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Completed

NCT Number: NCT02036346

Electrolyte Profile, Nutritional Status and Ileostomy Formation.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Ηydration Solution

Dietary Supplement

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

Advise on calculated oral fluid requirements

Other

No nutritional advice will be given

Other

Primary outcomes

  1. Serum electrolyte levels

    Time frame: up to 20-40 days postoperatively

    sodium (mmol/l)

  2. Serum electrolyte levels

    Time frame: up to 20-40 days postoperatively

    potassium (mmol/l)

  3. Serum electrolyte levels

    Time frame: up to 20-40 days postoperatively

    magnesium (mg/dl)

  4. Serum electrolyte levels

    Time frame: up to 20-40 days postoperatively

    chloride (mmol/l)

Secondary outcomes

  1. Physical findings of dehydration

    Time frame: 20 days postoperatively, 40 days postoperatively

    thirst, dizziness, lethargy, oliguria, dense urine

  2. Biochemical markers reflecting dehydration and renal function

    Time frame: 20 days postoperativey, 40 days postoperatively

    Urea (mg/dl)

  3. Biochemical markers reflecting dehydration and renal function

    Time frame: 20 days postoperativey, 40 days postoperatively

    Creatinine (mg/dl)

  4. Anthropometric characteristics

    Time frame: baseline, 40 days postoperatively

    weight (kg)

  5. Anthropometric characteristics

    Time frame: baseline, 40 days postoperatively

    height (m)

  6. Anthropometric characteristics

    Time frame: baseline, 40 days postoperatively

    BMI (kg/m2)

  7. Anthropometric characteristics

    Time frame: baseline, 40 days postoperatively

    total body fat (%)

  8. Nutritional Intake

    Time frame: baseline, at 20 days and 40 days postoperatively

    Energy intake assessed through 24hour recalls and analyzed via nutrition analysis software

  9. Nutritional Intake

    Time frame: baseline, at 20 days and 40 days postoperatively

    Macronutrient intake assessed through 24hour recalls and analyzed via nutrition analysis software

  10. Nutritional Intake

    Time frame: baseline, at 20 days and 40 days postoperatively

    Electrolyte intake via diet assessed through 24hour recalls and analyzed via nutrition analysis software

  11. Stoma output (ml/L)

    Time frame: baseline, at 20 days and 40 days postoperatively

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Collaborators

  • University of Thessaly

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jan 15, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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