Clinical trial NCT05526599: The Association of Marital Status With Kidney Cancer Surgery Morbidity
Official title: The Association of Marital Status With Kidney Cancer Surgery Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Marriage
Kidney Neoplasms
Surgery-Complications
Cohort Studies
Keywords: Marital Status
Kidney Cancer Surgery
Surgical Morbidity
Retrospective Cohort Study
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2022-09-02
Enrollment: 106752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: surgical complications
timeFrame: 90 days after surgery
Secondary outcomes:
measure: patient disposition
timeFrame: 90 days after surgery
measure: readmission rates
timeFrame: 90 days after surgery
Other outcomes:
Locations:
Study officials:
References: