Abdominal PainNCT00550511
Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
A study testing Surgeon-performed ultrasound in people with Abdominal Pain, run by Karolinska Institutet.
Trial summary
The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement to clinical investigation when a patient presents with abdominal pain in the emergency department can improve the management of the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Surgeon-performed ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Jun 2005
- Phase
- Interventional
- 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
- Admitted to emergency ward for abdominal pain
- 18 years or older
Who cannot join
- Pregnancy
- Condition that has to be taken care of immediately
- Inability to communicate with the investigator
- Previously diagnosed abdominal condition
- Severe drug or alcohol addiction
- Dementia
About this study
The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement to clinical investigation when a patient presents with abdominal pain in the emergency department can improve the management of the patient.
Read the detailed description
Surgeon-performed ultrasound bedside in the emergency department when a patient presents with abdominal pain is quite common in Continental Europe and USA. It is considered to be implemented at emergency departments all over Sweden. This is the first randomized study performed to evaluate the method. In our study we compare diagnostic accuracy and further management of patients admitted to the emergency department for abdominal pain, with or without examination with surgeon-performed ultrasound bedside.
- Conditions
- Abdominal Pain
- Being tested
- Surgeon-performed ultrasound
- Keywords
- Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy
- Medical subject headings
- Abdominal Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon-performed ultrasoundRadiation
Also called US
After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Other | Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing. Receives: Radiation: Surgeon-performed ultrasound |
| Control | No intervention | Control group examined with clinical examination including standardized laboratory tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of correct diagnosis
Measured: 6 weeks
Secondary outcomes (1)
Time consumption in emergency department Time to decision about surgical intervention Amount of complementary examinations Amount of hospital admissions Patient satisfaction in the emergency ward and at follow up Consumption of health care
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startFeb 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Investigators
- Johanna Adami, ass prof, Principal investigator, Karolinska Institutet, Department of Medicine, Clinical epidemiology unitAnna Lindelius, MD, Study director, Karolinska Institutet, Department of Surgery, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550511
- Sponsor's protocol ID
- ULABD-1
- Status last verified
- Oct 2007
- First submitted
- 29 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindelius A, Torngren S, Nilsson L, Pettersson H, Adami J. Randomized clinical trial of bedside ultrasound among patients with abdominal pain in the emergency department: impact on patient satisfaction and health care consumption. Scand J Trauma Resusc Emerg Med. 2009 Nov 27;17:60. doi: 10.1186/1757-7241-17-60.
PubMed 19941671Lindelius A, Torngren S, Pettersson H, Adami J. Role of surgeon-performed ultrasound on further management of patients with acute abdominal pain: a randomised controlled clinical trial. Emerg Med J. 2009 Aug;26(8):561-6. doi: 10.1136/emj.2008.062067.
PubMed 19625549
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
- ClinicalTrials.gov ID
- NCT00550511
- Acronym / sponsor ID
- ULABD-1
- Conditions
- Abdominal Pain
- Keywords
- Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Feb 2004
- Study completion
- Jun 2005 (actual)
- First posted
- 30 Oct 2007 (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.
The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement to clinical investigation when a patient presents with abdominal pain in the emergency department can improve the management of the patient.
Detailed description
Surgeon-performed ultrasound bedside in the emergency department when a patient presents with abdominal pain is quite common in Continental Europe and USA. It is considered to be implemented at emergency departments all over Sweden. This is the first randomized study performed to evaluate the method. In our study we compare diagnostic accuracy and further management of patients admitted to the emergency department for abdominal pain, with or without examination with surgeon-performed ultrasound bedside.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Other | Radiation: Surgeon-performed ultrasoundSurgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing. |
| Control | No intervention | –Control group examined with clinical examination including standardized laboratory tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to emergency ward for abdominal pain
- 18 years or older
Key exclusion criteria (6 listed)
- Pregnancy
- Condition that has to be taken care of immediately
- Inability to communicate with the investigator
- Previously diagnosed abdominal condition
- Severe drug or alcohol addiction
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 |
|---|---|---|
| Surgeon-performed ultrasoundAlso: USAfter clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon. | Radiation | Ultrasound |
Primary outcome
Proportion of correct diagnosis
Time frame: 6 weeks
1 secondary outcome
Time consumption in emergency department Time to decision about surgical intervention Amount of complementary examinations Amount of hospital admissions Patient satisfaction in the emergency ward and at follow up Consumption of health care
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
- Derived from this study: PubMed 19941671Lindelius A, Torngren S, Nilsson L, Pettersson H, Adami J. Randomized clinical trial of bedside ultrasound among patients with abdominal pain in the emergency department: impact on patient satisfaction and health care consumption. Scand J Trauma Resusc Emerg Med. 2009 Nov 27;17:60. doi: 10.1186/1757-7241-17-60.
- Derived from this study: PubMed 19625549Lindelius A, Torngren S, Pettersson H, Adami J. Role of surgeon-performed ultrasound on further management of patients with acute abdominal pain: a randomised controlled clinical trial. Emerg Med J. 2009 Aug;26(8):561-6. doi: 10.1136/emj.2008.062067.
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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.
Johanna Adami, ass prof principal investigator
Karolinska Institutet, Department of Medicine, Clinical epidemiology unit
Anna Lindelius, MD study director
Karolinska Institutet, Department of Surgery, Stockholm South General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Surgeon-performed ultrasound in people with Abdominal Pain, run by Karolinska Institutet.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of correct diagnosis (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00550511, which also lists 2 linked publications.
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 30 Oct 2007.