Clinical Trial: Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial

Brief Summary:

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.


Detailed Summary:

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
Sponsor: Mid Western Regional Hospital, Ireland

Current Primary Outcome: Length of hospital stay [ Time Frame: the length of inpatient stay ]

The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complications within 30 days [ Time Frame: within 30 days following randomisation ]
    Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.
  • further radiological investigations during inpatient stay [ Time Frame: during inpatient stay ]
    A secondary outcome measure is the number of radiological tests patients undergo during their inpatient stay following randomisation. These could be ultrasound, plain radiography, CT scanning, MRI scanning. Average inpatient stay is expected to be 3days.
  • readmission to hospital with abdominal pain [ Time Frame: from randomisation to 6 months ]
  • SF36 score at 4 weeks [ Time Frame: from randomisation to4 weeks ]
    The Short Form (36) Health Survey is a validated survey of patient health
  • SF36 score at 6 months [ Time Frame: 6 months following randomisation ]
    The Short Form (36) Health Survey is a validated survey of patient health
  • upstaging to more severe diagnosis within 6 months [ Time Frame: from randomisation to 6 months ]
  • further blood investigations during inpatient stay [ Time Frame: during inpatient stay ]
    This refers to the number of further investigations during hospital stay. Average length of stay is expected to be 3 days
  • further urine tests during inpatient stay [ Time Frame: during inpatient stay ]
    This refers to further urine tests during hospital stay. The average hospital stay is expected to be 3 days.


Original Secondary Outcome:

  • Complications within 30 days [ Time Frame: within 30 days following randomisation ]
    Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.
  • further investigations during inpatient stay [ Time Frame: during inpatient stay ]
    A secondary outcome measure is the number of investigations patients undergo during their inpatient stay following randomisation.Average inpatient stay is expected to be 3days.
  • readmission to hospital with abdominal pain [ Time Frame: from randomisation to 6 months ]
  • SF36 score at 4 weeks [ Time Frame: from randomisation to4 weeks ]
    The Short Form (36) Health Survey is a validated survey of patient health
  • SF36 score at 6 months [ Time Frame: 6 months following randomisation ]
    The Short Form (36) Health Survey is a validated survey of patient health
  • upstaging to more severe diagnosis within 6 months [ Time Frame: from randomisation to 6 months ]


Information By: Mid Western Regional Hospital, Ireland

Dates:
Date Received: July 20, 2012
Date Started: August 2012
Date Completion:
Last Updated: March 24, 2013
Last Verified: March 2013