Electrolyte Profile, Nutritional Status and Ileostomy Formation.

NCT02036346 | Completed DMC

• 1 other identifier: LarissaUH
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Resection; Ileostomy

Keywords

ileostomy; colorectal resection; dehydration; nutritional status

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Physical findings of dehydration

  20 days postoperatively, 40 days postoperatively

• Biochemical markers reflecting dehydration and renal function

  20 days postoperativey, 40 days postoperatively

• Biochemical markers reflecting dehydration and renal function

  20 days postoperativey, 40 days postoperatively

• Anthropometric characteristics

  baseline, 40 days postoperatively

• Anthropometric characteristics

  baseline, 40 days postoperatively

Study Arms (3)

Oral rehydration solution

EXPERIMENTAL

Patients who have undergone colorectal resection surgery resulting in an ileostomy creation

Dietary Supplement: Oral Ηydration Solution

No intervention

EXPERIMENTAL

Patients who have undergone colorectal resection surgery resulting in an ileostomy creation

Other: Advise on calculated oral fluid requirements

Colorectal resection without an ileostomy

ACTIVE COMPARATOR

Patients who have undergone colorectal resection surgery without an ileostomy creation

Other: No nutritional advice will be given

Interventions

Oral Ηydration Solution DIETARY_SUPPLEMENT

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

Oral rehydration solution

Advise on calculated oral fluid requirements OTHER

No intervention

No nutritional advice will be given OTHER

Colorectal resection without an ileostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Short Bowel Syndrome
• Diabetic ketoacidosis
• Chronic Renal failure
• Hepatic/Cardiac failure
• Diabetes insipidus
• Diuretic Medication
• Corticosteroid Medication

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Thessaly: collaborator

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

Related Publications (2)

• 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.

  PMID: 29771807 BACKGROUND

• 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.

  PMID: 33183563 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GEORGE TZOVARAS, MD

  University Hospital of Larissa

  STUDY CHAIR

• GEORGE TZOVARAS, MD

  University Hopsital of Larissa

  STUDY DIRECTOR

• Georgios D Koukoulis, M.D. MSc PhD

  Department of General Surgery, University Hospital of Larisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SRD, M.Sc.

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 15, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

GR (1)