Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain
Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain
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
Inclusion Criteria:

 -  age greater than 18

 -  admission with abdominal pain for up to one week prior to admission deemed to be
 non-specific pain by senior surgical team member

 -  patient willing to give full informed consent for participation

 Exclusion Criteria:

 -  patients less than 18 years of age

 -  pain of greater than 7 days duration

 -  admission with abdominal pain in previous 6 months

 -  history of inflammatory bowel disease

 -  previous history of appendicectomy

 -  previous surgery rendering laparoscopy unsafe eg. multiple laparotomies

 -  history of intra-abdominal transplant including retroperitoneal renal allografting

 -  clinical picture necessitating immediate surgical procedure

 -  cases involving trauma

 -  patients who are unable or unwilling to give full informed consent