Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03052504 |
| Other study ID # |
CSA-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
February 2018 |
Study information
| Verified date |
June 2018 |
| Source |
Aarhus University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study will examine which differences there are in comorbidity and complications collected
retrospectively from medical records compared with data collected prospectively in two groups
of patients undergoing either radical cystectomy or radical nephrectomy.
Hypothesis is that he prevalence of registered comorbidity and minor complications in
patients who have undergone radical cystectomy or nephrectomy, will increase if the data
collection is focused and prospective, compared with retrospectively collected data.
The study will be conducted as a single-blind randomized controlled trial. Patients included
in the study will be randomized to either control or intervention in the ratio 1:1. There are
two groups of patients: Patients admitted to radical cystectomy and patients admitted to
radical nephrectomy, due to cancer.
Description:
Background:
Today there are many different systems to classify co morbidity and complication of radical
cystectomy and nephrectomy. Regarding complication, there is Clavien Dindo classifications
System and The National Surgical Quality Improvement Program (NSQIP) while Charlson
Comorbidity Index (CCI) and Eastern Cooperative Oncology Group (ECOG) performance scale
classifies comorbidity. At the present time, there is not a system that takes both parameters
into account, although it is of high clinical relevance to be able to figure out the
significant and important patient parameters that can influence the outcome of a treatment
modality. Such a system is in development, from cystectomy patients, in this study's project
group. This is currently to be validated in two large patient cohorts from respectively
Herlev Hospital and Memorial Sloan Kettering Cancer Center, New York, USA. Virtually all
previous publications on comorbidity or complications after cancer surgery, including the
aforementioned, is based on data retrospectively collected from medical records. Even
prospectively maintained database are based predominantly on data from records written in the
journal prospective, but then transferred retrospectively to the database. The problem is
that data on comorbidities and complications are not collected with this registration method
in mind. Especially in the definition of the individual complications this contains a
significant source of error. In addition, most minor complications that do not require
re-intervention or re-operation, are probably underreported. Involvement of lesser
complications after discharge is rarely reported, unless they lead to readmission. This is
probably one of the causes of an uneven distribution in the reporting of serious
complications requiring re-operation when comparing surgical case series, while the number of
minor complications (Clavien 1-2) are highly variable. Even a minor complication which does
not cause a readmission, can have a major impact on a patient's quality of life and
experience of the disease. In addition, the small complications are often preventable, if you
have a knowledge of their cause and context with the intervention. Patients who are to
undergo cystectomy, are predominantly elderly patients with a large tobacco consumption and
high comorbidity. At the same time cystectomy is associated with the highest risk of
complications (75%) in cancer surgery, followed by nephrectomy patients (20%). Kidney cancer,
and especially bladder cancer has a high- 1- and 5-year survivalrate. The patients will
likely live for many years with their complications and the potential impact on quality of
life as a result.
Since current knowledge and previous publications on comorbidity and/or complications after
cancer surgery often is build on retrospective collected data, it will be highly relevant to
examine the extent to which the retrospectively collected data is accurate by comparing with
prospectively collected data. By conducting this study, it can be assessed which kind of
gathering gives the correct information on the complications of radical cancer surgery and if
previous publications should be revalidated?
Aim of the study The study will examine which differences there are in comorbidity and
complications collected retrospectively from medical records compared with data collected
prospectively.
Hypothesis The prevalence of registered comorbidity and minor complications in patients who
have undergone radical cystectomy or nephrectomy, will increase if the data collection is
focused and prospective, compared with retrospectively collected data.
Design The study will be conducted as a single-blind randomized controlled trial, as this
form of study eliminates unknown confounders and have a high validity. Patients included in
the study will be randomized to either control or intervention in the ratio 1:1. There are
two groups of patients: Patients admitted to radical cystectomy and patients admitted to
radical nephrectomy, due to cancer.
Study procedure In the control groups data on comorbidity and complications are collected
retrospectively from medical records 90 days after the end of treatment, based on clearly
defined criteria for comorbidity and complications, and severity of these (Clavien
gradation). In the intervention group the investigator must collect information on
comorbidity, preoperative, in a systematic review with a questionnaire in cooperation with
the patient. Details about complications is collected daily at bedside, at rounds, by the
investigator. Additionally, the patient receives a questionnaire at discharge. This must be
answered at home. The investigator and the patient will go through the questionnaire at the
first visit to the ambulatory. A second and identical questionnaire, in a stamped envelope,
is handed out to the patient. In the last two questionnaires the patient must record contact
with the family doctor, emergency physician, nurse and other hospital departments.
