The Association of Marital Status With Kidney Cancer Surgery Morbidity

Kidney Neoplasms Clinical Trial

Official title:

The Association of Marital Status With Kidney Cancer Surgery Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05526599
• Other study ID #: 42746034
• Status: Completed
• Start date: January 1, 2003
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2022
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective cohort study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106752
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Cohort Studies
• Kidney Neoplasms
• Marriage

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital	Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical complications	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).	90 days after surgery
Secondary	patient disposition	patient disposition was divided into home and none home such as skilled nursing or rehabilitation facility	90 days after surgery
Secondary	readmission rates	readmission was defined as readmitted into the hospital for any reason	90 days after surgery