An interventional study of Emergency Medicine Initial Assessment and Standard Surgical Assessment in Abdominal Pain (AP), Acute Abdomen and Acute Abdominal Pain, sponsored by Haukeland University Hospital. Not yet recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Health services research
The goal of this clinical trial is to learn whether initial assessment by a physician specializing in emergency medicine can improve the care of adults who come to the emergency department with acute abdominal pain or another undifferentiated acute abdominal condition and are referred for surgical assessment.
The main questions it aims to answer are:
Does initial assessment by an emergency medicine physician reduce the time patients spend in the emergency department? Is this model of care as safe as standard surgical assessment, including the risk of readmission and death within 30 days?
Researchers will compare patients who receive their initial assessment from an experienced emergency medicine physician with patients who receive standard care, where the initial assessment is usually performed by a junior surgical physician.
Participants will:
Be randomly assigned to one of the two models of initial assessment Receive diagnostic tests and treatment according to usual clinical practice Be followed for outcomes such as use of diagnostic imaging, treatment, hospital stay, readmission, and mortality Be asked to complete a short questionnaire about their experience in the emergency department
The study does not involve experimental drugs, devices, or procedures. The intervention changes which type of physician is responsible for the initial assessment and management in the emergency department.
This is a single-center, pragmatic, individually randomized, open-label, controlled clinical trial conducted in the emergency department at Haukeland University Hospital, Bergen, Norway. The study evaluates an alternative model for the initial assessment and management of adult patients presenting with undifferentiated acute abdominal conditions who are referred for gastrointestinal surgical assessment.
In current practice, these patients are usually initially assessed by a junior physician working in the surgical service. Diagnostic evaluation and treatment are subsequently discussed with more experienced surgical physicians as needed. This model may require several sequential assessments and may contribute to prolonged emergency department length of stay.
Emergency medicine was established as a medical specialty in Norway in 2019. Physicians specializing in emergency medicine are trained to assess a broad range of undifferentiated acute conditions, initiate diagnostic investigations and treatment, determine the appropriate level of care, and coordinate involvement of other specialties. However, there is limited evidence from Norwegian emergency departments regarding how the use of experienced emergency medicine physicians for the initial management of patients traditionally referred directly to surgical specialties affects patient flow, resource use, and safety.
The study therefore compares two models of initial care. In the intervention group, an experienced physician from the Department of Emergency Medicine, either a senior resident or consultant in emergency medicine, has primary responsibility for the initial assessment and management of the patient in the emergency department. This includes clinical assessment, selection and prioritization of laboratory and imaging investigations, initiation of treatment, and decisions regarding further disposition. Gastrointestinal surgeons or other relevant specialists are involved whenever clinically indicated.
In the control group, patients receive usual care according to the existing surgical admission pathway. The first medical assessment is usually performed by a junior physician working in the surgical service, with involvement of more experienced surgical physicians according to standard clinical routines.
The intervention does not introduce experimental diagnostic tests, medications, devices, or invasive procedures. Diagnostic investigations and treatment in both groups are performed according to usual clinical practice and applicable local and national guidelines. The difference between the study groups is primarily which physician group has responsibility for the initial assessment and coordination of care.
Participants are randomized in a 1:1 ratio using an electronic randomization system. Variable block sizes are used to maintain balance while limiting predictability of allocation. Because of the nature of the intervention, treating physicians and participants cannot be blinded to treatment allocation. Key study data are obtained from routinely collected electronic health record information where possible. Assessment of diagnostic agreement is planned to be performed by reviewers who are blinded to treatment allocation.
The primary analysis will follow the intention-to-treat principle. Participants will therefore be analyzed according to their assigned group regardless of subsequent changes in clinical responsibility or whether the final diagnosis is gastrointestinal surgical. Crossovers between the two models of care will be recorded, and a per-protocol analysis is planned as a sensitivity analysis.
The study is designed as a pragmatic evaluation of a change in the organization of emergency care. It is intended to determine whether assigning experienced emergency medicine physicians to the initial management of this patient population can improve emergency department efficiency while maintaining patient safety and appropriate use of diagnostic and therapeutic resources.
