Electrolyte Profile, Nutritional Status and Ileostomy Formation.

NCT02036346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2018-07-03

No results posted yet for this study

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.

Conditions

  • Colorectal Resection
  • Ileostomy

Interventions

DIETARY_SUPPLEMENT

Oral Ηydration Solution

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

OTHER

Advise on calculated oral fluid requirements

OTHER

No nutritional advice will be given

Sponsors & Collaborators

  • University of Thessaly

    collaborator OTHER
  • Larissa University Hospital

    lead OTHER

Principal Investigators

  • GEORGE TZOVARAS, MD · University Hospital of Larissa

  • GEORGE TZOVARAS, MD · University Hopsital of Larissa

  • Georgios D Koukoulis, M.D. MSc PhD · Department of General Surgery, University Hospital of Larisa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02036346 on ClinicalTrials.gov