The Association of Marital Status With Kidney Cancer Surgery Morbidity

NCT ID: NCT05526599

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106752 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-01-01
• Study Completion Date: 2018-03-31

Brief Summary

Retrospective cohort study

Detailed Description

Data source and study cohort:

We conducted a retrospective cohort study using the Premier Healthcare Database (PHD, Premier Inc., Charlotte, NC), an extensive, US hospital-based, all-payer database representing approximately 20% of annual United States inpatient discharges at community and academic centers. The International Classification of Diseases, ninth revision (ICD-9), and tenth revision (ICD-10) procedure codes were used to identify patients who had undergone elective kidney cancer surgery between the 15 years of study from 2003 to 2017. The cohort was then restricted based on appropriate ICD-9 and ICD-10 diagnosis codes to ensure that surgery was performed for a kidney mass. The study cohort was also limited to adult patients (age >= 18 years), "elective" cases based on administrative codes, as well as surgery on hospital day zero or one to minimize outlier patients who could skew the surgical outcomes.

Outcomes:

The primary outcome of this study was the 90-day complication rate. Complication rates were based on the Clavien-Dindo classification of surgical complications and divided into four categories: no complications, minor complications (Clavien grades 1, 2), and non-fatal major complications (Clavien grades 3, 4), and mortality (Clavien grade 5). Clinical systems also categorized complications (bleeding, cardiac, endocrine, gastrointestinal, infection, neurology, pulmonary, renal, soft tissue, urologic, venous thromboembolism) using Health Care Cost and Utilization Project Clinical Classification Software Level II or III designations; of note, the category for "surgical" complications was excluded given that all complications captured in this analysis are considered surgical complications. Secondary outcomes included patient disposition, length of hospital stay, and readmission rate.

Conditions

Marriage; Kidney Neoplasms; Surgery-Complications; Cohort Studies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Surgery was performed for a kidney mass.

2. age >= 18 years

3. "elective" cases

4. Surgery was performed on the day0 or day1 after administration.

Exclusion Criteria

1. ICD codes are not available.

2. Missing value of the primary outcomes and exposure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuzhe Tang

Clinical Attending

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

42746034

Identifier Type: -

Identifier Source: org_study_id