Anastomotic Leak Rectum
Conditions
Keywords
Anastomotic Leak, rectal cancer, machine learning
Brief summary
Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.
Interventions
DIAGNOSTIC_TESTPrediction model evaluation
a machine learning based anastomotic leakage prediction model
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18-75 years 2. Adenocarcinoma confirmed by pathology 3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal edge was less than or equal to 12cm 4. Preoperative imaging diagnosis was cTxNxM0 5. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, and no invasion of adjacent organs) 6. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia 7. Voluntarily sign the informed consent form
Exclusion criteria
1. Previous history of malignant tumor 2. Simultaneous multiple primary colorectal cancer 3. Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions 4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery 5. Patients with familial adenomatous polyposis and active inflammatory bowel disease 6. A history of severe mental illness 7. pregnant or lactating women 8. Patients with uncontrolled infection before operation 9. The investigator did not consider the patient to be eligible for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of stoma implementation | 1 months after surgery | Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients. |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity in the prediction of anastomotic leakage | 1 months after surgery |
| Grade C leakage rate | 1 months after surgery |
| Preventive stoma rate | 1 months after surgery |
| Rate of stoma reverse | 3-6 months after surgery |
Countries
China
Outcome results
None listed