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Completed

NCT Number: NCT06404554

A Prediction Model of Anastomotic Stricture After Rectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Anastomotic Stenosis Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yifan Cheng

Yangzhou, Jiangsu, 225000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

without any intervention

Other

without any intervention

Primary outcomes

  1. patients with anastomotic stricture

    Time frame: up to six months

    Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis

  2. patients without anastomotic stricture

    Time frame: up to six months

    Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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