Emergency High-risk Abdominal SurgeryNCT02124356
Functional Performance Following Emergency High-risk Abdominal Surgery
An observational study of Emergency High-risk Abdominal Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Emergency High-risk Abdominal Surgery
- What is being tested?
- Evaluation of functional performance
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Aug 2014
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (19 years and older) undergoing Emergency High-risk Abdominal Surgery at the Hvidovre University Hospital.
Who may be able to join
- Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).
Who cannot join
- Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)
Trial locations and contacts
1 site in 1 country.
About this study
Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. The hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.
- Conditions
- Emergency High-risk Abdominal Surgery
- Being tested
- Evaluation of functional performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of functional performanceOther
| Study group | Role | What they receive |
|---|---|---|
| Emergency High-risk Abdominal Surgery | Not described Receives: Other: Evaluation of functional performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic mobility evaluated by the Cumulated Ambulation Score (CAS)
Factors that limit independency in basic mobility will be evaluated on a daily basis.
Measured: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Secondary outcomes (3)
Physical activity assessment with accelerometer (ActivePAL)
Measured: Daily on postoperative day 1 to 7.
Visual Analog Scale (VAS)
VAS is a self-reported measure of pain intensity.
Measured: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Assessment of Motor and Process Skills (AMPS)
AMPS measures a person's performance capacity for activities of daily living (ADL) and/or independent living.
Measured: One time at postoperative day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency High-risk Abdominal SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Tange Kristensen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124356
- Sponsor's protocol ID
- HH-AHA-FYS-01
- Other IDs
- H-2-2014-FSP31
- Status last verified
- Oct 2014
- First submitted
- 23 Apr 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Performance Following Emergency High-risk Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02124356
- Acronym / sponsor ID
- HH-AHA-FYS-01
- Conditions
- Emergency High-risk Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Apr 2014 (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.
Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. The hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency High-risk Abdominal Surgery | – | Other: Evaluation of functional performance |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (19 years and older) undergoing Emergency High-risk Abdominal Surgery at the Hvidovre University Hospital.
Key inclusion criteria (1 listed)
- Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).
Key exclusion criteria (1 listed)
- Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)
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 |
|---|---|---|
| Evaluation of functional performance | Other | Emergency High-risk Abdominal Surgery |
Primary outcome
Basic mobility evaluated by the Cumulated Ambulation Score (CAS)
Time frame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Factors that limit independency in basic mobility will be evaluated on a daily basis.
3 secondary outcomes
Physical activity assessment with accelerometer (ActivePAL)
Time frame: Daily on postoperative day 1 to 7.
Visual Analog Scale (VAS)
Time frame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Assessment of Motor and Process Skills (AMPS)
Time frame: One time at postoperative day 4.
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 3 Oct 2014.
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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.
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?
An observational study of Emergency High-risk Abdominal Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 3 Oct 2014. 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 Denmark. 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?
Basic mobility evaluated by the Cumulated Ambulation Score (CAS) (time frame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).). 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 3 Oct 2014.