Clinical trial NCT05610904: Evaluation of AL Prediction for Rectal Cancer
Official title: Evaluation of a Machine Learning Based Anastomotic Leakage Prediction Model After Anterior Resection for Rectal cancer-a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anastomotic Leak Rectum
Keywords: Anastomotic Leak
rectal cancer
machine learning
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of stoma implementation
timeFrame: 1 months after surgery
Secondary outcomes:
measure: Sensitivity and specificity in the prediction of anastomotic leakage
timeFrame: 1 months after surgery
measure: Grade C leakage rate
timeFrame: 1 months after surgery
measure: Preventive stoma rate
timeFrame: 1 months after surgery
measure: Rate of stoma reverse
timeFrame: 3-6 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Colorectal Surgery in Changhai Hospital
state: Shanghai
Study officials:
References: