A Prediction Model of Anastomotic Stricture After Rectal Cancer

NCT ID: NCT06404554

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1542 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-04-30

Brief Summary

Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.

Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.

Conditions

Colorectal Cancer; Rectal Cancer; Anastomotic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients with anastomotic stricture

without any intervention, patients diagnose as anastomotic stricture after rectal cancer surgery

without any intervention

Intervention Type: OTHER

without any intervention

patients without anastomotic stricture

without any intervention, patients does not diagnose as anastomotic stricture after rectal cancer surgery

without any intervention

Intervention Type: OTHER

without any intervention

Interventions

without any intervention

without any intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. pathological confirmation of rectal cancer;

2. eligibility for surgical intervention;

3. undergoing first rectal cancer surgery;

4. acquisition of written informed consent from patients and their families;

5. no history of hypertrophic scar or allergic predispositions.

Exclusion Criteria

1. absence of postoperative follow-up or anastomosis details;

2. patients subjected to Hartmann or Miles procedures;

3. emergency surgery candidates due to conditions like perforation or obstruction;

4. diagnosis of multiple primary malignancies;

5. intraoperative discovery of widespread implant metastases within the abdominal cavity;

6. severe comorbidities;

7. anastomotic recurrence of rectal cancer;

8. patients who had undergone stapled hemorrhoidopexy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daorong Wang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yifan Cheng

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

NorthernJiangsu004

Identifier Type: -

Identifier Source: org_study_id