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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02036346
Other study ID # LarissaUH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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