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临床试验/CTRI/2025/01/079731
CTRI/2025/01/079731尚未招募不适用

Impact of implementing co-designed care bundles on the outcomes of critically ill patients after emergency exploratory laparotomy-a pre-post analysis.

Amit Kumar Dey1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
152
试验地点
1
主要终点
To compare perioperative outcomes of the patients undergoing emergency exploratory laparotomy before and after implementing the AIIMS Emergency Laparotomy Quality Improvement Care Bundle (AEL-QICB).

研究概览

简要总结

Emergency exploratory laparotomy is a critical surgical procedure often performed on patients with acute abdominal conditions with an annual incidence of around one in a thousand population. Bowel obstruction and bowel perforation, along with bowel ischemia, account for the majority of the patient population. The incidences and burden of the acute surgical abdomen in India are comparable worldwide.

Given the urgency and complexity of the surgery, emergency laparotomy carries very high mortality and morbidity worldwide. Although the underlying pathology varies pre-operatively, often, the patients are elderly and very sick with sepsis and organ dysfunction. Preparing these patients for high-risk surgery consumes a meaningful amount of hospital resources, although crucial for optimizing outcomes and reducing morbidity and mortality rates. Multinational studies reported a short-term mortality of 7-21%  and an even higher (26.6%) long-term mortality, along with a significant proportion (23.8%) requiring ICU admission.

Exploratory laparotomy patients requiring ICU care have documented considerable morbidity and mortality (33%, 1-year mortality and 59.4%, 5-year mortality) along with higher resource utilization. Independent predictors of mortality were older age(>62), high APACHE-II score, peri-operative immunosuppression, and delayed admission to the ICU.

Several quality improvement initiatives have been implemented worldwide, like the UK Emergency Laparotomy Network (ELN), emergency laparotomy pathway quality improvement care (ELPQuiC), Enhanced Peri-Operative Care for High-risk Patients (EPOCH), ERAS exploratory Laparotomy 2022 etc, with mixed results.  Data on acute care in emergency exploratory laparotomy are lacking in lower-middle-income countries, especially populous countries like India.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Undergoing emergency exploratory (upper and lower midline incision) laparotomy for the acute disease process, trauma, or surgical complication required intensive care in the perioperative period Patients requiring concurrent general thoracotomy are also included.

排除标准

  • Patients under 16 years of age 2)Elective laparotomy 3)Appendicectomy of any type as the sole surgical procedure 4)Cholecystectomy of any type as the sole surgical procedure 5)Gynecological laparoscopy or laparotomy of any type unless the primary pathology is proven to be general surgical 6)Surgery related to organ transplantation 7)Emergency laparotomy for vascular surgery.

结局指标

主要结局

To compare perioperative outcomes of the patients undergoing emergency exploratory laparotomy before and after implementing the AIIMS Emergency Laparotomy Quality Improvement Care Bundle (AEL-QICB).

时间窗: Primary outcome-ICU and in-hospital mortality will be assessed within 30 days of hospitalization.

Primary objective- To compare the ICU and in-hospital mortality between the two study populations.

时间窗: Primary outcome-ICU and in-hospital mortality will be assessed within 30 days of hospitalization.

次要结局

  • Secondary objectives-(Day 30 mortality)

研究者

发起方
Amit Kumar Dey
申办方类型
Other [Amit Kumar Dey]
责任方
Principal Investigator
主要研究者

Amit Kumar Dey

AIIMS Bhubaneswar

研究点 (1)

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