Clinical trial NCT02036346: Electrolyte Profile, Nutritional Status and Ileostomy Formation.
Official title: The Effect of Ileostomy Formation on Nutritional Status and Electrolyte Profile in Rectosigmoidectomy Patients: a Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Resection
Ileostomy
Keywords: ileostomy
colorectal resection
dehydration
nutritional status
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2014-01-15
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum electrolyte levels
timeFrame: up to 20-40 days postoperatively
measure: Serum electrolyte levels
timeFrame: up to 20-40 days postoperatively
measure: Serum electrolyte levels
timeFrame: up to 20-40 days postoperatively
measure: Serum electrolyte levels
timeFrame: up to 20-40 days postoperatively
Secondary outcomes:
measure: Physical findings of dehydration
timeFrame: 20 days postoperatively, 40 days postoperatively
measure: Biochemical markers reflecting dehydration and renal function
timeFrame: 20 days postoperativey, 40 days postoperatively
measure: Biochemical markers reflecting dehydration and renal function
timeFrame: 20 days postoperativey, 40 days postoperatively
measure: Anthropometric characteristics
timeFrame: baseline, 40 days postoperatively
measure: Anthropometric characteristics
timeFrame: baseline, 40 days postoperatively
measure: Anthropometric characteristics
timeFrame: baseline, 40 days postoperatively
measure: Anthropometric characteristics
timeFrame: baseline, 40 days postoperatively
measure: Nutritional Intake
timeFrame: baseline, at 20 days and 40 days postoperatively
measure: Nutritional Intake
timeFrame: baseline, at 20 days and 40 days postoperatively
measure: Nutritional Intake
timeFrame: baseline, at 20 days and 40 days postoperatively
measure: Stoma output (ml/L)
timeFrame: baseline, at 20 days and 40 days postoperatively
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
affiliation: University Hospital of Larissa
name: GEORGE TZOVARAS, MD
role: STUDY_CHAIR
affiliation: University Hopsital of Larissa
name: GEORGE TZOVARAS, MD
role: STUDY_DIRECTOR
affiliation: Department of General Surgery, University Hospital of Larisa
name: Georgios D Koukoulis, M.D. MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.