FAQs

How will SAPSOS run?

SAPSOS has been modelled on the EuSOS, ISOS and SASOS studies. Every participating hospital will collect data on a minimum of 90% of every eligible patient (but preferably all eligible patients) who have surgery during the study recruitment weeks. Patients will be followed until hospital discharge or for a maximum of 30 days if still in-hospital. Data on preoperative risk factors, surgical factors and patient outcome will be collected. Data will be collected on paper and then entered onto a secure website. Analysis will then start once data collection is complete.

Can anyone take part?

We would welcome as many hospitals as possible from South Africa to participate. Ideally every eligible study patient from the recruitment weeks will need to be included in the study.

When is the SAPSOS recruitment week?

The SAPSOS recruitment will be over two week and will run from 22 May 2017 until 5 June 2017. If your hospital has difficulty with these weeks, we can allow recruitment for a two week period on either side of theses dates.

Which patients are to be included in SAPSOS?

Every paediatric patient aged less than 16 years of age who undergoes surgery which starts (i.e. induction of anaesthesia) during the fourteen day cohort period. This will include inpatients, patients having day case surgery and operative procedures outside operating theatres where a general anaesthetic (GA) is performed.

Do we include emergency surgery patients?

Yes, we do include emergency surgery patients.

Should we recruit every patient who fits the inclusion criteria?

Yes, we want you to collect data which describes the whole paediatric surgical population in South Africa in order to fully understand what happens to our patients. This means we need to aim to collect data on every patient who fits the study inclusion criteria.

SAPSOS seems like it will be a lot of work?

We realise taking part in SAPSOS involves extra work and we appreciate the participation of all the investigators. In order to minimize the burden of data collection we have carefully limited the amount of data collection required, and limited the study cohort recruitment to only two weeks.

Is the data from my hospital important?

Yes. We know very little about the epidemiology of surgery and anaesthesia in paediatric patients and the associated outcomes in South Africa. In order to fully understand paediatric surgical outcomes in South Africa, it is important to include as many different hospitals as possible.

Will my work be recognized?

Yes. All local investigators registered through the SAPSOS website are members of the SAPSOS study group. All SAPSOS publications will be published on behalf of the SAPSOS study group.

SAPSOS CRF (case record form) frequently asked questions

What happens if my patient has surgery twice during the recruitment week?

What happens if my patient has surgery twice during the recruitment week?

Patients should only be included once in the study. Repeat surgery should only be included if the first procedure took place before the SAPSOS recruitment week began.

What is the American Society of Anesthesiologists (ASA) score?

What is the American Society of Anesthesiologists (ASA) score?

  • I A normal healthy patient
  • II A patient with mild systemic disease which does not limit physical activity
  • III A patient with severe systemic disease which limits physical activity
  • IV A patient with severe systemic disease that is a constant threat to life
  • V A patient who is not expected to survive for 24 hours without the operation.

What is the definition of neurosurgery?

What is the definition of neurosurgery?

Neurosurgical procedures are defined as involving the brain and cervical spine. Surgery on the thoracic and lumbar spine is defined as orthopaedic surgery in the CRF.

What should I do if some important medical co-morbidities are not included on the CRF?

What should I do if some important medical co-morbidities are not included on the CRF?

We realise that some patients may have important data which we have not asked for. The CRF has been designed to request only the most important patient data.

Some patients will not have blood tests routinely taken before surgery. Must we then take bloods for the patient?

Some patients will not have blood tests routinely taken before surgery. Must we then take bloods for the patient?

No. We do not want you to make any changes to the diagnostic tests or clinical treatment your patients would normally receive. If blood tests have not been done please leave this domain empty.

What if the data requested is not available?

What if the data requested is not available?

It is likely that some data such as blood results will not always be available. In other cases, an interpretation can be made e.g. the amount of blood loss may have to be estimated.

How do I calculate duration of surgery?

How do I calculate duration of surgery?

