"Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries (NCT06273826) | Clinical Trial Compass
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"Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries
Kazakhstan120 participantsStarted 2024-01-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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; 6. Satisfactory hematological indicators and parameters of liver and kidney function.
Exclusion criteria
. Participants under 18 years old.
. Pregnant, lactating, or planning pregnancy participants.
. ECOG\>2;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic effectiveness of "Colorectal Leakage App".
Timeframe: 1 year
2
Frequency of anastomotic leakage after colorectal surgeries.
Timeframe: 1 year
Trial details
NCT IDNCT06273826
SponsorNational Research Oncology and Transplantology Center, Kazakhstan