Because the intervention concerns organization of routine clinical care rather than an experimental treatment, the study is considered to involve low additional risk. Safety is monitored throughout the study. An independent Data Monitoring Committee reviews predefined safety information and may recommend continuation of the study, modification of study procedures or safety measures, temporary suspension of recruitment, or termination of the study if clinically important safety concerns arise. A planned interim safety review will be conducted after approximately 200 participants have been enrolled. Serious unexpected patient harm that may be related to the model of care will be reviewed independently irrespective of the timing of the planned safety review.
65 studies on the registry are indexed under Abdomen, Acute; 14 are open to participants now.
This study's planned enrollment of 440 is above the median of 188 across 26 interventional studies indexed under Abdomen, Acute.
Browse Abdomen, Acute studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Compared within Abdomen, Acute, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Abdominal Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥18 years
Exclusion Criteria:
Age \<18 years
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive their initial assessment and management in the emergency department from an experienced emergency medicine physician (senior resident or consultant in emergency medicine). The emergency medicine physician will have primary responsibility for the initial clinical assessment, diagnostic work-up, initiation of treatment, and decisions regarding further disposition. Gastrointestinal surgeons or other relevant specialists will be involved when clinically indicated.
Other: Emergency Medicine Initial Assessment
Participants randomized to this arm will receive standard care according to the existing surgical admission pathway. The initial medical assessment will usually be performed by a junior physician working in the surgical service, with diagnostic evaluation and treatment conducted according to usual clinical practice. More experienced surgical physicians will be involved according to standard routines and clinical need.
Other: Standard Surgical Assessment
Initial assessment and management in the emergency department by an experienced emergency medicine physician (senior resident or consultant in emergency medicine), including clinical assessment, selection and prioritization of diagnostic investigations, initiation of treatment, and decisions regarding further disposition. Surgical or other specialist input is obtained when clinically indicated.
Standard care according to the existing surgical admission pathway. The initial medical assessment will usually be performed by a junior physician working in the surgical service, with diagnostic evaluation and treatment conducted according to usual clinical practice. More experienced surgical physicians will be involved according to standard routines and clinical need.
Emergency Department Length of Stay
Emergency department length of stay, measured in minutes from the participant's registered arrival at the emergency department to registered departure from the emergency department. Departure is defined as transfer to an inpatient ward, operating room, or another department, or discharge directly from the emergency department. For participants who die in the emergency department, the time of death will be used as the departure time. Times will be obtained from electronic timestamps in the hospital electronic health record.
Time frame: From registered arrival at the emergency department until departure from the emergency department, assessed up to 48 hours.
Tentative Diagnosis Documented
Proportion of participants with a tentative diagnosis documented in the admission note.
Time frame: Within 48 hours of emergency department arrival.
Diagnostic Agreement
Agreement between the tentative diagnosis documented and validated in the admission note within 48 hours of emergency department arrival and the final principal discharge diagnosis from the index hospitalization.
Time frame: From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.
Use of Computed Tomography
Proportion of participants undergoing computed tomography during the first hospital day.
Time frame: Within the first 24 hours of the index hospitalization
Use of Ultrasound
Proportion of participants undergoing ultrasound performed by the radiology department during the first hospital day.
Time frame: Within the first 24 hours of the index hospitalization
Assessment by a More Experienced Surgical Physician
Proportion of participants assessed in the emergency department by a senior surgical resident or surgical consultant in addition to the initial assessing physician as documented in the physisians note.
Time frame: From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.
Antibiotic Treatment
Proportion of participants receiving systemic antibiotic treatment during the index hospitalization.
Time frame: From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.
Antibiotic Treatment Concordant With National Guidelines
Among participants receiving antibiotics, the proportion receiving an antimicrobial agent consistent with applicable national treatment guidelines. Assessment concerns choice of antimicrobial agent and does not include dose.
Time frame: From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.
Invasive Abdominal Intervention
Proportion of participants undergoing at least one therapeutic invasive abdominal intervention, including surgery, image-guided intervention, or therapeutic endoscopic intervention such as ERCP related to the acute condition.
