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A Prediction Model of Anastomotic Stricture After Rectal Cancer

N

Northern Jiangsu People's Hospital

Status

Completed

Conditions

Anastomotic Stenosis
Rectal Cancer
Colorectal Cancer

Treatments

Other: without any intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06404554
NorthernJiangsu004

Details and patient eligibility

About

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.

Enrollment

1,542 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,542 participants in 2 patient groups

patients with anastomotic stricture
Description:
without any intervention, patients diagnose as anastomotic stricture after rectal cancer surgery
Treatment:
Other: without any intervention
patients without anastomotic stricture
Description:
without any intervention, patients does not diagnose as anastomotic stricture after rectal cancer surgery
Treatment:
Other: without any intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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