A Prediction Model of Anastomotic Stricture After Rectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06404554
• Other study ID #: NorthernJiangsu004
• Status: Completed
• Start date: January 1, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Northern Jiangsu People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1542
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Stenosis
• Colorectal Cancer
• Constriction, Pathologic
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• without any intervention
without any intervention

Locations

Country	Name	City	State
China	Yifan Cheng	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients with anastomotic stricture	Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis	up to six months
Primary	patients without anastomotic stricture	Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis	up to six months