Non-specific Abdominal Pain Clinical Trial
Official title:
First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial
Patients with acute abdominal pain comprise a significant proportion of attendances at
emergency departments. These patients account for about a third of general surgical
admissions in a typical day. In some cases, the diagnosis is clear from baseline
investigations (for example in cases of pancreatitis). In other cases, the diagnosis remains
unclear but there are signs that necessitate urgent surgery (for example in cases of
appendicitis). A final group exists where no clear explanation for the pain is found and
where there are insufficient clinical signs to warrant surgery. These patients are said to
have "non specific abdominal pain" (NSAP) and present a management dilemma.
Traditionally such patients are managed with a strategy of active observation. Patients are
examined at regular intervals and may undergo imaging. In some cases, symptoms and signs
progress and surgery is needed while in other cases resolution may occur or a diagnosis may
be reached non-operatively allowing focused medical treatment. Recently, two alternative
strategies have emerged. Early cross-sectional imaging using CT scanning may identify
conditions whilst being non-invasive. This would allow diagnosis and treatment would follow.
The alternative strategy of early laparoscopy (key hole surgery) offers the possibility of
concomitant therapy, but is invasive.
The study hypothesis is that in patients with acute non-specific abdominal pain active
management with laparoscopy on admission will reduce hospital stay and costs when compared
to traditional active observation, without increasing complications.
Patients referred to the general surgical service will initially be managed as per routine
practice. They will be assessed by a member of the surgical house-staff, simple baseline
investigations (full blood count, serum amylase, C-reactive protein, plain radiography) will
be requested. Patients will then be reviewed by a registrar or consultant. At this point, a
proportion of patients will have clear indications for surgery e.g. free gas on an erect
chest x-ray or peritonitis. A further subgroup will be more appropriately managed by further
tests on an out-patient basis and these patients will be allowed home. Some patients will
have a clear diagnosis e.g. pancreatitis. Patients in each of these groups will be managed
according to the usual practice of the responsible consultant surgeon.
There is a final subgroup of patients who are the population of interest for this trial.
These are patients in whom no clear diagnosis or safe decision to operate or discharge is
possible. Such patients are usually admitted for a period of observation with further
investigations or interventions ordered as their clinical picture evolves.
These patients will then be randomly assigned to one of two management options: an active
observation arm (control) or early laparoscopy arm.
Active Observation: Patients randomised to this group will receive routine practice and will
serve as the trial control group. They will be reviewed regularly by the responsible
surgical team. Further investigations and interventions will be requested at the discretion
of the responsible team.
Early laparoscopy: Patients randomised to this group will be listed for a diagnostic
laparoscopy in the emergency theatre . The aim will be to undertake this procedure within 12
hours of randomisation. The procedure will be performed by the duty consultant surgeon or
his / her nominated deputy as is usual practice. Findings at laparoscopy which require
surgical intervention e.g. appendicitis will be treated as part of the same procedure as is
routine clinical practice.
Follow-up: Each patient will be followed-up on a daily basis by a member of the trial team
whilst an in-patient. Complications, further investigations and interventions, unplanned
critical care admissions, death, length of hospital stay and final discharge diagnosis will
all be recorded. Following discharge, each patient will be reviewed at four weeks and six
months. SF36 questionnaires will be completed at each of these visits. In addition, the
Hospital In-patient Episode database will be interrogated for further admissions to other
hospitals within six months of randomisation
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment