Feasibility and Safety of an Ileus Management Protocol for Postoperative Ileus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of the I-MAP Algorithm
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a standardized treatment algorithm, the Ileus Management Protocol (I-MAP), is feasible and safe for the management of patients who develop postoperative ileus (POI) within 30 days after abdominal surgery.
The main questions it aims to answer are:
Can I-MAP be applied consistently, with ≥85% adherence, in eligible patients with POI?
Is the use of I-MAP associated with acceptable safety outcomes, including low rates of complications such as pneumonia, aspiration, and adverse events?
This study does not include a comparison group. All participants are assigned to the I-MAP protocol, and outcomes are evaluated prospectively.
Participants will:
Be monitored for POI symptoms (nausea, vomiting, bloating, absence of gas/stool).
Receive standardized management according to I-MAP, which includes:
Daily assessment of nasogastric tube (NGT) output.
Water-soluble contrast administration via NGT when indicated.
Imaging (CT scan or X-ray) if obstruction is suspected.
Neostigmine administration if small bowel obstruction is excluded.
The primary endpoint is the feasibility of I-MAP, defined as the proportion of POI patients treated according to the algorithm. Secondary outcomes include NGT reinsertion, duration of NGT placement, hospital length of stay, conservative treatment failure, and complications related to POI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adults ≥18 years of age.
- •Patients who undergo abdominal surgery and develop postoperative ileus (POI) within 30 days.
- •Provided general consent for participation.
排除标准
- •Preoperative bowel obstruction.
- •Anastomotic leak.
- •Prophylactic nasogastric tube (NGT) placement.
- •Pregnancy.
- •Lack of general consent.
结局指标
主要结局
Feasibility of the I-MAP Algorithm
时间窗: From surgery until resolution of postoperative ileus (up to 30 days).
Proportion of eligible patients with postoperative ileus who are managed according to the standardized Ileus Management Protocol (I-MAP). A protocol adherence rate of ≥85% is considered indicative of feasibility.
次要结局
- Nasogastric Tube (NGT) Reinsertion(From surgery until resolution of postoperative ileus (up to 30 days).)
- Duration of Nasogastric Tube Placement(From initial placement until final removal, during index hospital stay, up to 30 days.)
- Hospital Length of Stay (LOS)(From day of surgery until discharge, up to 30 days.)
- Postoperative Ileus-Related Complications(From initiation of conservative treatment until resolution of ileus, up to 30 days after surgery.)
- Conservative Treatment Failure(From initiation of conservative treatment until resolution of ileus or re-intervention, up to 30 days after surgery.)
研究者
David Fuks
Professor, Head of the Department of Visceral surgery
University of Lausanne Hospitals