Evaluation of AL Prediction for Rectal Cancer

Last updated: November 3, 2022
Sponsor: Changhai Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rectal Cancer

Digestive System Neoplasms

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT05610904
CHALP001
  • Ages 18-75
  • All Genders

Study 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

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 edgeof 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 activebleeding, no perforation, abscess formation, and no invasion of adjacent organs)
  6. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet therequirements of surgery and anesthesia
  7. Voluntarily sign the informed consent form

Exclusion

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

Study Design

Total Participants: 418
Study Start date:
December 10, 2022
Estimated Completion Date:
October 10, 2025

Connect with a study center

  • Department of Colorectal Surgery in Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

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