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

This study has been terminated.
(Difficulties with recruitment)
Sponsor:
Information provided by (Responsible Party):
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01675466
First received: July 20, 2012
Last updated: March 24, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Non-specific Abdominal Pain
Procedure: early laparoscopy
Procedure: General anaesthesia
Device: Laparoscopic instruments
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial

Resource links provided by NLM:


Further study details as provided by Mid Western Regional Hospital, Ireland:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: the length of inpatient stay ] [ Designated as safety issue: Yes ]
    The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.


Secondary Outcome Measures:
  • Complications within 30 days [ Time Frame: within 30 days following randomisation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • SF36 score at 4 weeks [ Time Frame: from randomisation to4 weeks ] [ Designated as safety issue: No ]
    The Short Form (36) Health Survey is a validated survey of patient health

  • SF36 score at 6 months [ Time Frame: 6 months following randomisation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • further blood investigations during inpatient stay [ Time Frame: during inpatient stay ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This refers to further urine tests during hospital stay. The average hospital stay is expected to be 3 days.


Enrollment: 17
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: early laparoscopy
early laparoscopy, aiming to achieve this within 12 hours
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
Placebo Comparator: active observation
standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675466

Locations
Ireland
University Hospital Limerick
Limerick, Ireland
Sponsors and Collaborators
Mid Western Regional Hospital, Ireland
Investigators
Principal Investigator: Donagh A Healy, MB
Principal Investigator: Stewart R Walsh, MB MCh
  More Information

No publications provided

Responsible Party: Professor Stewart Walsh, Professor, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01675466     History of Changes
Other Study ID Numbers: ABC123
Study First Received: July 20, 2012
Last Updated: March 24, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by Mid Western Regional Hospital, Ireland:
non-specific abdominal pain
undifferentiated abdominal pain
appendicitis
appendicectomy
appendectomy
surgery
laparoscopy
antibiotics
randomised controlled trial
randomized controlled trial
controlled clinical trial
randomised
placebo

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 16, 2014