Evaluation of AL Prediction for Rectal Cancer

Naval Military Medical University

Status: Not yet enrolling

Conditions: Anastomotic Leak Rectum

Treatments: Diagnostic Test: Prediction model evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05610904

CHALP001

Details and patient eligibility

About

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.

Enrollment: 418 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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418 participants in 2 patient groups

Surgeon evaluation

No Intervention group

Surgeon combining with model evaluation

Experimental group

Treatment:

Diagnostic Test: Prediction model evaluation