Duration of surgery is calculated from ‘anaesthetic induction time’ until ‘the end of surgery’. We realise that some patients will have regional techniques prior to general anaesthesia, and possibly in a ‘block room’ prior to transfer to the operating room. The ‘anaesthetic induction start time’ should be taken from the time of the first anaesthetic intervention i.e. if it is in a remote ‘block room’ then this is the anaesthetic start time. The ‘end of surgery’ is defined as the time at which the patient leaves the operating room.

How is the anaesthetic technique defined?

How is the anaesthetic technique defined?

  • General anaesthesia: Pharmacologically induced state of unconsciousness in order to facilitate surgical procedure
  • Sedation: Pharmacologically induced reduced level of consciousness during which verbal contact is maintained
  • Spinal anaesthesia: injection or infusion of a clinically effective dose of local anaesthetic and / or opioid drugs into the cerebro-spinal fluid in order to provide clinically effective anaesthesia
  • Epidural anaesthesia: injection or infusion of a clinically effective dose of local anaesthetic and / or opioid drugs into the epidural space in order to provide clinically effective anaesthesia and/or analgesia
  • Caudal anaesthesia: injection or infusion of a clinically effective dose of local anaesthetic into the epidural space through sacrococcygeal ligament via the sacral hiatus to provide clinically effective anaesthesia and/or analgesia
  • Other regional anaesthesia: injection or infusion of a clinically effective dose of local anaesthetic and / or opioid drugs into the region of a nerve or major nerve plexus in order to provide clinically effective anaesthesia and/or analgesia
  • Local anaesthesia: injection of a clinically effective dose of local anaesthetic into the tissues at the site of surgery in order to provide clinically effective anaesthesia and/or analgesia.

How is urgency of surgery defined in the SAPSOS study?

How is urgency of surgery defined in the SAPSOS study?

  • Elective: Not immediately life saving; planned within months or weeks.
  • Urgent: Planned surgery within hours or days of the decision to operate.
  • Emergency: As soon as possible; no delay to plan care; ideally within 24 hours.

What do you mean by ‘severity of the surgery’?

What do you mean by ‘severity of the surgery’?

This is the category of surgery which indicates a combination of complexity and amount of tissue injury.
  • Minor surgery would include procedures lasting less than 30 minutes performed in a dedicated operating room which would often involve extremities or body surface or brief diagnostic and therapeutic procedures . Examples include examination under anaesthesia, cystoscopy without intervention, removal of small cutaneous tumour, biopsy of small lesions, tenotomies, interventional radiology etc.
  • Intermediate procedures are more prolonged or complex that may pose the risk of significant complications or tissue injury. Examples include insertion of k-wires, tonsillectomy, inguinal hernia repair, appendicectomy, tendon repair of hand, cleft lip and palate repair, ventriculoperitoneal shunts, strabismus surgery etc.
  • Major surgical procedures are expected to last more than 90 minutes and include major Abdominal surgery, cardiac surgery, thoracotomy, procedures involving free flap to repair tissue defect, amputation, craniofacial surgery, craniotomy, cystectomy, resection of liver lesions, nephrectomy, transplant surgery, spinal surgery, osteotomy etc.

What is ‘primary indication for surgery’?

What is ‘primary indication for surgery’?

This is the underlying initiating disease/ event which ultimately resulted in the need for surgery. For example, should a patient present with a fractured humerus after a minor fall, but is found to have a malignant tumour at the fracture site, then the primary indication for surgery is ‘non-communicable disease’ i.e. cancer, and not ‘traumatic injury’ i.e. trauma, as the tumour preceded the fall. Another example is a patient presenting with an abscess for incision and drainage who is a diabetic. The underlying disease is diabetes and therefore the primary indication is “non-communicable”.

What defines ‘traumatic injury’ as the primary indication for surgery?

What defines ‘traumatic injury’ as the primary indication for surgery?

