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

NCT05129215 | Completed

• 1 other identifier: E2020016
• Study Type: observational
• Target: 901
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Anterior Resection Syndrome; Radiotherapy; Rectal Cancer

Keywords

Bowel Dysfunction; Low Anterior Resection Syndrome; Radiotherapy; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC)

  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.

  Over one year after restorative rectal cancer resection

Secondary Outcomes (4)

• Sensitivity

  Over one year after restorative rectal cancer resection

• Specificity

  Over one year after restorative rectal cancer resection

• Positive prediction value (PPV)

  Over one year after restorative rectal cancer resection

• Negative prediction value (NPV)

  Over one year after restorative rectal cancer resection

Other Outcomes (1)

• Net reclassification index (NRI)

  Over one year after restorative rectal cancer resection

Study Arms (3)

Development

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

Other: Questionnaire

Internal cross-validation

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

Other: Questionnaire

External validation

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

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Development; External validation; Internal cross-validation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent preoperative radiotherapy and curative low anterior resection for nonmetastatic rectal cancer.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Peking University Cancer Hospital & Institute: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Qin Q, Huang B, Wu A, Gao J, Liu X, Cao W, Ma T, Kuang Y, Guo J, Wu Q, Shao B, Guan Q, Yao H, Zhang X, Wang H; Chinese Radiation Intestinal Injury Research Group. Development and Validation of a Post-Radiotherapy Prediction Model for Bowel Dysfunction After Rectal Cancer Resection. Gastroenterology. 2023 Dec;165(6):1430-1442.e14. doi: 10.1053/j.gastro.2023.08.022. Epub 2023 Aug 23.

  PMID: 37625498 DERIVED

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms; Intestinal Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colonic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Qiyuan Qin, M.D.

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 22, 2021
• Study Start: March 6, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CN (1)