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

NCT ID: NCT05129215

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

901 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-06

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Anterior Resection Syndrome Radiotherapy Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Development

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

Questionnaire

Intervention Type OTHER

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

Internal cross-validation

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

Questionnaire

Intervention Type OTHER

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

External validation

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

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiyuan Qin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37625498 (View on PubMed)

Other Identifiers

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E2020016

Identifier Type: -

Identifier Source: org_study_id

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