Injury is defined as damage or harm to the body resulting in impairment of health whether unintentional or intentional. It can result from exposure to thermal, mechanical, electrical, or chemical energies. The World Health Organization defines ‘Violence’ as the intentional use of physical force or power, threatened or actual, against oneself, another person, or against a group or community, which either results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation (World Health Organization, 2002). Unintentional injuries may include near drowning, falls, burns, motor vehicle accidents, poisonings, sports injuries and traumatic brain injury amongst others. Intentional injuries (or violence) may include assault, parasuicide, etc. Therefore ‘traumatic injury’ would include all intentional and unintentional injuries which were primarily responsible for surgery.

How should we estimate blood loss during surgery?

How should we estimate blood loss during surgery?

There many ways of calculating such an estimate of blood loss. This cannot be accurately measured and it would be too complex to standardise this. Instead we ask you to provide an estimate you believe to be reliable regardless of method.

How is critical care immediately after surgery defined?

How is critical care immediately after surgery defined?

These are patients who are transferred from the operating theatre straight to critical care or the intensive care unit.

How is critical care defined in SAPSOS?

How is critical care defined in SAPSOS?

We have defined a critical care unit as a facility routinely capable of admitting patients who require single or multiple organ support such as invasive ventilation overnight.

How do I find the unique SAPSOS identifier code for my patient?

How do I find the unique SAPSOS identifier code for my patient?

A unique code is created for each patient but not until you enter the data onto the internet based electronic case record form (eCRF).

What do you mean by the ‘most senior’ surgeon or anaesthetist?

What do you mean by the ‘most senior’ surgeon or anaesthetist?

We have decided to ask about the most senior staff member who is involved in the case and are present in the operating room. The most senior surgeon may not perform the operation themselves but watch a junior colleague do this. However, they are still the most senior surgeon in the operating room and could, for example, assist if something went wrong. The most senior surgeon may not be present in the operating room throughout the entire procedure. The same principles apply to anaesthetists.
  • ‘Specialist’ is a doctor who is registered as a specialist surgeon or anaesthetist.
  • ‘Physician non specialist’ is a doctor who performs the surgery or anaesthesia, but does not have specialist registration in the appropriate field i.e. surgery or anaesthesia
  • ‘Non physician or nurse anaesthetist’ is a person who is not a doctor, but is either performing the surgery or anaesthesia.

How is ‘days in critical care after surgery’ defined?

How is ‘days in critical care after surgery’ defined?

Duration of critical care stay after surgery is defined as the time in days from the day of admission to critical care until the day the patient leaves critical care. This will not be adjusted for delays relating to transfer step down units or wards. The total number of critical care days are recorded if there are multiple critical care admissions following surgery within the hospital stay.

What if a patient is admitted to critical care more than once during the follow-up period?

What if a patient is admitted to critical care more than once during the follow-up period?

The total number of critical care days are recorded if there are multiple critical care admissions following surgery within the hospital stay.

How is ‘days in hospital after surgery’ defined?

How is ‘days in hospital after surgery’ defined?

Duration of hospital stay is defined as time in days from the day of surgery to the day the patient leaves your hospital. This will not be adjusted for delays relating to provision of social care.

What about patients who are still in hospital many months after surgery?

What about patients who are still in hospital many months after surgery?

This will happen for a small number of patients. Because we need complete data returned quickly, we have decided to censor follow-up at thirty days. So all patients are followed until hospital discharge or for thirty days after surgery whichever is the shortest.

Where do I find the definitions of ‘Anaesthetic complications’ and for the complications listed under ‘Postoperative follow up’?

Where do I find the definitions of ‘Anaesthetic complications’ and for the complications listed under ‘Postoperative follow up’?

There is a full ‘Patient outcomes definition guide’ document which can be downloaded off this web site. It has the definitions for all outcomes and severity grades listed on the CRF.

What is the definition of ‘Critical care admission to treat postoperative complications’?

What is the definition of ‘Critical care admission to treat postoperative complications’?

Patients who have a postoperative complication and as a result are admitted to critical care, should have this marked as ‘Yes’.