Electrolyte Profile, Nutritional Status and Ileostomy Formation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2018-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Resection Ileostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Oral rehydration solution

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

Group Type EXPERIMENTAL

Oral Ηydration Solution

Intervention Type DIETARY_SUPPLEMENT

Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.

No intervention

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

Group Type EXPERIMENTAL

Advise on calculated oral fluid requirements

Intervention Type OTHER

Colorectal resection without an ileostomy

Patients who have undergone colorectal resection surgery without an ileostomy creation

Group Type ACTIVE_COMPARATOR

No nutritional advice will be given

Intervention Type OTHER

Interventions

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Oral Ηydration Solution

Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.

Intervention Type DIETARY_SUPPLEMENT

Advise on calculated oral fluid requirements

Intervention Type OTHER

No nutritional advice will be given

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No