Evaluation of AL Prediction for Rectal Cancer

NCT ID: NCT05610904

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-10
• Study Completion Date: 2025-10-10

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.

Conditions

Anastomotic Leak Rectum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Surgeon evaluation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgeon combining with model evaluation

Group Type: EXPERIMENTAL

Prediction model evaluation

Intervention Type: DIAGNOSTIC_TEST

a machine learning based anastomotic leakage prediction model

Interventions

Prediction model evaluation

a machine learning based anastomotic leakage prediction model

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Colorectal Surgery in Changhai Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CHALP001

Identifier Type: -

Identifier Source: org_study_id