Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273826
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-15
Brief Title:
Colorectal Leakage App for Early Detection of Anastomotic Leakage After Colorectal Surgeries
Sponsor:
National Research Oncology and Transplantology Center Kazakhstan
Organization:
National Research Oncology and Transplantology Center Kazakhstan
Study Overview
Official Title:
The Implementation of the Mobile Application Colorectal Leakage App Based on the Dutch Leakage Score for Early Detection of Anastomotic Leakage After Colorectal Surgeries
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1 Development validation and implementation of the mobile application Colorectal Leakage App based on the Dutch Leakage Score
2 Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries
3 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
Main Questions
1 Development validation and implementation of the mobile application Colorectal Leakage App based on the Dutch Leakage Score
2 Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries
3 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
Detailed Description:
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
1 Design of the study
Prospective observational study where the Colorectal Leakage App mobile application will be implemented in daily postoperative monitoring Additionally an assessment of the diagnostic effectiveness of this application will be conducted
2 Instruments and equipment
The Colorectal Leakage App is a mobile application that based on an algorithm provides an assessment of the risk of Anastomotic Leakage AL in patients after colorectal surgeries The algorithm is built on the standardized postoperative monitoring protocol called Dutch Leakage Score After calculating the scores the application provides recommendations for further actions
Primary endpoints
1 Sensitivity Specificity Positive Predictive Value Negative Predictive Value
2 Frequency of AL after colorectal surgeries
Secondary endpoints
1 Mortality within 30 days
2 Delay in the diagnosis of AL number of days from the onset of the first signs of a leakage to the diagnosis of AL
3 Duration of hospital stay
4 Number of days in the ICU
5 Number of days between surgery and detection of AL
Postoperative monitoring with the Colorectal Leakage App
It is planned to implement standardized postoperative monitoring for patients who have undergone colorectal surgeries using the Colorectal Leakage App The application will include an algorithm based on the Dutch Leakage Score indicator Each postoperative day data entry at the patients bedside will be carried out in the application
1 Fever
2 Heart rate
3 Respiratory rate
4 Urinary production
5 Mental status
6 Clinical condition
7 Signs of ileus
8 Gastric retention
9 Fascial dehiscence
10 Abdominal pain other than
11 wound pain
12 Increased leukocyte count C-reactive protein CRP creatinine and urea
13 Nutritional status Based on the data analysis the algorithm will provide recommendations regarding the necessity of conducting a computer tomography with rectal contrast
The following information will also be collected Preoperative risk factors for ALage gender obesity nutritional status diabetes cardiovascular diseases renal insufficiency inflammatory bowel diseases ASAscore bowel preparation Surgery data access surgery type anastomosis technique duration of surgery blood loss volume formation of a preventive stoma intraoperative and postoperative complications pTNM
Key points determining the conclusion of a patients participation in the study will be the detection of AL patient discharge from the hospital or patient death
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
1 Design of the study
Prospective observational study where the Colorectal Leakage App mobile application will be implemented in daily postoperative monitoring Additionally an assessment of the diagnostic effectiveness of this application will be conducted
2 Instruments and equipment
The Colorectal Leakage App is a mobile application that based on an algorithm provides an assessment of the risk of Anastomotic Leakage AL in patients after colorectal surgeries The algorithm is built on the standardized postoperative monitoring protocol called Dutch Leakage Score After calculating the scores the application provides recommendations for further actions
Primary endpoints
1 Sensitivity Specificity Positive Predictive Value Negative Predictive Value
2 Frequency of AL after colorectal surgeries
Secondary endpoints
1 Mortality within 30 days
2 Delay in the diagnosis of AL number of days from the onset of the first signs of a leakage to the diagnosis of AL
3 Duration of hospital stay
4 Number of days in the ICU
5 Number of days between surgery and detection of AL
Postoperative monitoring with the Colorectal Leakage App
It is planned to implement standardized postoperative monitoring for patients who have undergone colorectal surgeries using the Colorectal Leakage App The application will include an algorithm based on the Dutch Leakage Score indicator Each postoperative day data entry at the patients bedside will be carried out in the application
1 Fever
2 Heart rate
3 Respiratory rate
4 Urinary production
5 Mental status
6 Clinical condition
7 Signs of ileus
8 Gastric retention
9 Fascial dehiscence
10 Abdominal pain other than
11 wound pain
12 Increased leukocyte count C-reactive protein CRP creatinine and urea
13 Nutritional status Based on the data analysis the algorithm will provide recommendations regarding the necessity of conducting a computer tomography with rectal contrast
The following information will also be collected Preoperative risk factors for ALage gender obesity nutritional status diabetes cardiovascular diseases renal insufficiency inflammatory bowel diseases ASAscore bowel preparation Surgery data access surgery type anastomosis technique duration of surgery blood loss volume formation of a preventive stoma intraoperative and postoperative complications pTNM
Key points determining the conclusion of a patients participation in the study will be the detection of AL patient discharge from the hospital or patient death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None