Predictive Time-to-Event Model for Major Medical Complications After Colectomy

NCT05150548 | Unknown

• 1 other identifier: H21-02670
• Study Type: observational
• Target: 130,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Inflammatory Bowel Diseases; Diverticulitis; Colectomy; Predictive Model; Complications, Postoperative

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

Not applicable, non-interventional study

Entire Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• undergoing elective colectomy
• data has been collected in the NSQIP® Procedure Targeted Colectomy dataset from 2014-2019

You may not qualify if:

• American Society of Anesthesiologists (ASA) Physical Status (PS) V (defined as "5-Moribund") (ASA PS 6 - organ donation is not included within NSQIP)
• undergoing urgent or emergency surgery
• indication for colectomy consisting of "Acute diverticulitis", "Enterocolitis (e.g. C. Difficile)", and "Volvulus" due to the non-elective nature of these pathologies
• patient with disseminated cancer
• wound infection (i.e. potentially recent surgery)
• systemic sepsis
• ventilator-dependence preoperatively

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (6)

• 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.

  PMID: 24522747 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.

  PMID: 27926773 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.

  PMID: 12799329 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.

  PMID: 27986644 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.

  PMID: 30357870 BACKGROUND

• 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.

  PMID: 39621640 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases; Diverticulitis; Postoperative Complications

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Diverticular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janny Xue Chen Ke, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)