Electrolyte Profile, Nutritional Status and Ileostomy Formation.

Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036346
• Other study ID #: LarissaUH
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Resection
• Ileostomy

Intervention

Dietary Supplement:
• Oral ?ydration Solution
Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.

Other:
• Advise on calculated oral fluid requirements

• No nutritional advice will be given

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa	Thessaly

Sponsors (2)

Lead Sponsor	Collaborator
Larissa University Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Kanaki M, Malissiova E, Tzovaras G. Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: A Prospective, Randomized, Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):840-846. doi: 10.1097/DCR.0000000000001082. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum electrolyte levels	sodium (mmol/l)	up to 20-40 days postoperatively
Primary	Serum electrolyte levels	potassium (mmol/l)	up to 20-40 days postoperatively
Primary	Serum electrolyte levels	magnesium (mg/dl)	up to 20-40 days postoperatively
Primary	Serum electrolyte levels	chloride (mmol/l)	up to 20-40 days postoperatively
Secondary	Physical findings of dehydration	thirst, dizziness, lethargy, oliguria, dense urine	20 days postoperatively, 40 days postoperatively
Secondary	Biochemical markers reflecting dehydration and renal function	Urea (mg/dl)	20 days postoperativey, 40 days postoperatively
Secondary	Biochemical markers reflecting dehydration and renal function	Creatinine (mg/dl)	20 days postoperativey, 40 days postoperatively
Secondary	Anthropometric characteristics	weight (kg)	baseline, 40 days postoperatively
Secondary	Anthropometric characteristics	height (m)	baseline, 40 days postoperatively
Secondary	Anthropometric characteristics	BMI (kg/m2)	baseline, 40 days postoperatively
Secondary	Anthropometric characteristics	total body fat (%)	baseline, 40 days postoperatively
Secondary	Nutritional Intake	Energy intake assessed through 24hour recalls and analyzed via nutrition analysis software	baseline, at 20 days and 40 days postoperatively
Secondary	Nutritional Intake	Macronutrient intake assessed through 24hour recalls and analyzed via nutrition analysis software	baseline, at 20 days and 40 days postoperatively
Secondary	Nutritional Intake	Electrolyte intake via diet assessed through 24hour recalls and analyzed via nutrition analysis software	baseline, at 20 days and 40 days postoperatively
Secondary	Stoma output (ml/L)		baseline, at 20 days and 40 days postoperatively

External Links

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