NCT07267767

Brief Summary

Following thorough screening based on inclusion and exclusion criteria, patients from the two sizable medical centers were split up into two cohorts for this study. Cohort 1 served primarily as the training and internal validation set, while Cohort 2 was used for external validation of the predictive model constructed from Cohort 1. We used six distinct machine learning methodss, including DT, RF, XGBOOST, SVM, lightGBM, and SHLNN, in addition to conventional logistic regression to create the predictive model. We chose the approach with the best sensitivity and specificity by comparing the concordance index(C-index) akin to the area under the ROC curve (AUC) of these seven distinct model-building methods. The predictive model for Cohort 1 was then built using this method, and internal validation was finished. Lastly, Cohort 2 underwent external validation of the predictive model

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

8.5 years

First QC Date

July 9, 2025

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • low anterior resection syndrome

    1 and 3 months after surgery

  • Comparison of Six Different Machine Learning Methods With Traditional Model for Low Anterior Resection Syndrome After Minimally Invasive Surgery for Rectal Cancer -- Development and External Validation of a Nomogram : A Dual-center Cohort Study

    using LARS Score to assess the LARS situation

    3 months

Interventions

BMIBEHAVIORAL

Body Mass Index

Surgical typePROCEDURE

laparoscopic and robotic surgery

tatme + isr

LCA Preserving

nCRTPROCEDURE

neoadjuvant chemoradiotherapy

Distance from AVDIAGNOSTIC_TEST

Distance from AV

Prophylactic stoma

Anastomotic leakage

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This retrospective analysis included 3,937 radical rectal cancer cases from two Chinese university hospitals (Northern Jiangsu People's Hospital 2015-2023, n=2612; Jilin University's China-Japan Union Hospital 2021-2023, n=1325), with rigorous selection criteria ensuring cohort homogeneity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal NeoplasmsLow Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
15 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NANJING UNIVERSITY

Study Record Dates

First Submitted

July 9, 2025

First Posted

December 5, 2025

Study Start

April 10, 2015

Primary Completion

October 7, 2023

Study Completion

June 20, 2024

Last Updated

December 5, 2025

Record last verified: 2025-11