Mobile app for early detection of leaks after colorectal surgery
The Implementation of the Mobile Application "Colorectal Leakage App", Based on the Dutch Leakage Score, for Early Detection of Anastomotic Leakage After Colorectal Surgeries
This study is testing a mobile app that helps doctors spot leaks after colorectal surgery to see if it can improve recovery for patients aged 18 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Research Oncology and Transplantology Center, Kazakhstan Academic / other |
| Locations | 1 site (Astana) |
| Trial ID | NCT06273826 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the 'Colorectal Leakage App' in diagnosing anastomotic leakage after colorectal surgeries. Participants aged 18 and older undergoing such surgeries will be monitored using the app during their postoperative period. The app utilizes the Dutch Leakage Score to identify potential complications early, aiming to improve patient outcomes and reduce mortality associated with anastomotic leakage. The study is conducted at the National Research Oncology Center in Astana, Kazakhstan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for colorectal surgeries involving anastomoses.
Not a fit: Patients under 18, those with unresctable tumors, or those with an ECOG performance status greater than 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could significantly enhance early detection of anastomotic leakage, leading to improved patient outcomes and reduced complications.
How similar studies have performed: While the use of mobile applications for monitoring postoperative complications is emerging, this specific approach using the Dutch Leakage Score is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Male and female patients aged 18 years and older. 3. ECOG = 0-2; 6. Satisfactory hematological indicators and parameters of liver and kidney function. Exclusion Criteria: 1. Participants under 18 years old. 2. Pregnant, lactating, or planning pregnancy participants. 3. ECOG\>2; 4. Unresctable tumors. 5. Patient's refusal to continue participating in the study..
Where this trial is running
Astana
- National Research Oncology Center — Astana, Kazakhstan (Recruiting)
Study contacts
- Principal investigator: Meiram Mamlin, MD — National Research Oncology Center
- Study coordinator: Saule Khamzina, MD
- Email: khamzina.saule88@gmail.com
- Phone: +77757172961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.