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Colorectal Resection | Electrolyte Profile, Nutritional Status and Ileostomy Formation.

Colorectal Resection research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Colorectal Resection

Ileostomy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Oral Ηydration SolutionOral 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Oral rehydration solutionPatients who have undergone colorectal resection surgery resulting in an ileostomy creation

No interventionPatients who have undergone colorectal resection surgery resulting in an ileostomy creation

Colorectal resection without an ileostomyPatients who have undergone colorectal resection surgery without an ileostomy creation

Study Status

Completed

Start Date: December 2013

Completed Date: January 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Serum electrolyte levels

Secondary Outcome: Physical findings of dehydration

Study sponsors, principal investigator, and references

Principal Investigator: GEORGE TZOVARAS, MD

Lead Sponsor: Larissa University Hospital

Collaborator: University of Thessaly

More information:https://clinicaltrials.gov/show/NCT02036346

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.

Discuss Dehydration