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

Sun Yat-sen University

Status: Completed

Conditions: Radiotherapy; Low Anterior Resection Syndrome; Rectal Cancer

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05129215

E2020016

Details and patient eligibility

About

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.

Enrollment: 901 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

901 participants in 3 patient groups

Development

Description:

A primary cohort of eligible patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model derivation.

Treatment:

Other: Questionnaire

Internal cross-validation

Description:

A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for internal cross-validation.

Treatment:

Other: Questionnaire

External validation

Description:

An independent cohort of eligible patients from other hospitals is used for external validation.

Treatment:

Other: Questionnaire