Perioperative, Enhanced RecoveryNCT02726412
PACU Stay After Lower Limb Revascularisation
An observational study of Perioperative, Enhanced Recovery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative, Enhanced Recovery
- What is being tested?
- Acute vs elective
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes every patients who undergo revascularisation surgery of one or both of lower extremeties to regain blood perfusion and relieve symptoms. The surgeries in question are for instance bypass, thrombectomy/embolectomy and thromboendarterectomy. The patients preoperative physical state for surgery will be registrered in detailed such as comorbidities, height, weight, bloodpressure and blood test results.
Who may be able to join
- Patients with symptoms of ischaemic lower extremities for instance intermittent claudication, resting leg pain, non-healing/gangrenouswounds and acute cold leg.
- Patients who underwent one or more of the following surgical procedure: PTA + TEA, TEA, bypass, thrombectomy, embolectomy, femoral-femoral crossover bypass, axillary-femoral bypass.
Who cannot join
- Only PTA intervention
- Only thrombolysis intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Mechanisms for Postoperative Function - Case of Lower Extremities Revascularisation
This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare the complications outcomes between acute and elective revascularisation surgery.
Read the detailed description
As above
- Conditions
- Perioperative, Enhanced Recovery
- Being tested
- Acute vs elective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute vs electiveProcedure or surgery
non-intverention study
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications assessed by aldrete score
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative, Enhanced RecoveryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726412
- Sponsor's protocol ID
- PACU revascularisation 2016
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Mechanisms for Postoperative Function - Case of Lower Extremities Revascularisation
- ClinicalTrials.gov ID
- NCT02726412
- Acronym / sponsor ID
- PACU revascularisation 2016
- Conditions
- Perioperative, Enhanced Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Apr 2016 (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.
This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare the complications outcomes between acute and elective revascularisation surgery.
Detailed description
As above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes every patients who undergo revascularisation surgery of one or both of lower extremeties to regain blood perfusion and relieve symptoms. The surgeries in question are for instance bypass, thrombectomy/embolectomy and thromboendarterectomy. The patients preoperative physical state for surgery will be registrered in detailed such as comorbidities, height, weight, bloodpressure and blood test results.
Key inclusion criteria (2 listed)
- Patients with symptoms of ischaemic lower extremities for instance intermittent claudication, resting leg pain, non-healing/gangrenouswounds and acute cold leg.
- Patients who underwent one or more of the following surgical procedure: PTA + TEA, TEA, bypass, thrombectomy, embolectomy, femoral-femoral crossover bypass, axillary-femoral bypass.
Key exclusion criteria (2 listed)
- Only PTA intervention
- Only thrombolysis 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 |
|---|---|---|
| Acute vs electivenon-intverention study | Procedure or surgery | – |
Primary outcome
Complications assessed by aldrete score
Time frame: up to 7 days
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 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Perioperative, Enhanced Recovery
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Not yet recruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingPhase 4
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate
Recruiting
ERAS Protocols in Breast Conserving Surgery
Breast Cancer, Postoperative Recovery
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.
Eske K Aasvang, DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Perioperative, Enhanced Recovery, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 2 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 26 Apr 2017. 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?
Complications assessed by aldrete score (time frame: up to 7 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 26 Apr 2017.