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?
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
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
Start Date: December 2013
Completed Date: January 2018
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
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.