<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675466</url>
  </required_header>
  <id_info>
    <org_study_id>ABC123</org_study_id>
    <nct_id>NCT01675466</nct_id>
  </id_info>
  <brief_title>Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain</brief_title>
  <acronym>FLO</acronym>
  <official_title>First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mid Western Regional Hospital, Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mid Western Regional Hospital, Ireland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute abdominal pain comprise a significant proportion of attendances at&#xD;
      emergency departments. These patients account for about a third of general surgical&#xD;
      admissions in a typical day. In some cases, the diagnosis is clear from baseline&#xD;
      investigations (for example in cases of pancreatitis). In other cases, the diagnosis remains&#xD;
      unclear but there are signs that necessitate urgent surgery (for example in cases of&#xD;
      appendicitis). A final group exists where no clear explanation for the pain is found and&#xD;
      where there are insufficient clinical signs to warrant surgery. These patients are said to&#xD;
      have &quot;non specific abdominal pain&quot; (NSAP) and present a management dilemma.&#xD;
&#xD;
      Traditionally such patients are managed with a strategy of active observation. Patients are&#xD;
      examined at regular intervals and may undergo imaging. In some cases, symptoms and signs&#xD;
      progress and surgery is needed while in other cases resolution may occur or a diagnosis may&#xD;
      be reached non-operatively allowing focused medical treatment. Recently, two alternative&#xD;
      strategies have emerged. Early cross-sectional imaging using CT scanning may identify&#xD;
      conditions whilst being non-invasive. This would allow diagnosis and treatment would follow.&#xD;
      The alternative strategy of early laparoscopy (key hole surgery) offers the possibility of&#xD;
      concomitant therapy, but is invasive.&#xD;
&#xD;
      The study hypothesis is that in patients with acute non-specific abdominal pain active&#xD;
      management with laparoscopy on admission will reduce hospital stay and costs when compared to&#xD;
      traditional active observation, without increasing complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients referred to the general surgical service will initially be managed as per routine&#xD;
      practice. They will be assessed by a member of the surgical house-staff, simple baseline&#xD;
      investigations (full blood count, serum amylase, C-reactive protein, plain radiography) will&#xD;
      be requested. Patients will then be reviewed by a registrar or consultant. At this point, a&#xD;
      proportion of patients will have clear indications for surgery e.g. free gas on an erect&#xD;
      chest x-ray or peritonitis. A further subgroup will be more appropriately managed by further&#xD;
      tests on an out-patient basis and these patients will be allowed home. Some patients will&#xD;
      have a clear diagnosis e.g. pancreatitis. Patients in each of these groups will be managed&#xD;
      according to the usual practice of the responsible consultant surgeon.&#xD;
&#xD;
      There is a final subgroup of patients who are the population of interest for this trial.&#xD;
      These are patients in whom no clear diagnosis or safe decision to operate or discharge is&#xD;
      possible. Such patients are usually admitted for a period of observation with further&#xD;
      investigations or interventions ordered as their clinical picture evolves.&#xD;
&#xD;
      These patients will then be randomly assigned to one of two management options: an active&#xD;
      observation arm (control) or early laparoscopy arm.&#xD;
&#xD;
      Active Observation: Patients randomised to this group will receive routine practice and will&#xD;
      serve as the trial control group. They will be reviewed regularly by the responsible surgical&#xD;
      team. Further investigations and interventions will be requested at the discretion of the&#xD;
      responsible team.&#xD;
&#xD;
      Early laparoscopy: Patients randomised to this group will be listed for a diagnostic&#xD;
      laparoscopy in the emergency theatre . The aim will be to undertake this procedure within 12&#xD;
      hours of randomisation. The procedure will be performed by the duty consultant surgeon or his&#xD;
      / her nominated deputy as is usual practice. Findings at laparoscopy which require surgical&#xD;
      intervention e.g. appendicitis will be treated as part of the same procedure as is routine&#xD;
      clinical practice.&#xD;
&#xD;
      Follow-up: Each patient will be followed-up on a daily basis by a member of the trial team&#xD;
      whilst an in-patient. Complications, further investigations and interventions, unplanned&#xD;
      critical care admissions, death, length of hospital stay and final discharge diagnosis will&#xD;
      all be recorded. Following discharge, each patient will be reviewed at four weeks and six&#xD;
      months. SF36 questionnaires will be completed at each of these visits. In addition, the&#xD;
      Hospital In-patient Episode database will be interrogated for further admissions to other&#xD;
      hospitals within six months of randomisation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulties with recruitment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>the length of inpatient stay</time_frame>
    <description>The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications within 30 days</measure>
    <time_frame>within 30 days following randomisation</time_frame>
    <description>Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>further radiological investigations during inpatient stay</measure>
    <time_frame>during inpatient stay</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>readmission to hospital with abdominal pain</measure>
    <time_frame>from randomisation to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF36 score at 4 weeks</measure>
    <time_frame>from randomisation to4 weeks</time_frame>
    <description>The Short Form (36) Health Survey is a validated survey of patient health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF36 score at 6 months</measure>
    <time_frame>6 months following randomisation</time_frame>
    <description>The Short Form (36) Health Survey is a validated survey of patient health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>upstaging to more severe diagnosis within 6 months</measure>
