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临床试验/NCT02036346
NCT02036346已完成不适用

The Effect of Ileostomy Formation on Nutritional Status and Electrolyte Profile in Rectosigmoidectomy Patients: a Prospective Randomized Trial.

Larissa University Hospital2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

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

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

Experimental

Patients who have undergone colorectal resection surgery resulting in an ileostomy creation

干预措施: Oral Ηydration Solution (Dietary Supplement)

No intervention

Experimental

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

Active Comparator

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

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ATHANASIOS MIGDANIS

SRD, M.Sc.

Larissa University Hospital

研究点 (2)

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