The Effect of Ileostomy Formation on Nutritional Status and Electrolyte Profile in Rectosigmoidectomy Patients: a Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Serum electrolyte levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Short Bowel Syndrome
- •Diabetic ketoacidosis
- •Chronic Renal failure
- •Hepatic/Cardiac failure
- •Diabetes insipidus
- •Diuretic Medication
- •Corticosteroid Medication
研究组 & 干预措施
Oral rehydration solution
Patients who have undergone colorectal resection surgery resulting in an ileostomy creation
干预措施: Oral Ηydration Solution (Dietary Supplement)
No intervention
Patients who have undergone colorectal resection surgery resulting in an ileostomy creation
干预措施: Advise on calculated oral fluid requirements (Other)
Colorectal resection without an ileostomy
Patients who have undergone colorectal resection surgery without an ileostomy creation
干预措施: No nutritional advice will be given (Other)
结局指标
主要结局
Serum electrolyte levels
时间窗: up to 20-40 days postoperatively
sodium (mmol/l)
次要结局
- Physical findings of dehydration(20 days postoperatively, 40 days postoperatively)
- Stoma output (ml/L)(baseline, at 20 days and 40 days postoperatively)
- Biochemical markers reflecting dehydration and renal function(20 days postoperativey, 40 days postoperatively)
- Anthropometric characteristics(baseline, 40 days postoperatively)
- Nutritional Intake(baseline, at 20 days and 40 days postoperatively)
研究者
ATHANASIOS MIGDANIS
SRD, M.Sc.
Larissa University Hospital
