Surgery Clinical Trial
Official title:
African Surgical Outcomes Study (ASOS): An African, Multi-centre Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult
surgical patients in Africa.
STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study
of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum
of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study
design.
The primary outcome is in-hospital postoperative complications in adult surgical patients in
Africa. Secondary outcomes include in-hospital mortality and the relationship between
postoperative complications and postoperative mortality.
The intention is to present a representative sample of surgical outcomes across all African
countries. This study will run between February and March 2016.
Research questions
Primary objective To confirm the incidence of in-hospital postoperative complications in
adult surgical patients in Africa Secondary objectives
1. To confirm the rate of mortality on the day of surgery for patients undergoing surgery
in Africa.
2. To confirm the in-hospital mortality rate for patients undergoing surgery in Africa.
3. To describe the relationship between postoperative complications and postoperative
mortality.
4. To describe the proportional contribution of communicable, non-communicable diseases
and traumatic injuries to in-hospital mortality and critical care admissions in Africa.
Methods Seven day, African national multi-centre cohort study of adult (≥18 years) patients
undergoing surgery. This study will be registered on ClinicalTrials.gov.
Inclusion criteria All consecutive patients admitted to participating centres undergoing
elective and non-elective surgery commencing during a seven day study cohort period with a
planned overnight hospital stay following surgery. The recruitment week will run between
February and March 2016.
Exclusion criteria Patients undergoing planned day-case surgery or radiological procedures
not requiring anaesthesia.
Centres Our plan is to recruit as many centres as possible on an international basis and ask
them to include all eligible patients in the study.
Number of centres. We plan to recruit as many centres from each country for participation.
Countries are expected to contribute data from at least 10 centres. Where countries have
less than 10 centres performing surgery nationally, at least 50% of the surgical centres
need to contribute data to ASOS.
Number of patients Only centres which provide patient data on at least 90% of the eligible
surgical cases for the recruitment week will be included in the data analysis. The selected
recruitment week for a country will be decided by the National Leader.
Ethics approval The requirement for patient consent is expected to vary according to
regulations of the participating nations. The national leaders will ensure ethics approval
is obtained from their respective countries and centres. Centres will not be permitted to
record data unless ethics approval or an equivalent waiver is in place.
This study is in effect a large scale clinical audit. We expect that in most, if not every
country, that there will be no requirement for individual patient consent as all data will
be anonymised and is already recorded as part of routine clinical care. This international
precedent has already been set, as in the original European Surgical Outcomes Study (EuSOS),
consent was waived in 27 of the 28 European countries participating, and seven of the eight
ethics committees in the South African Surgical Outcomes Study (SASOS).
Data collection and collation Data will be collected in individual centres on paper case
record forms (CRFs) for every patient recruited. Paper CRFs will be stored within a locked
office in each centre as they will include identifiable patient data in order to allow
follow-up of clinical outcomes. Data will then be pseudo-anonymised by generation of a
unique numeric code and transcribed by local investigators onto an internet based electronic
CRF. Each patient will only be identified on the electronic CRF by their numeric code; thus
the co-ordinating study team cannot trace data back to an individual patient without contact
with the local team. A participant (patient) list will be used in each centre to match
identifier codes in the database to individual patients in order to record clinical outcomes
and supply any missing data points. Access to the data entry system will be protected by
username and password delivered during the registration process for individual local
investigators. All electronic data transfer between participating centres and the
co-ordinating centre will be encrypted using a secure protocol.
Where individual centres are unable to access the internet based case record form,
pseudo-anonymised (coded) facsimile (fax) data transfer will be available to a secure,
dedicated fax machine in the co-ordinating office. Pseudo-anonymised (coded) data may also
be sent by mail to the coordinating centre if necessary.
Each centre will complete a screening log reporting the number of eligible surgical patients
who had surgery during the recruitment week at the centre.
Each centre will maintain a secure trial file including a protocol, local investigator
delegation log, ethics approval documentation and the patient list.
Once the local co-ordinator confirms data entry is complete for their hospital they will
receive a spreadsheet of raw (un-cleaned) data, allowing further checks for data
completeness and accuracy.