Furthermore, any kind of medicine, pain or disability must be described. In the intervention
group the same defined criteria are used as in the control group. Physicians involved in the
management of the patient, is blinded to the group to which the patient is randomly assigned
to, and is thus unaware of whether the patient is in the intervention group or the control
group. Subsequently for the intervention group a retrospective collection of data from
medical records is made and compared with the control group. This ensures that the
randomization has been sufficient.
Primary endpoints
- Prevalence of procedure related complications (Clavien score)
- During hospitalization postoperative before discharge
- Within the first week after discharge
- Within the second week after discharge
- Prevalence of preoperative comorbidity
Secondary Endpoints
- Patient comorbidity: Acute myocardial infarction, angina pectoris, arrhythmias, previous
cardiac surgery, venous diseases, hypertension, hypercholesterolemia, abdominal aortic
aneurysm, claudicatio, chronic obstructive pulmonary disease, peptic ulcer, alcohol
abuse, liver disease, stroke, diabetes mellitus type I and II, connective tissue
disease, osteoporosis, kidney transplant, kidney failure, leukemia/lymphoma, previous
malignant disease with & without metastases.
- Patient complication: antiemetics, antipyretics, antibiotics, diuretics, VAS (Visual
Analog Pain Scale) score, newly started or increased help from home care, newly started
or more visits from the home nurse, newly started physical therapy, blood transfusion
- Is there a significant variation in comorbidity collected from questionnaires and
medical records, respectively.
Statistics and sample size The number of patients in the study is based on the following
assumptions: For the cystectomy- and nephrectomy patients with complications retrospectively
calculated, it is assumed that complications that needs intervention is detected respectively
about 50% and 20%. This is in accordance with the highest indication in major international
surveys with retrospective registering. Based on previous experiences, the real number is
estimated to be respectively minimum 85% and 35%. With an alpha value at 0,05 and a beta
value at 0,20, this gives a required number of patients at 66 for cystectomy patients and 90
nephrectomy patients, to be able to demonstrate a significant difference.
Statistical analyses will be performed with primarily non-parametric test using MedCalc for
Windows, version 15.8 or later (MedCalc Software, Ostend, Belgium).
Data management Patients will be enrolled after signing informed consent. Patient data will
be entered directly into the electronic CRF (Clinical Registration Form) on a secure server
using REDCap, which is a secure server based system with a security that exceeds the demands
and guidelines of "Persondataloven" and is recommended by Aarhus University. Data are stored
according to regulations by the Danish Data Protections Agency.
Perspectivation If the study concludes that the project groups classification system is based
on valid data and find out what kind of data collection that provides the most accurate
picture of the patients relationship between co-morbidities and complications, we will in
future be able to give patients more individualized treatment. This is desirable both for the
patient and the therapist. In this way the study classification system will be able to avoid
the patient living a life with post operative complications and a complicated treatment. This
will also be able to reduce the use of health care resources, that can then be uses
elsewhere.
Ethical considerations The study will be conducted in accordance with the protocol,
applicable regulatory requirements and the ethical principles of the Declaration of Helsinki
as adopted by the 18th World Medical Assembly in Helsinki, Finland in 1064 and subsequent
versions.
The patients that by informed consent is included in the study, are exposed neither to
different surgery or other treatment than they would have been without participation in the
study. The extra interviews and daily rounds will attempt established in connection with the
patient's usual attendance and stay at the hospital, to avoid extra visits. There must be
calculated some extra time spent in connection with participation in the trial. Studies show
that patients in scientific studies, feel that they receive a better treatment.
The study is approved in the Data Inspectorate and assessment is ongoing in the Research
Ethics Committee, where approval is mandatory before starting.
Project feasibility The study is performed in an internationally acknowledged research
environment at department of urology, Aarhus University Hospital, Skejby. Baseline data are
collected until approximately May 2017 and follow-up data August 2017. This means that data
will be available in time to complete the thesis and a paper for publication. The research
year student will be affiliated to the department. All necessary analysis methods are
established in the department, and hardware and software will be provided.
