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Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain (FLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675466
Recruitment Status : Terminated (Difficulties with recruitment)
First Posted : August 30, 2012
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE August 30, 2012
Last Update Posted Date March 26, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
  • 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 Measures  ICMJE
 (submitted: August 27, 2012)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain
Official Title  ICMJE 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 Description

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-specific Abdominal Pain
Intervention  ICMJE
  • Procedure: early laparoscopy
    Laparoscopy under performed by the surgeon on duty or his/her deputy. The aim is to achieve this within 12 hours of randomisation. This will be performed under general anaesthetic and involve the necessary drugs. The procedure will require laparoscopy instruments. There will be a umbilical port which will be 10mm in size and one 5mm port below this. If pathology is found, a further port will be needed to perform treatment.
  • Procedure: General anaesthesia
  • Device: Laparoscopic instruments
    Other Names:
    • Laparoscopic camera
    • Maryland laparoscopic grasper
    • Endoclinch laparoscopic grasper
    • Endobag
    • Laparoscopic suction
Study Arms  ICMJE
  • Active Comparator: early laparoscopy
    early laparoscopy, aiming to achieve this within 12 hours
    Interventions:
    • Procedure: early laparoscopy
    • Procedure: General anaesthesia
    • Device: Laparoscopic instruments
  • Placebo Comparator: active observation
    standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 24, 2013)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2012)
400
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01675466
Other Study ID Numbers  ICMJE ABC123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
Study Sponsor  ICMJE Mid Western Regional Hospital, Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donagh A Healy, MB
Principal Investigator: Stewart R Walsh, MB MCh
PRS Account Mid Western Regional Hospital, Ireland
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP