Evaluation of AL Prediction for Rectal Cancer

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Prediction model evaluation

About this trial

This is an interventional prevention trial for Anastomotic Leak Rectum focused on measuring Anastomotic Leak, rectal cancer, machine learning

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18-75 years Adenocarcinoma confirmed by pathology 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 Preoperative imaging diagnosis was cTxNxM0 No 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 anesthesia Voluntarily sign the informed consent form Exclusion Criteria: Previous history of malignant tumor Simultaneous multiple primary colorectal cancer Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery Patients with familial adenomatous polyposis and active inflammatory bowel disease A history of severe mental illness pregnant or lactating women Patients with uncontrolled infection before operation The investigator did not consider the patient to be eligible for the trial

Sites / Locations

Department of Colorectal Surgery in Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Surgeon evaluation

Surgeon combining with model evaluation

Arm Description

Outcomes

Primary Outcome Measures

Accuracy of stoma implementation

Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients.

Secondary Outcome Measures

Sensitivity and specificity in the prediction of anastomotic leakage

Grade C leakage rate

Preventive stoma rate

Rate of stoma reverse

Full Information

NCT ID

NCT05610904

First Posted

October 30, 2022

Last Updated

November 3, 2022

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05610904

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 10, 2022 (Anticipated)

Primary Completion Date

October 10, 2024 (Anticipated)

Study Completion Date

October 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anastomotic Leak Rectum

Keywords

Anastomotic Leak, rectal cancer, machine learning

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgeon evaluation

Arm Type

No Intervention

Arm Title

Surgeon combining with model evaluation

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

Prediction model evaluation

Intervention Description

a machine learning based anastomotic leakage prediction model

Primary Outcome Measure Information:

Title

Accuracy of stoma implementation

Description

Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients.

Time Frame

1 months after surgery

Secondary Outcome Measure Information:

Title

Sensitivity and specificity in the prediction of anastomotic leakage

Time Frame

1 months after surgery

Title

Grade C leakage rate

Time Frame

1 months after surgery

Title

Preventive stoma rate

Time Frame

1 months after surgery

Title

Rate of stoma reverse

Time Frame

3-6 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients aged 18-75 years Adenocarcinoma confirmed by pathology 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 Preoperative imaging diagnosis was cTxNxM0 No 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 anesthesia Voluntarily sign the informed consent form Exclusion Criteria: Previous history of malignant tumor Simultaneous multiple primary colorectal cancer Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery Patients with familial adenomatous polyposis and active inflammatory bowel disease A history of severe mental illness pregnant or lactating women Patients with uncontrolled infection before operation The investigator did not consider the patient to be eligible for the trial

Facility Information:

Facility Name

Department of Colorectal Surgery in Changhai Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Anastomotic Leak Rectum

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial