Electrolyte Profile, Nutritional Status and Ileostomy Formation.
- Conditions
- Colorectal ResectionIleostomy
- Interventions
- Other: Advise on calculated oral fluid requirementsDietary Supplement: Oral Ηydration SolutionOther: No nutritional advice will be given
- Registration Number
- NCT02036346
- Lead Sponsor
- Larissa University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- Male of female patients of more than 18 years of age
- Patients who have undergone a rectosigmoidectomy procedure resulting or not in an ileostomy formation
- Short Bowel Syndrome
- Diabetic ketoacidosis
- Chronic Renal failure
- Hepatic/Cardiac failure
- Diabetes insipidus
- Diuretic Medication
- Corticosteroid Medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No intervention Advise on calculated oral fluid requirements Patients who have undergone colorectal resection surgery resulting in an ileostomy creation Oral rehydration solution Oral Ηydration Solution Patients who have undergone colorectal resection surgery resulting in an ileostomy creation Colorectal resection without an ileostomy No nutritional advice will be given Patients who have undergone colorectal resection surgery without an ileostomy creation
- Primary Outcome Measures
Name Time Method Serum electrolyte levels up to 20-40 days postoperatively chloride (mmol/l)
- Secondary Outcome Measures
Name Time Method Physical findings of dehydration 20 days postoperatively, 40 days postoperatively thirst, dizziness, lethargy, oliguria, dense urine
Biochemical markers reflecting dehydration and renal function 20 days postoperativey, 40 days postoperatively Creatinine (mg/dl)
Anthropometric characteristics baseline, 40 days postoperatively total body fat (%)
Nutritional Intake baseline, at 20 days and 40 days postoperatively Electrolyte intake via diet assessed through 24hour recalls and analyzed via nutrition analysis software
Stoma output (ml/L) baseline, at 20 days and 40 days postoperatively
Trial Locations
- Locations (1)
University Hospital of Larissa
🇬🇷Larissa, Thessaly, Greece