A Prediction Model of Anastomotic Stricture After Rectal Cancer

NCT06404554 | Completed

• 1 other identifier: NorthernJiangsu004
• Study Type: observational
• Target: 1,542
• Locations: 1 country
• Sites: 1

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

Keywords

nomogram; rectal cancer; anastomotic stricture

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

patients with anastomotic stricture

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

Other: without any intervention

patients without anastomotic stricture

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

Other: without any intervention

Interventions

without any intervention OTHER

without any intervention

patients with anastomotic stricture; patients without anastomotic stricture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who underwent anterior resection for rectal cancer at the Department of Gastrointestinal Surgery, Northern Jiangsu People's Hospital. All participants received radical treatment consistent with total mesorectal excision (TME) principles

You may qualify if:

• pathological confirmation of rectal cancer;
• eligibility for surgical intervention;
• undergoing first rectal cancer surgery;
• acquisition of written informed consent from patients and their families;
• no history of hypertrophic scar or allergic predispositions.

You may not qualify if:

• absence of postoperative follow-up or anastomosis details;
• patients subjected to Hartmann or Miles procedures;
• emergency surgery candidates due to conditions like perforation or obstruction;
• diagnosis of multiple primary malignancies;
• intraoperative discovery of widespread implant metastases within the abdominal cavity;
• severe comorbidities;
• anastomotic recurrence of rectal cancer;
• patients who had undergone stapled hemorrhoidopexy

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Yifan Cheng

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: January 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)