Time frame: From emergency department arrival through 30 days after arrival.
Admission to a Gastrointestinal Surgical Ward
Proportion of participants admitted from the emergency department to a gastrointestinal surgical inpatient ward.
Time frame: From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.
Non-Gastrointestinal Surgical Condition Admitted to a Gastrointestinal Surgical Ward
Proportion of participants dispositioned from the emergency department to a gastrointestinal surgical inpatient ward who have a final principal diagnosis outside the gastrointestinal surgical specialty, receive predominantly non-surgical treatment, and do not undergo surgery during the index hospitalization.
Time frame: From emergency department arrival until discharge from the index hospitalization, assessed up to 30 days after arrival.
30-Day Readmission
Proportion of participants with at least one unplanned acute hospital readmission within 30 days after discharge from the index hospitalization.
Time frame: Within 30 days after discharge from the index hospitalization
30-Day All-Cause Mortality
Proportion of participants who die from any cause within 30 days after Emergency Department presentation.
Time frame: Within 30 days after ED presentation
Time From Emergency Department Arrival to Completion of Initial Medical Assessment
Time in minutes from registered arrival at the emergency department until the treating physician is registered as having completed the initial assessment in the electronic emergency department system.
Time frame: From emergency department arrival until completion of the initial medical assessment, assessed up to 48 hours after arrival.
Time to First Antibiotic Dose
Among participants receiving antibiotics in the emergency department, time in minutes from emergency department arrival to actual administration of the first antibiotic dose.
Time frame: From emergency department arrival until departure from the emergency department, assessed up to 48 hours after arrival.
Duration of Antibiotic Treatment
Total duration of antibiotic treatment, including planned treatment continuing after hospital discharge.
Time frame: From initiation of antibiotic treatment until completion of the treatment course, assessed up to 30 days after emergency department arrival.
Time to First Relevant Diagnostic Imaging
Time in minutes from emergency department arrival to completion of the first relevant computed tomography or ultrasound examination.
Time frame: From emergency department arrival until completion of the first relevant diagnostic imaging examination during the index hospitalization, assessed up to 30 days after arrival.
Time to Surgery
Among participants undergoing surgery for the acute abdominal condition during the index hospitalization, time in minutes from registered emergency department arrival to start of anesthesia.
Time frame: From emergency department arrival until start of anesthesia for surgery during the index hospitalization, assessed up to 30 days after arrival.
Time to Invasive Intervention
For patients that undergo an invasive intervention: Time in minutes from emergency department arrival to the start of the first relevant invasive intervention, including surgery, ERCP, or percutaneous image-guided intervention.
Time frame: From emergency department arrival until start of the first relevant invasive intervention during the index hospitalization, assessed up to 30 days after arrival.
Total Hospital Length of Stay
Duration of the index hospitalization, measured from emergency department arrival to hospital discharge.
Time frame: From emergency department arrival until discharge from the index hospitalization, assessed up to 90 days after arrival.
Overall Patient Satisfaction
Overall satisfaction with emergency department care measured using a single 1-to-5 Likert-scale question, with higher scores indicating greater satisfaction.
Time frame: Assessed at emergency department departure or within 48 hours after departure.
Days in Hospital Within 30 Days After Emergency Department Presentation
Cumulative number of days spent in hospital during the 30 days following the index emergency department presentation, including the index hospitalization and any unplanned revisits or readmissions resulting in hospital admission.
Time frame: From the index emergency department presentation through 30 days after presentation.
Patient Experience Score
Mean score from Likert-scale questions assessing communication and involvement during the emergency department stay. Higher scores indicate a better patient experience.
Time frame: Assessed at emergency department departure or within 48 hours after departure.
Plan to share: No — Individual participant data will not be made publicly available because the study uses sensitive health information collected from electronic health records, and data sharing is subject to Norwegian data protection regulations, ethics approval, participant consent, and institutional data governance requirements.
Start is estimated for Sep 2026; primary completion for Feb 2027, 4 months later.
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