Non-specific Abdominal PainPhase 4FLONCT01675466
Study Comparing Early Laparoscopy With Active Observation in Acute Non-specific Abdominal Pain
A Phase 4 study testing early laparoscopy, General anaesthesia and Laparoscopic instruments in people with Non-specific Abdominal Pain, run by Mid Western Regional Hospital, Ireland at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Abdominal Pain
- What is being tested?
- early laparoscopy, General anaesthesia and Laparoscopic instruments
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial
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.
Read the 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
- Conditions
- Non-specific Abdominal Pain
- Being tested
- early laparoscopy, General anaesthesia, Laparoscopic instruments
- 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
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early laparoscopyProcedure or surgery
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.
General anaesthesiaProcedure or surgery
Laparoscopic instrumentsDevice
Also called Laparoscopic camera, Maryland laparoscopic grasper, Endoclinch laparoscopic grasper, Endobag
| Study group | Role | What they receive |
|---|---|---|
| early laparoscopy | Active comparator | early laparoscopy, aiming to achieve this within 12 hours Receives: Procedure: early laparoscopy; Procedure: General anaesthesia; Device: Laparoscopic instruments |
| active observation | Placebo comparator | standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.
Measured: the length of inpatient stay
Secondary outcomes (8)
Complications within 30 days
Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.
Measured: within 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.
Measured: during inpatient stay
readmission to hospital with abdominal pain
Measured: from randomisation to 6 months
SF36 score at 4 weeks
The Short Form (36) Health Survey is a validated survey of patient health
Measured: from randomisation to4 weeks
SF36 score at 6 months
The Short Form (36) Health Survey is a validated survey of patient health
Measured: 6 months following randomisation
upstaging to more severe diagnosis within 6 months
Measured: from randomisation to 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
Measured: during inpatient stay
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.
Measured: during inpatient stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Difficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid Western Regional Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
- Investigators
- Donagh A Healy, MB, Principal investigatorStewart R Walsh, MB MCh, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675466
- Sponsor's protocol ID
- ABC123
- Acronym
- FLO
- Status last verified
- Mar 2013
- First submitted
- 20 Jul 2012
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Laparoscopy or Active Observation in Acute Non-specific Abdominal Pain: The FLO Trial
- ClinicalTrials.gov ID
- NCT01675466
- Acronym / sponsor ID
- FLO / ABC123
- Conditions
- Non-specific Abdominal Pain
- Keywords
- non-specific abdominal pain, undifferentiated abdominal pain, appendicitis, appendicectomy, appendectomy, surgery, laparoscopy, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mid Western Regional Hospital, IrelandUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early laparoscopy | Active comparator | Procedure: early laparoscopy, Procedure: General anaesthesia, Device: Laparoscopic instrumentsearly laparoscopy, aiming to achieve this within 12 hours |
| active observation | Placebo comparator | –standard management - the "wait and see" approach with serial examinations and investigations as deemed necessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early laparoscopyLaparoscopy 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 or surgery | early laparoscopy |
| General anaesthesia | Procedure or surgery | early laparoscopy |
| Laparoscopic instrumentsAlso: Laparoscopic camera, Maryland laparoscopic grasper, Endoclinch laparoscopic grasper, Endobag | Device | early laparoscopy |
Primary outcome
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.
8 secondary outcomes
Complications within 30 days
Time frame: within 30 days following randomisation
further radiological investigations during inpatient stay
Time frame: during inpatient stay
readmission to hospital with abdominal pain
Time frame: from randomisation to 6 months
SF36 score at 4 weeks
Time frame: from randomisation to4 weeks
SF36 score at 6 months
Time frame: 6 months following randomisation
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
further urine tests during inpatient stay
Time frame: during inpatient stay
Results and safety
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donagh A Healy, MB principal investigator
Stewart R Walsh, MB MCh principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing early laparoscopy, General anaesthesia and Laparoscopic instruments in people with Non-specific Abdominal Pain, run by Mid Western Regional Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: the length of inpatient stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013; AzTrials last refreshed its copy on 28 Oct 2026.