Abdominal PainNCT05402774
Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department
A study testing point-of-care ultrasound in people with Abdominal Pain, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Background: Abdominal pain is one of the most common reasons for admission to the emergency department (ED). This study aimed to investigate the effect of point-of-care ultrasound (POCUS) performed during the initial evaluation phase of patients who presented to the ED with abdominal pain on diagnostic processes… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- point-of-care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years
- Patients who presented to the ED with abdominal pain
- Nontraumatic patients
Who cannot join
- permanent mental disability,
- age <18 years,
- abdominal trauma within the last 24 hours,
- pregnancy, morbid obesity, repeated admissions,
- referral from an external center to the ED,
- missing patient information.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54050
About this study
Official title: Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department: a Randomized, Prospective, Controlled Study
Background: Abdominal pain is one of the most common reasons for admission to the emergency department (ED). This study aimed to investigate the effect of point-of-care ultrasound (POCUS) performed during the initial evaluation phase of patients who presented to the ED with abdominal pain on diagnostic processes, length of stay (LOS) in ED, and hospitalization and healthcare costs.
Methodology: This prospective, randomized, controlled, parallel group study was conducted with patients who presented to the Sakarya Education Research Hospital ED with abdominal pain from October 2019 to March 2020. Patients were divided randomly into two groups: control group where standard diagnostic strategies were applied and the POCUS group where POCUS was performed together with standard diagnostic strategies. All data were analyzed using IBM SPSS 21.
- Conditions
- Abdominal Pain
- Being tested
- point-of-care ultrasound
- Keywords
- Abdominal pain, Cost, Emergency department, Length of stay, point-of-care ultrasound
- 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.
point-of-care ultrasoundDiagnostic test
point-of-care ultrasound
| Study group | Role | What they receive |
|---|---|---|
| point-of-care ultrasound group | Other | Not described Receives: Diagnostic Test: point-of-care ultrasound |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the effect of POCUS on the Length of stay in emergency department
Measured: 6 months
Secondary outcomes (1)
to measure the effect of POCUS on the average cost of patients, the rate of change in the preliminary diagnosis of the physician, and hospitalization and discharge rate
Measured: 1 months after discharge or hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Oct 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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 Sakarya UniversityThe 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
- Model description
- a randomized, prospective, controlled study
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necip Gökhan Güner, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402774
- Sponsor's protocol ID
- 16214662/050.01.04/152
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.
PubMed 24998674Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.
PubMed 33397050
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Pain Management and Point-of-care Ultrasound in the Emergency Department: a Randomized, Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT05402774
- Acronym / sponsor ID
- 16214662/050.01.04/152
- Conditions
- Abdominal Pain
- Keywords
- Abdominal pain, Cost, Emergency department, Length of stay, point-of-care ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 Jun 2022 (actual)
- 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.
Background: Abdominal pain is one of the most common reasons for admission to the emergency department (ED). This study aimed to investigate the effect of point-of-care ultrasound (POCUS) performed during the initial evaluation phase of patients who presented to the ED with abdominal pain on diagnostic processes, length of stay (LOS) in ED, and hospitalization and healthcare costs.
Methodology: This prospective, randomized, controlled, parallel group study was conducted with patients who presented to the Sakarya Education Research Hospital ED with abdominal pain from October 2019 to March 2020. Patients were divided randomly into two groups: control group where standard diagnostic strategies were applied and the POCUS group where POCUS was performed together with standard diagnostic strategies. All data were analyzed using IBM SPSS 21.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- a randomized, prospective, controlled study
| Arm | Type | Receives |
|---|---|---|
| point-of-care ultrasound group | Other | Diagnostic Test: point-of-care ultrasound |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18 years
- Patients who presented to the ED with abdominal pain
- Nontraumatic patients
Key exclusion criteria (6 listed)
- permanent mental disability,
- age <18 years,
- abdominal trauma within the last 24 hours,
- pregnancy, morbid obesity, repeated admissions,
- referral from an external center to the ED,
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 |
|---|---|---|
| point-of-care ultrasoundpoint-of-care ultrasound | Diagnostic test | point-of-care ultrasound group |
Primary outcome
to measure the effect of POCUS on the Length of stay in emergency department
Time frame: 6 months
1 secondary outcome
to measure the effect of POCUS on the average cost of patients, the rate of change in the preliminary diagnosis of the physician, and hospitalization and discharge rate
Time frame: 1 months after discharge or hospitalisation
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 2 Jun 2022.
- Background: PubMed 24998674Laursen CB, Sloth E, Lassen AT, Christensen Rd, Lambrechtsen J, Madsen PH, Henriksen DP, Davidsen JR, Rasmussen F. Point-of-care ultrasonography in patients admitted with respiratory symptoms: a single-blind, randomised controlled trial. Lancet Respir Med. 2014 Aug;2(8):638-46. doi: 10.1016/S2213-2600(14)70135-3. Epub 2014 Jul 3.
- Results publication: PubMed 33397050Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.
- Individual participant dataSharing planned: No
Related trials for Abdominal Pain
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing point-of-care ultrasound in people with Abdominal Pain, run by Sakarya University at 1 site in Turkey (Türkiye).
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 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 2 Jun 2022. 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 Turkey (Türkiye). 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. 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?
to measure the effect of POCUS on the Length of stay in emergency department (time frame: 6 months). 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 NCT05402774, 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 2 Jun 2022.