MarriageNCT05526599
The Association of Marital Status With Kidney Cancer Surgery Morbidity
An observational study of Marriage and Kidney Neoplasms, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
Retrospective cohort study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marriage, Kidney Neoplasms, Surgery-Complications
- How many people
- 106,752 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Surgery was performed for a kidney mass.
- age >= 18 years
- "elective" cases
- Surgery was performed on the day0 or day1 after administration.
Who cannot join
- ICD codes are not available.
- Missing value of the primary outcomes and exposure.
About this study
Retrospective cohort study
Read the 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
- Keywords
- Marital Status, Kidney Cancer Surgery, Surgical Morbidity, Retrospective Cohort Study
- Medical subject headings
- Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days after surgery
Secondary outcomes (2)
patient disposition
patient disposition was divided into home and none home such as skilled nursing or rehabilitation facility
Measured: 90 days after surgery
readmission rates
readmission was defined as readmitted into the hospital for any reason
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2003
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MarriageStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Yuzhe Tang, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526599
- Sponsor's protocol ID
- 42746034
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Marital Status With Kidney Cancer Surgery Morbidity
- ClinicalTrials.gov ID
- NCT05526599
- Acronym / sponsor ID
- 42746034
- Conditions
- Marriage, Kidney Neoplasms, Surgery-Complications, Cohort Studies
- Keywords
- Marital Status, Kidney Cancer Surgery, Surgical Morbidity, Retrospective Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106,752 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Surgery was performed for a kidney mass.
- age >= 18 years
- "elective" cases
- Surgery was performed on the day0 or day1 after administration.
Key exclusion criteria (2 listed)
- ICD codes are not available.
- Missing value of the primary outcomes and exposure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
surgical complications
Time frame: 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).
2 secondary outcomes
patient disposition
Time frame: 90 days after surgery
readmission rates
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Marriage and Kidney Neoplasms, run by Beijing Tsinghua Chang Gung Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical complications (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.