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NCT05610904
Evaluation of AL Prediction for Rectal Cancer
Conditions: Anastomotic Leak Rectum
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 418
Sponsor: Changhai Hospital
Location: China
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:Patients aged 18-75 yearsAdenocarcinoma confirmed by pathologyColonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal edge was less than or equal to 12cmPreoperative imaging diagnosis was cTxNxM0No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, and no invasion of adjacent organs)The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesiaVoluntarily sign the informed consent formExclusion Criteria:Previous history of malignant tumorSimultaneous multiple primary colorectal cancerPrevious multiple abdominal and pelvic surgeries or extensive abdominal adhesionsPatients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgeryPatients with familial adenomatous polyposis and active inflammatory bowel diseaseA history of severe mental illnesspregnant or lactating womenPatients with uncontrolled infection before operationThe investigator did not consider the patient to be eligible for the trial
Source: ClinicalTrials.gov (NCT05610904). StuddyBuddy aggregates publicly available trial information.