Electrolyte Profile, Nutritional Status and Ileostomy Formation.

Study Overview
=================
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.

Official Title
-----------------
The Effect of Ileostomy Formation on Nutritional Status and Electrolyte Profile in Rectosigmoidectomy Patients: a Prospective Randomized Trial.

Conditions
-----------------
Colorectal Resection, Ileostomy

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Ηydration Solution
* Other: Advise on calculated oral fluid requirements
* Other: No nutritional advice will be given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Short Bowel Syndrome Diabetic ketoacidosis Chronic Renal failure Hepatic/Cardiac failure Diabetes insipidus Diuretic Medication Corticosteroid Medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral rehydration solution<br>Patients who have undergone colorectal resection surgery resulting in an ileostomy creation | Dietary Supplement: Oral Ηydration Solution<br>* Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.<br>|
| Experimental: No intervention<br>Patients who have undergone colorectal resection surgery resulting in an ileostomy creation | Other: Advise on calculated oral fluid requirements<br> <br> |
| Active Comparator: Colorectal resection without an ileostomy<br>Patients who have undergone colorectal resection surgery without an ileostomy creation | Other: No nutritional advice will be given<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ileostomy, colorectal resection, dehydration, nutritional status