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Purpose: The purpose of this study is to create prediction models for when major complications occur after elective colectomy surgery.
Justification: After surgery, patients can have multiple complications. Accurate risk prediction after surgery is important for determining an appropriate level of monitoring and facilitating patient recovery at home.
Objectives: Investigators aim to develop and internally validate prediction models to predict time-to-complication for each individual major medical complications (pneumonia, myocardial infarction (MI) (i.e. heart attacks), cerebral vascular event (CVA) (i.e. stroke), venous thromboembolism (VTE) (i.e. clots), acute renal failure (ARF) (i.e. kidney failure), and sepsis (i.e. severe infections)) or adverse outcomes (mortality, readmission) within 30-days after elective colectomy.
Data analysis: Investigators will be analyzing a data set provided by the National Surgical Quality Improvement Program (NSQIP). Descriptive statistics will be performed. Cox proportional hazard and machine learning models will be created for each complication and outcome outlined in "Objectives". The performances of the models will be assessed and compared to each other.
Background: Planned (elective or time sensitive) colectomy are performed for indications including cancer, inflammatory bowel disease (IBD), and diverticulitis. After colectomy, patients are at risk of a variety of major medical complications, including pneumonia, myocardial infarction (MI), cerebral vascular event (CVA), venous thromboembolism (VTE), acute renal failure (ARF), and sepsis. However, different complications tend to happen at different times after surgery. Accurate risk prediction, not only whether a complication may occur in a patient, but also when, is crucial for patient education, monitoring, and disposition planning. While several studies have explored the incidence and binary risk prediction for major complications after surgeries, there has been scarce literature on time-to-complication prediction modeling in recent population cohort data.
Objectives
Methods: Investigators will conduct a time-to-event survival analysis in a retrospective cohort using NSQIP®, a prospectively-collected multicentre dataset with more than 150 clinical variables within 30 days after surgery. This dataset includes information on whether the patient was diagnosed with major complications (in- or out-of-hospital) as well as the number of postoperative days to the diagnoses of complications, as defined by a standardized criteria within the NSQIP operations manual. The general dataset will be linked with the NSQIP® Procedure Targeted Colectomy dataset, which contains additional colectomy-specific variables.
The study will be reported according to the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines and Guidelines for Developing and Reporting Machine Learning Predictive Models in Biomedical Research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entire Cohort | Patients undergoing elective colectomy with data that has been collected in the NSQIP® Procedure Targeted Colectomy dataset from 2014-2019 with American Society of Anesthesiologists (ASA) Physical Status I-IV. Patients will not be included in this cohort with urgent or emergency colectomy or indication for colectomy consisting of "Acute diverticulitis", "Enterocolitis (e.g. C. Difficile)", and "Volvulus", patients with disseminated cancer, wound infection, systemic sepsis or ventilator-dependence preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | Not applicable, non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pneumonia | Occurrence of pneumonia within 30 days post-operatively. | Within 30 days post-operatively |
| Myocardial Infarction (MI) | Occurrence of Myocardial Infarction within 30 days post-operatively. | Within 30 days post-operatively |
| Cerebral Vascular Event (CVA) | Occurrence of Myocardial Infarction within 30 days post-operatively. | Within 30 days post-operatively |
| Venous Thromboembolism (VTE) | Occurrence of Venous Thromboembolism within 30 days post-operatively. | Within 30 days post-operatively |
| Acute Renal Failure (ARF) | Occurrence of Acute Renal Failure within 30 days post-operatively. | Within 30 days post-operatively |
| Sepsis or septic shock | Occurrence of sepsis or septic shock within 30 days post-operatively. | Within 30 days post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include all patients who are 18 years or older undergoing elective colectomy, whose data has been collected in the NSQIP® Procedure Targeted Colectomy dataset from 2014-2019, inclusively.
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| Name | Affiliation | Role |
|---|---|---|
| Janny Xue Chen Ke, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24522747 | Background | Morris MS, Deierhoi RJ, Richman JS, Altom LK, Hawn MT. The relationship between timing of surgical complications and hospital readmission. JAMA Surg. 2014 Apr;149(4):348-54. doi: 10.1001/jamasurg.2013.4064. | |
| 27926773 | Background | Scarborough JE, Schumacher J, Kent KC, Heise CP, Greenberg CC. Associations of Specific Postoperative Complications With Outcomes After Elective Colon Resection: A Procedure-Targeted Approach Toward Surgical Quality Improvement. JAMA Surg. 2017 Feb 15;152(2):e164681. doi: 10.1001/jamasurg.2016.4681. Epub 2017 Feb 15. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2021 | Nov 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D004238 | Diverticulitis |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 12799329 | Background | Thompson JS, Baxter BT, Allison JG, Johnson FE, Lee KK, Park WY. Temporal patterns of postoperative complications. Arch Surg. 2003 Jun;138(6):596-602; discussion 602-3. doi: 10.1001/archsurg.138.6.596. |
| 27986644 | Background | Luo W, Phung D, Tran T, Gupta S, Rana S, Karmakar C, Shilton A, Yearwood J, Dimitrova N, Ho TB, Venkatesh S, Berk M. Guidelines for Developing and Reporting Machine Learning Predictive Models in Biomedical Research: A Multidisciplinary View. J Med Internet Res. 2016 Dec 16;18(12):e323. doi: 10.2196/jmir.5870. |
| 30357870 | Background | Riley RD, Snell KI, Ensor J, Burke DL, Harrell FE Jr, Moons KG, Collins GS. Minimum sample size for developing a multivariable prediction model: PART II - binary and time-to-event outcomes. Stat Med. 2019 Mar 30;38(7):1276-1296. doi: 10.1002/sim.7992. Epub 2018 Oct 24. |
| 39621640 | Derived | Ke JXC, Jen TTH, Gao S, Ngo L, Wu L, Flexman AM, Schwarz SKW, Brown CJ, Gorges M. Development and internal validation of time-to-event risk prediction models for major medical complications within 30 days after elective colectomy. PLoS One. 2024 Dec 2;19(12):e0314526. doi: 10.1371/journal.pone.0314526. eCollection 2024. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |
| D000076385 | Diverticular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |