Bowel surgery influences body's water, electrolyte and sugar control

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
INTERVENTION: Part 1 (Observational study) Experimental design: To measure indices of sodium intake (diet diary), sodium loss (urine Na+, K+, plasma aldosterone) and insulin resistance (insulin, glucose, adiponectin, fasting lipids and blood pressure) in a large cohort of patients. Methods: 50 IRA, 25 RPC and 25 colectomy with ileostomy patients will be recruited. Patients will attend one clinical investigation day. As part of the clinical investigation day, participant's blood samples will be collected in the outpatient clinic after an overnight fast (12 hours of fasting). Participant will be allowed to drink water, but will be asked to avoid sugary drinks. The participant will also provide a urine sample to be tested. The participant's blood pressure, body weight, height and test of muscle strength will be recorded non‐invasively. The participant will be instructed to complete a 7 day food record for the assessment of both salt, energy and nutrient intakes prior to attending the clinical investigation day. Quality of life, or self‐reported health status will also be assessed using the SF‐36 and FACIT (F)?version‐4 questionnaires and compared to reference values from the general population. Part 2 Experimental design: To perform a single‐blind, placebo‐controlled randomised cross‐over trial of the effects of rehydration on the hyperaldosteronism and abnormal glucose tolerance in patients after IRA or RPC or colectomy with ileostomy. Methods: 30 patients with demonstrated hyperaldosteronism from part 1 will be recruited. Arm A: 15 patients will receive the 'placebo' drink for 4 weeks. Patients will then attend a clinical investigation day as for part 1 of the study. Patients will then have a 4‐week washout period following which they will attend St Mark's Hospital for their second clinical investigation day. Patients will be provided with the active rehydration drink sachets (1 sachet in 1 litre of water to be consumed 1 tumbler with meals everyday). Patients will be advi CONDITION: Metabolic disturbances following colectomy ; Surgery PRIMARY OUTCOME: To determine how prevalent sodium depletion and hyperaldosteronism are in well adapted patients following ileorectal anastomosis (IRA) or restorative proctocolectomy (RPC) or colectomy with ileostomy. SECONDARY OUTCOME: 1. To determine if sodium depletion in well adapted patients following IRA or RPC or colectomy with ileostomy is associated with and causative of abnormal glucose tolerance.; 2. To ascertain if these metabolic changes can be reversed with a simple rehydration therapy which could be easily incorporated into patient aftercare.; 3. To ascertain if these metabolic changes can be prevented from developing post‐operatively with a simple rehydration therapy which could be easily incorporated; 4. Differences in health‐related quality of life scores as assessed using SF‐36 and FACIT‐ F questionnaires INCLUSION CRITERIA: 1. Participants who have undergone IRA or RPC or colectomy with ileostomy 2. Surgery >1 year previously, or preoperative patients (part 3) 3. Absence of small bowel disease, Crohn's, Coeliac disease etc 4. No recent use of steroid medication (< 1 year) 5. 18 < BMI < 30 kg/m2 6. Minimal small bowel resection (<10 cm) 7. Aged 14‐70 years
Epistemonikos ID: bbad51cf804934bd8c6d9259e6172a19cf02cc64
First added on: Aug 22, 2024