The Implementation of the Mobile Application "Colorectal Leakage App", Based on the Dutch Leakage Score, for Early Detection of Anastomotic Leakage After Colorectal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Frequency of anastomotic leakage after colorectal surgeries.
研究概览
简要总结
The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.
Main Questions:
- Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.
- Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.
- Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.
Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage.
详细描述
Colorectal cancer ranks third among oncological diseases in Kazakhstan, both in men and women. Anastomotic leakage (AL) following colorectal surgeries is one of the most serious complications arising from colorectal surgical interventions. This condition is characterized by increased mortality and significant deterioration in the quality of life of patients. Additionally, the presence of AL after anterior resections for rectal cancer is associated with an increased risk of local disease recurrence. The frequency of AL varies between 2 and 19%, depending on risk factors, AL definition, and the level of anastomosis. Given the high likelihood and severe consequences of AL, a relevant task is its early detection and effective treatment.
Clinical signs of AL traditionally include fever, tachycardia, pain syndrome, purulent or fecal discharge through drainage, and dynamic bowel obstruction. These signs, combined with other clinical data, are integrated into a diagnostic-specific indicator known as the Dutch Leakage Score (DLS). This indicator is used as a standardized postoperative monitoring protocol for patients suspected of having AL, aiming to minimize delays in detecting this complication and, consequently, reduce early postoperative mortality.
In this prospective observational study, we aim to assess the effectiveness of the mobile application "Colorectal Leakage App" in the early detection of anastomotic leakage (AL) after colorectal surgeries. The study will be conducted at the National Research Oncology Center (NROC) in Astana, Kazakhstan, over one year. The primary goal is to evaluate the diagnostic effectiveness of the application in detecting AL after colorectal surgeries.
It is important to note that there is currently no up-to-date data on the number of colorectal cancer surgeries performed, and information on the frequency of AL after colorectal surgeries in the population of Kazakhstan is also lacking. Previous studies have shown that the effectiveness of the DLS algorithm is directly proportional to the frequency of AL. Therefore, it is assumed that the application of DLS may demonstrate different results in the conditions of Kazakhstan, which we also plan to measure through the "Colorectal Leakage App" mobile application.
- Design of the study:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Scheduled patients with benign and malignant colorectal diseases undergoing surgical treatment, including the creation of anastomoses (ileocolic, colocolic, colorectal anastomoses), with or without a preventive stoma.
- •Male and female patients aged 18 years and older.
- •ECOG = 0-2;
- •Satisfactory hematological indicators and parameters of liver and kidney function.
排除标准
- •Participants under 18 years old.
- •Pregnant, lactating, or planning pregnancy participants.
- •Unresctable tumors.
- •Patient's refusal to continue participating in the study..
结局指标
主要结局
Frequency of anastomotic leakage after colorectal surgeries.
时间窗: 1 year
Measurement of frequency of anastomotic leakage after colorectal surgeries at the National Research Oncology Center (NROC) in Astana, Kazakhstan.
Diagnostic effectiveness of "Colorectal Leakage App".
时间窗: 1 year
Measurement of sensitivity, specificity, positive predictive value and negative predictive value of the mobile application "Colorectal Leakage App".
次要结局
- Number of days in the ICU.(1 year)
- Mortality within 30 days(1 year)
- Delay in the diagnosis of anastomotic leakage(1 year)
- Number of days between surgery and detection of AL.(1 year)
- Duration of hospital stay.(1 year)
研究者
Meiram Mamlin, MD
Head of the colorectal division.
National Research Oncology and Transplantology Center, Kazakhstan