Electrolyte Profile, Nutritional Status and Ileostomy Formation.

Not Applicable

Completed

• Conditions: Colorectal Resection; Ileostomy

• 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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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