Electrolyte Profile, Nutritional Status and Ileostomy Formation.

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

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy; Colorectal Resection
• Intervention / Treatment: Dietary supplement: Oral Ηydration Solution; Other: Advise on calculated oral fluid requirements; Other: No nutritional advice will be given

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • University Hospital Of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral rehydration solution; Patients who have undergone colorectal resection surgery resulting in an ileostomy creation	Dietary supplement: Oral Ηydration Solution; Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.
Experimental: No intervention; Patients who have undergone colorectal resection surgery resulting in an ileostomy creation	Other: Advise on calculated oral fluid requirements
Active Comparator: Colorectal resection without an ileostomy; Patients who have undergone colorectal resection surgery without an ileostomy creation	Other: No nutritional advice will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum electrolyte levels	sodium (mmol/l)	up to 20-40 days postoperatively
Serum electrolyte levels	potassium (mmol/l)	up to 20-40 days postoperatively
Serum electrolyte levels	magnesium (mg/dl)	up to 20-40 days postoperatively
Serum electrolyte levels	chloride (mmol/l)	up to 20-40 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical findings of dehydration	thirst, dizziness, lethargy, oliguria, dense urine	20 days postoperatively, 40 days postoperatively
Biochemical markers reflecting dehydration and renal function	Urea (mg/dl)	20 days postoperativey, 40 days postoperatively
Biochemical markers reflecting dehydration and renal function	Creatinine (mg/dl)	20 days postoperativey, 40 days postoperatively
Anthropometric characteristics	weight (kg)	baseline, 40 days postoperatively
Anthropometric characteristics	height (m)	baseline, 40 days postoperatively
Anthropometric characteristics	BMI (kg/m2)	baseline, 40 days postoperatively
Anthropometric characteristics	total body fat (%)	baseline, 40 days postoperatively
Nutritional Intake	Energy intake assessed through 24hour recalls and analyzed via nutrition analysis software	baseline, at 20 days and 40 days postoperatively
Nutritional Intake	Macronutrient intake assessed through 24hour recalls and analyzed via nutrition analysis software	baseline, at 20 days and 40 days postoperatively
Nutritional Intake	Electrolyte intake via diet assessed through 24hour recalls and analyzed via nutrition analysis software	baseline, at 20 days and 40 days postoperatively
Stoma output (ml/L)		baseline, at 20 days and 40 days postoperatively

Collaborators and Investigators

• Sponsor: Larissa University Hospital
• Collaborators: University of Thessaly
• Investigators: Study Director: GEORGE TZOVARAS, MD, University Hopsital of Larissa; Principal Investigator: Georgios D Koukoulis, M.D. MSc PhD, Department of General Surgery, University Hospital of Larisa

Publications and helpful links

General Publications

• 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.
• Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Vagena X, Malissiova E, Tzovaras G. The effect of a diverting ileostomy formation on nutritional status and energy intake of patients undergoing colorectal surgery. Clin Nutr ESPEN. 2020 Dec;40:357-362. doi: 10.1016/j.clnesp.2020.08.002. Epub 2020 Aug 28.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: nutritional status; ileostomy; dehydration; colorectal resection
• Other Study ID Numbers: LarissaUH