    <time_frame>from randomisation to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>further blood investigations during inpatient stay</measure>
    <time_frame>during inpatient stay</time_frame>
    <description>This refers to the number of further investigations during hospital stay. Average length of stay is expected to be 3 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>further urine tests during inpatient stay</measure>
    <time_frame>during inpatient stay</time_frame>
    <description>This refers to further urine tests during hospital stay. The average hospital stay is expected to be 3 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Non-specific Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>early laparoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>early laparoscopy, aiming to achieve this within 12 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active observation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>standard management - the &quot;wait and see&quot; approach with serial examinations and investigations as deemed necessary</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>early laparoscopy</intervention_name>
    <description>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.</description>
    <arm_group_label>early laparoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anaesthesia</intervention_name>
    <arm_group_label>early laparoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laparoscopic instruments</intervention_name>
    <arm_group_label>early laparoscopy</arm_group_label>
    <other_name>Laparoscopic camera</other_name>
    <other_name>Maryland laparoscopic grasper</other_name>
    <other_name>Endoclinch laparoscopic grasper</other_name>
    <other_name>Endobag</other_name>
    <other_name>Laparoscopic suction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age greater than 18&#xD;
&#xD;
          -  admission with abdominal pain for up to one week prior to admission deemed to be&#xD;
             non-specific pain by senior surgical team member&#xD;
&#xD;
          -  patient willing to give full informed consent for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients less than 18 years of age&#xD;
&#xD;
          -  pain of greater than 7 days duration&#xD;
&#xD;
          -  admission with abdominal pain in previous 6 months&#xD;
&#xD;
          -  history of inflammatory bowel disease&#xD;
&#xD;
          -  previous history of appendicectomy&#xD;
&#xD;
          -  previous surgery rendering laparoscopy unsafe eg. multiple laparotomies&#xD;
&#xD;
          -  history of intra-abdominal transplant including retroperitoneal renal allografting&#xD;
&#xD;
          -  clinical picture necessitating immediate surgical procedure&#xD;
&#xD;
          -  cases involving trauma&#xD;
&#xD;
          -  patients who are unable or unwilling to give full informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donagh A Healy, MB</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Stewart R Walsh, MB MCh</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Limerick</name>
      <address>
        <city>Limerick</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>March 24, 2013</last_update_submitted>
  <last_update_submitted_qc>March 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mid Western Regional Hospital, Ireland</investigator_affiliation>
    <investigator_full_name>Professor Stewart Walsh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>non-specific abdominal pain</keyword>
  <keyword>undifferentiated abdominal pain</keyword>
  <keyword>appendicitis</keyword>
  <keyword>appendicectomy</keyword>
  <keyword>appendectomy</keyword>
  <keyword>surgery</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>antibiotics</keyword>
  <keyword>randomised controlled trial</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>controlled clinical trial</keyword>
  <keyword>randomised</keyword>
  <keyword>placebo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675466
org study id: ABC123
nct id: NCT01675466
lead sponsor: 
has dmc: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of hospital stay
time frame: the length of inpatient stay
description: The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.
measure: Complications within 30 days
time frame: within 30 days following randomisation
description: Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.
measure: further radiological investigations during inpatient stay
time frame: during inpatient stay
description: 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.
measure: readmission to hospital with abdominal pain
time frame: from randomisation to 6 months
measure: SF36 score at 4 weeks
time frame: from randomisation to4 weeks
description: The Short Form (36) Health Survey is a validated survey of patient health
measure: SF36 score at 6 months
time frame: 6 months following randomisation
description: The Short Form (36) Health Survey is a validated survey of patient health
measure: upstaging to more severe diagnosis within 6 months
time frame: from randomisation to 6 months
measure: further blood investigations during inpatient stay
time frame: during inpatient stay
description: This refers to the number of further investigations during hospital stay. Average length of stay is expected to be 3 days
measure: further urine tests during inpatient stay
time frame: during inpatient stay
description: This refers to further urine tests during hospital stay. The average hospital stay is expected to be 3 days.
arm group label: early laparoscopy
arm group type: Active Comparator
description: early laparoscopy, aiming to achieve this within 12 hours
arm group label: active observation
arm group type: Placebo Comparator
description: standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary
intervention type: Procedure
intervention name: early laparoscopy
description: 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.
arm group label: early laparoscopy
intervention type: Procedure
intervention name: General anaesthesia
arm group label: early laparoscopy
intervention type: Device
intervention name: Laparoscopic instruments
arm group label: early laparoscopy
other name: Laparoscopic camera
other name: Maryland laparoscopic grasper
other name: Endoclinch laparoscopic grasper
other name: Endobag
other name: Laparoscopic suction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donagh A Healy, MB
role: Principal Investigator
last name: Stewart R Walsh, MB MCh
role: Principal Investigator
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Mid Western Regional Hospital, Ireland
investigator full name: Professor Stewart Walsh
investigator title: Professor
mesh term: Abdominal Pain
mesh term: Anesthetics