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

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.

Study Overview

• Status: Terminated
• Conditions: Non-specific Abdominal Pain
• Intervention / Treatment: Procedure: early laparoscopy; Procedure: General anaesthesia; Device: Laparoscopic instruments

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: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland
    • University Hospital Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The primary outcome is the length of inpatient hospital stay which will an expected average of 3 days.	the length of inpatient stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications within 30 days	Includes any complication encountered by participants in either arm of the trial in the first 30 days following randomisation.	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.	during inpatient stay
readmission to hospital with abdominal pain		from randomisation to 6 months
SF36 score at 4 weeks	The Short Form (36) Health Survey is a validated survey of patient health	from randomisation to4 weeks
SF36 score at 6 months	The Short Form (36) Health Survey is a validated survey of patient health	6 months following randomisation
upstaging to more severe diagnosis within 6 months		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	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.	during inpatient stay

Collaborators and Investigators

• Sponsor: Mid Western Regional Hospital, Ireland
• Investigators: Principal Investigator: Donagh A Healy, MB; Principal Investigator: Stewart R Walsh, MB MCh

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 24, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: randomized controlled trial; surgery; placebo; laparoscopy; randomised controlled trial; appendicitis; antibiotics; controlled clinical trial; randomised; appendectomy; appendicectomy; non-specific abdominal pain; undifferentiated abdominal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ABC123 (Mansoura university)