The Association of Marital Status With Kidney Cancer Surgery Morbidity

Completed

• Conditions: Surgery-Complications; Cohort Studies; Marriage; Kidney Neoplasms

• Registration Number: NCT05526599
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Study Timeline

• Study Start: 2003-01-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106752

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.

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Exclusion Criteria

1. ICD codes are not available.
2. Missing value of the primary outcomes and exposure.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
surgical complications	90 days after surgery	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).

Secondary Outcome Measures

Name	Time	Method
patient disposition	90 days after surgery	patient disposition was divided into home and none home such as skilled nursing or rehabilitation facility
readmission rates	90 days after surgery	readmission was defined as readmitted into the hospital for any reason