Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Beijing Friendship Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Development | A primary cohort of eligible patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model derivation. |
| |
| Internal cross-validation | A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for internal cross-validation. |
| |
| External validation | An independent cohort of eligible patients from other hospitals is used for external validation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | The LARS score is used for assessment of bowel dysfunction after rectal cancer resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | 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. | Over one year after restorative rectal cancer resection |
| Measure | Description | Time Frame |
|---|---|---|
| Net reclassification index (NRI) | 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. | Over one year after restorative rectal cancer resection |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients who underwent preoperative radiotherapy and curative low anterior resection for nonmetastatic rectal cancer.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Qiyuan Qin, M.D. | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37625498 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| D012004 | Rectal Neoplasms |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Specificity | 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. | Over one year after restorative rectal cancer resection |
| Positive prediction value (PPV) | 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. | Over one year after restorative rectal cancer resection |
| Negative prediction value (NPV) | 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. | Over one year after restorative rectal cancer resection |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |