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NCT Number: NCT05129215

Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)

Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Radiotherapy Rectal Cancer Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Curative low anterior resection for nonmetastatic rectal cancer
  • Preoperative radiotherapy

Exclusion criteria

  • Death
  • Metastasis or recurrence
  • Postoperative radiotherapy
  • Cognitive disorder
  • Intestinal stoma
  • Rectal cancer resection for <12 months
  • Stoma reversal for <6 months

Treatment and study plan

Questionnaire

Other

The LARS score is used for assessment of bowel dysfunction after rectal cancer resection.

Primary outcomes

  1. Area under the curve (AUC)

    Time frame: Over one year after restorative rectal cancer resection

    The AUC of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.

    The AUC is evaluated by calculating the area under curve of receiver operating characteristics which plots the proportion of true positive cases (sensitivity) against the proportion of false positive cases (1-specificity) based on various predictive probability threshold.

Secondary outcomes

  1. Sensitivity

    Time frame: Over one year after restorative rectal cancer resection

    The sensitivity of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.

    Model sensitivity is evaluated by calculating the proportion of the 'predicted major LARS' subjects among the total 'actual major LARS' subjects.

  2. Specificity

    Time frame: Over one year after restorative rectal cancer resection

    The specificity of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.

    Model specificity is evaluated by calculating the proportion of the 'predicted no/minor LARS' subjects among the total 'actual no/minor LARS' subjects.

  3. Positive prediction value (PPV)

    Time frame: Over one year after restorative rectal cancer resection

    The PPV of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.

    Model PPV is evaluated by calculating the proportion of the 'actual major LARS' subjects among the total 'predicted major LARS' subjects.

  4. Negative prediction value (NPV)

    Time frame: Over one year after restorative rectal cancer resection

    The NPV of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.

    Model NPV is evaluated by calculating the proportion of the 'actual no/minor LARS' subjects among the total 'predicted no/minor LARS' subjects.

Other outcomes

  1. Net reclassification index (NRI)

    Time frame: Over one year after restorative rectal cancer resection

    The additive NRI of PORTLARS compared to other models is evaluated by calculating the percentage of the 'actual major LARS' subjects correctly reclassified to the percentage of the 'actual no/minor LARS' subjects who are correctly reclassified.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Collaborators

  • Beijing Friendship Hospital
  • Peking University Cancer Hospital & Institute

Registry information

Official study title

Development and Validation of a Nomogram to Predict Severe Bowel Dysfunction After Rectal Cancer Resection and Neoadjuvant Radiotherapy: A Multicenter, Observational Clinical Study

Acronym: PORTLARS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Nov 30, 2022

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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