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

Primary Purpose

Non-specific Abdominal Pain

Status
Terminated
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
early laparoscopy
General anaesthesia
Laparoscopic instruments
Sponsored by
Mid Western Regional Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Abdominal Pain focused on measuring non-specific abdominal pain, undifferentiated abdominal pain, appendicitis, appendicectomy, appendectomy, surgery, laparoscopy, antibiotics, randomised controlled trial, randomized controlled trial, controlled clinical trial, randomised, placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Limerick

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

early laparoscopy

active observation

Arm Description

early laparoscopy, aiming to achieve this within 12 hours

standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary

Outcomes

Primary Outcome Measures

Length of hospital stay
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
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
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
SF36 score at 4 weeks
The Short Form (36) Health Survey is a validated survey of patient health
SF36 score at 6 months
The Short Form (36) Health Survey is a validated survey of patient health
upstaging to more severe diagnosis within 6 months
further blood investigations 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
This refers to further urine tests during hospital stay. The average hospital stay is expected to be 3 days.

Full Information

First Posted
July 20, 2012
Last Updated
March 24, 2013
Sponsor
Mid Western Regional Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01675466
Brief Title
Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain
Acronym
FLO
Official Title
First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with recruitment
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mid Western Regional Hospital, Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Abdominal Pain
Keywords
non-specific abdominal pain, undifferentiated abdominal pain, appendicitis, appendicectomy, appendectomy, surgery, laparoscopy, antibiotics, randomised controlled trial, randomized controlled trial, controlled clinical trial, randomised, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early laparoscopy
Arm Type
Active Comparator
Arm Description
early laparoscopy, aiming to achieve this within 12 hours
Arm Title
active observation
Arm Type
Placebo Comparator
Arm Description
standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary
Intervention Type
Procedure
Intervention Name(s)
early laparoscopy
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
General anaesthesia
Intervention Type
Device
Intervention Name(s)
Laparoscopic instruments
Other Intervention Name(s)
Laparoscopic camera, Maryland laparoscopic grasper, Endoclinch laparoscopic grasper, Endobag, Laparoscopic suction
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.
Time Frame
the length of inpatient stay
Secondary Outcome Measure Information:
Title
Complications within 30 days
Description
Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.
Time Frame
within 30 days following randomisation
Title
further radiological investigations 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.
Time Frame
during inpatient stay
Title
readmission to hospital with abdominal pain
Time Frame
from randomisation to 6 months
Title
SF36 score at 4 weeks
Description
The Short Form (36) Health Survey is a validated survey of patient health
Time Frame
from randomisation to4 weeks
Title
SF36 score at 6 months
Description
The Short Form (36) Health Survey is a validated survey of patient health
Time Frame
6 months following randomisation
Title
upstaging to more severe diagnosis within 6 months
Time Frame
from randomisation to 6 months
Title
further blood investigations 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
Time Frame
during inpatient stay
Title
further urine tests during inpatient stay
Description
This refers to further urine tests during hospital stay. The average hospital stay is expected to be 3 days.
Time Frame
during inpatient stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donagh A Healy, MB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stewart R Walsh, MB MCh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland

12. IPD Sharing Statement

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

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