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Trial Title:
Evaluation of AL Prediction for Rectal Cancer
NCT ID:
NCT05610904
Condition:
Anastomotic Leak Rectum
Conditions: Official terms:
Rectal Neoplasms
Anastomotic Leak
Conditions: Keywords:
Anastomotic Leak
rectal cancer
machine learning
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Prediction model evaluation
Description:
a machine learning based anastomotic leakage prediction model
Arm group label:
Surgeon combining with model evaluation
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Colorectal Surgery in Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Start date:
December 10, 2022
Completion date:
October 10, 2025
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05610904