Dataset A realistic data set will be fundamental to the success of the investigation, and
this was confirmed in the EuSOS study where nearly complete data was available on 46 000
patients, and similarly in the SASOS study. We have therefore adopted core data variables
from the EuSOS, International Surgical Outcomes Study (ISOS) and SASOS studies in order to
achieve the study objectives. We believe that these key data points will encourage centres
to participate as there will not be an excessive burden of data collection.
Centre co-ordinators may request the addition of a limited number of data points to support
additional country specific data collection and for subsequent regional analyses. All
additional data points must be discussed with the co-principal investigators and if
necessary the steering committee.
Centre specific data will be collected once for each hospital including: university or
non-university hospital, number of hospital beds, number of operating rooms, number and
level of critical care beds and details about the reimbursement status of the hospital.
An ASOS case record form (CRF) will be completed for every eligible patient who undergoes
surgery during the seven day cohort period (appendix 1). Patients will be followed up until
hospital discharge. This will be censored at thirty days i.e. patients will be followed up
until discharge or for thirty days whichever is the shorter period.
Sample size calculation Our plan is to recruit as many centres as possible from each
participating country and ask them to include all eligible patients in the study. A minimum
of ten centres from any country will be required for participation (with the exception of
countries which have less than 10 centres performing surgery nationally, where in this
circumstance at least 50% of the surgical centres need to contribute data to ASOS). Only
centres including data on at least 90% of eligible patients will be included in the data
analysis. We do not have a specific sample size and statistical models will be adapted to
the event rate provided by the sample recruited.
Statistical analysis Data will be presented at a national level and in the following
geographical regions: Northern, Western, Central, Eastern and Southern Africa. All
institutional level data will be anonymised prior to publication. Categorical variables will
be described as proportions and will be compared using chi-square tests. Continuous
variables will be described as mean and standard deviation if normally distributed or median
and inter-quartile range if not normally distributed. Comparisons of continuous variables
between groups will be performed using t-tests, one-way ANOVA or equivalent non parametric
tests as appropriate. Univariate analysis will be performed to test factors associated with
postoperative complications, critical care admission and in-hospital death.
Single-level and hierarchical multi-level logistic regression models will be constructed to
identify factors independently associated with these outcomes and to adjust for differences
in confounding factors. Factors will be entered into the models based on their univariate
relation to outcome (p<0.05), biological plausibility and low rate of missing data.
Results of logistic regression will be reported as adjusted odds ratios (OR) with 95%
confidence intervals. The models will be assessed through the use of sensitivity analyses to
explore possible interacting factors and examine any effect on the results. A single final
analysis is planned at the end of the study.
Primary outcome measure Incidence of in-hospital postoperative complications in adult
surgical patients in Africa.
Secondary outcome measures
1. Rate of mortality on the day of surgery for patients undergoing surgery in Africa.
2. The in-hospital mortality rate for patients undergoing surgery in Africa.
Organisation The Steering Committee will be chaired by Bruce Biccard (BB) and Thandinkosi
Madiba (TM). The study management team will be appointed by the Steering Committee and led
by BB and TM. The duties of this team will include administration of all project tasks,
communication between project partners (including funders, steering committee members,
national and local co-ordinators, etc.), data collation and management and preparation of
reports for individual study sites. The Steering Committee is responsible for the scientific
conduct and consistency of the project. The Steering Committee will ensure communication
between the funder(s), study management team and co-ordinators as necessary.
Country co-ordinators
Country co-ordinators will be appointed by the steering committee to lead the project within
individual countries and:
- Identify local co-ordinators in participating hospitals
- Assist with translation of study paperwork as required
- Ensure distribution of research manuals, CRF and other materials
- Ensure necessary regulatory approvals are in place prior to the start date
- Ensure good communication with the participating sites in his/her country
Local co-ordinators
Local co-ordinators in individual institutions will have the following responsibilities:
- Provide leadership for the study in their institution
- Ensure all relevant regulatory approvals are in place for their institution
- Ensure adequate training of all relevant staff prior to data collection
- Supervise daily data collection and assist with problem solving
- Act as guarantor for the integrity and quality of data collected
- Ensure timely completion of CRFs
- Communicate with the relevant national coordinator
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |