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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036346
Enrollment
117
Registered
2014-01-15
Start date
2013-12-31
Completion date
2018-01-31
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Resection, Ileostomy

Keywords

ileostomy, colorectal resection, dehydration, nutritional status

Brief 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.

Interventions

DIETARY_SUPPLEMENTOral Ηydration Solution

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

OTHERAdvise on calculated oral fluid requirements
OTHERNo nutritional advice will be given

Sponsors

University of Thessaly
CollaboratorOTHER
Larissa University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum electrolyte levelsup to 20-40 days postoperativelysodium (mmol/l)

Secondary

MeasureTime frameDescription
Physical findings of dehydration20 days postoperatively, 40 days postoperativelythirst, dizziness, lethargy, oliguria, dense urine
Biochemical markers reflecting dehydration and renal function20 days postoperativey, 40 days postoperativelyUrea (mg/dl)
Anthropometric characteristicsbaseline, 40 days postoperativelyweight (kg)
Nutritional Intakebaseline, at 20 days and 40 days postoperativelyEnergy intake assessed through 24hour recalls and analyzed via nutrition analysis software
Stoma output (ml/L)baseline, at 20 days and 40 days postoperatively

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026