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临床试验/CTRI/2024/06/069450
CTRI/2024/06/069450尚未招募3 期

Prophylactic use oral rehydration solution to prevent high stoma output after ileostomy A Randomised Controlled Trial

Rajeevan Philip Sridhar1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
256
试验地点
1
主要终点
Incidence of high output stoma

研究概览

简要总结

An ileostomy is a common surgical procedure after major colorectal resections. This is done in patients who are unsuitable for anastomosis or as a covering procedure to protect a fragile anastomosis. One of the most common complications of ileostomy is a high stoma output. High-output stoma can lead to dehydration, electrolyte imbalance, renal impairment and readmission. Oral rehydration solution (ORS) is widely used to treat dehydration and high stoma output.

In our study, we look at the prophylactic use of ORS solution administration to prevent high output stoma and its complications in patients with an ileostomy creation. All consenting patients who have an ileostomy created will be included. Patients will be

randomised into two groups postoperatively in the postoperative period. One group of patients will receive 1 litre of prophylactic ORS solution per day, in addition to a normal diet, in the immediate postoperative period for 4 weeks, and the other group will receive routine care. Incidence of high output stoma, dehydration, electrolyte imbalance and readmission will be recorded in both groups. Patients will be contacted at 2, 3 and 4 weeks (in person or telephonic), and blood tests will be done at week 3. Both groups will be followed up for 4 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All consecutive patients who have an ileostomy creation operation for any indication.
  • All who provide written consent to take part in the study will be included.

排除标准

  • Patients with renal failure, heart failure, jejunostomy and history of previous small bowel resection.

结局指标

主要结局

Incidence of high output stoma

时间窗: 4 weeks

次要结局

  • Prevalence of dehydration symptoms(4 weeks)
  • Incidence of electrolyte imbalance(3 weeks)
  • Incidence of renal impairment(3 weeks)
  • Readmission rate(4 weeks)
  • Time taken for resolution if patient develops high output stoma(4 weeks)

研究者

发起方
Rajeevan Philip Sridhar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rajeevan Philip Sridhar

Christian Medical College, Vellore

研究点 (1)

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