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Early Versus Delayed Ileostomy Closure Following Bowel Surgery (EDIC)

2026年8月24日 更新者:Dr. Waseem Ullah

Comparison of Mean Post-Operative Hospital Stay in Early and Delayed Ileostomy Closure Following Bowel Surgery: A Randomized Controlled Trial

Temporary ileostomy is commonly created following bowel surgery to protect distal anastomoses and reduce the consequences of anastomotic leakage. However, the optimal timing for ileostomy closure remains controversial. Early closure may improve quality of life and reduce stoma-related complications, whereas delayed closure may allow better recovery but prolong stoma-related morbidity and hospital care. This randomized controlled trial aims to compare the mean post-operative hospital stay between early (within 8 weeks) and delayed (after 8 weeks) ileostomy closure following bowel surgery. Sixty eligible patients will be randomized equally into two groups. The findings will help determine the optimal timing of ileostomy reversal and may improve patient outcomes while reducing healthcare utilization.

研究概览

详细说明

Temporary ileostomy is frequently performed after bowel surgery as a protective measure for intestinal anastomosis or as part of emergency surgical management. Although ileostomy closure is considered a routine procedure, the ideal timing of closure remains uncertain. Early closure has the potential to improve patient quality of life, reduce stoma-related complications, and shorten the overall treatment course. Conversely, delayed closure may provide additional time for recovery and anastomotic healing but may increase the duration of stoma-related morbidity and healthcare resource utilization.

This prospective, randomized controlled trial will be conducted in the Department of General Surgery, Lady Reading Hospital-Medical Teaching Institution, Peshawar, Pakistan. A total of 60 adult patients (18-65 years) with temporary ileostomy following bowel surgery who meet the eligibility criteria will be enrolled using consecutive sampling and randomized in a 1:1 ratio into two study groups using block randomization.

Participants in the intervention group will undergo early ileostomy closure within 8 weeks of ileostomy creation, while participants in the comparator group will undergo delayed ileostomy closure after 8 weeks. The primary outcome will be post-operative hospital stay, measured as the number of days from ileostomy closure surgery until hospital discharge.

Baseline demographic and clinical characteristics, including age, sex, body mass index, smoking status, hypertension, diabetes mellitus, residence, financial background, and post-operative complications, will be recorded. Data will be analyzed using IBM SPSS version 25. Continuous variables will be analyzed using the independent-samples t-test or Mann-Whitney U test according to data distribution, with statistical significance set at p < 0.05.

The study has received ethical approval from the Institutional Review Board of Lady Reading Hospital-Medical Teaching Institution, Peshawar (IRB Reference No. 85/LRH/MTI, dated 06 February 2025). The results are expected to provide evidence regarding the optimal timing of temporary ileostomy closure in terms of reducing post-operative hospital stay and improving clinical outcomes.

研究类型

介入性

注册 (实际的)

73

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Peshawar、巴基斯坦、25000
        • Lady Reading Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria

  • Adults aged 18-65 years.
  • Male or female participants.
  • Patients with a temporary ileostomy following bowel surgery.
  • Patients scheduled for elective ileostomy closure.
  • Participants willing to provide written informed consent.

Exclusion Criteria

  • Abdominal wall dehiscence.
  • Tubercular perforation.
  • Peritoneal contamination.
  • Patients medically unfit for surgery.
  • Refusal to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Early Ileostomy Closure
Participants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery.
Surgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation.
有源比较器:Delayed Ileostomy Closure
Participants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery.
Surgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Post-operative hospital stay
大体时间:From the date of ileostomy closure until hospital discharge (up to 30 days).
Post-operative hospital stay will be measured as the number of days from ileostomy closure surgery until discharge from the hospital. The mean duration will be compared between patients undergoing early (≤8 weeks) and delayed (>8 weeks) ileostomy closure.
From the date of ileostomy closure until hospital discharge (up to 30 days).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月2日

初级完成 (实际的)

2026年7月5日

研究完成 (实际的)

2026年7月8日

研究注册日期

首次提交

2026年8月4日

首先提交符合 QC 标准的

2026年8月4日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LRH-85-2025-ILEO
  • IRB Ref. No. 85/LRH/MTI (06-Fe (其他标识符:Lady Reading Hospital)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

De-identified individual participant data underlying the published results will be available upon reasonable request.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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