Clinical trial · Observational
Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Development and Validation of a Nomogram to Predict Severe Bowel Dysfunction After Rectal Cancer Resection and Neoadjuvant Radiotherapy: A Multicenter, Observational Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Development
- description
- A primary cohort of eligible patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model derivation.
- interventionNames
- Other: Questionnaire
- label
- 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.
- interventionNames
- Other: Questionnaire
- label
- External validation
- description
- An independent cohort of eligible patients from other hospitals is used for external validation.
- interventionNames
- Other: Questionnaire
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDQin 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