Electrolyte Profile, Nutritional Status and Ileostomy Formation.

Larissa University Hospital

Status: Completed

Conditions: Colorectal Resection; Ileostomy

Treatments: Dietary Supplement: Oral Ηydration Solution; Other: Advise on calculated oral fluid requirements; Other: No nutritional advice will be given

Study type: Interventional

Funder types: Other

Identifiers

NCT02036346

LarissaUH

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 3 patient groups

Oral rehydration solution

Experimental group

Description:

Patients who have undergone colorectal resection surgery resulting in an ileostomy creation

Treatment:

Dietary Supplement: Oral Ηydration Solution

No intervention

Experimental group

Description:

Patients who have undergone colorectal resection surgery resulting in an ileostomy creation

Treatment:

Other: Advise on calculated oral fluid requirements

Colorectal resection without an ileostomy

Active Comparator group

Description:

Patients who have undergone colorectal resection surgery without an ileostomy creation

Treatment:

Other: No nutritional advice will be given