DCR.0000000000001082. | |
| 33183563 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Advise on calculated oral fluid requirements | Other |
|
| No nutritional advice will be given | Other |
|
Urea (mg/dl)
| 20 days postoperativey, 40 days postoperatively |
| Biochemical markers reflecting dehydration and renal function | Creatinine (mg/dl) | 20 days postoperativey, 40 days postoperatively |
| Anthropometric characteristics | weight (kg) | baseline, 40 days postoperatively |
| Anthropometric characteristics | height (m) | baseline, 40 days postoperatively |
| Anthropometric characteristics | BMI (kg/m2) | baseline, 40 days postoperatively |
| Anthropometric characteristics | total body fat (%) | baseline, 40 days postoperatively |
| Nutritional Intake | Energy intake assessed through 24hour recalls and analyzed via nutrition analysis software | baseline, at 20 days and 40 days postoperatively |
| Nutritional Intake | Macronutrient intake assessed through 24hour recalls and analyzed via nutrition analysis software | baseline, at 20 days and 40 days postoperatively |
| Nutritional Intake | Electrolyte intake via diet assessed through 24hour recalls and analyzed via nutrition analysis software | baseline, at 20 days and 40 days postoperatively |
| Stoma output (ml/L) | baseline, at 20 days and 40 days postoperatively |
| Derived |
| Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Vagena X, Malissiova E, Tzovaras G. The effect of a diverting ileostomy formation on nutritional status and energy intake of patients undergoing colorectal surgery. Clin Nutr ESPEN. 2020 Dec;40:357-362. doi: 10.1016/j.clnesp.2020.08.002. Epub 2020 Aug 28. |
| D013568 | Pathological Conditions, Signs and Symptoms |