Evaluation of AL Prediction for Rectal Cancer | NCT05610904

Studies
Evaluation of AL Prediction for Rectal Cancer

NCT05610904

Sponsor

Changhai Hospital

Status

Unknown status

Last Update Posted

Nov 9, 2022Actual

Enrollment

418Estimated

Phase

Not Applicable

Conditions

Anastomotic Leak Rectum

Interventions

Prediction model evaluation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2022Estimated

Primary Completion Date

Oct 10, 2024Estimated

Completion Date

Oct 10, 2025Estimated

First Submitted Date

Oct 30, 2022

First Submission Date that Met QC Criteria

Nov 3, 2022

First Posted Date

Nov 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2022

Last Update Posted Date

Nov 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

418Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgeon evaluation	No Intervention
Surgeon combining with model evaluation	Experimental		Diagnostic Test: Prediction model evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prediction model evaluation	Diagnostic Test	a machine learning based anastomotic leakage prediction model	Surgeon combining with model evaluation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity in the prediction of anastomotic leakage		1 months after surgery
Grade C leakage rate		1 months after surgery
Preventive stoma rate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Department of Colorectal Surgery in Changhai Hospital		Shanghai	Shanghai Municipality	200433	China

Condition Browse Module

MeSH Terms

ID	Term
D057868	Anastomotic Leak
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D015179	Colorectal Neoplasms

Browse Leaves

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Browse Branches

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