Perforated ViscusAHANCT01899885
Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
A study testing AHA (Acute Highrisk Abdominalsurgery): Optimized Course in people with Perforated Viscus and Intestinal Obstruction, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The objective of this study is to implement an optimized perioperative course for patients undergoing acute high-risk abdominal surgery in order to improve the outcome. The optimized perioperative course consists of a number of interventions carried out before, during and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforated Viscus, Intestinal Obstruction
- What is being tested?
- AHA (Acute Highrisk Abdominalsurgery): Optimized Course
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Jun 2015
- 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
- patients undergoing primary emergency laparotomy or laparoscopy
- patients undergoing reoperation after abdominal surgery.
- Age > 18 years
Who cannot join
- Appendectomy
- Emergency laparoscopic cholecystectomy
- Emergency diagnostic laparoscopy without intervention
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to implement an optimized perioperative course for patients undergoing acute high-risk abdominal surgery in order to improve the outcome.
The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.
Read the detailed description
Emergency surgery is associated with high mortality rates, post-operative complications and prolonged duration of hospital admission. The investigators will implement a multidisciplinary optimized perioperative course consisting of a number of interventions carried out before, during and after surgery.
Hypothesis: An optimized perioperative course will reduce the 30-day mortality in emergency abdominal surgery patients.
The investigators will do a post-hoc analysis of the data registered.
- Conditions
- Perforated Viscus, Intestinal Obstruction
- Being tested
- AHA (Acute Highrisk Abdominalsurgery): Optimized Course
- Keywords
- Emergency laparotomy, Emergency laparoscopy
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHA (Acute Highrisk Abdominalsurgery): Optimized CourseProcedure or surgery
optimized course: Intervention before, during and after abdominal surgery.
Focus on fast track with multimodal standardized intervention:
- standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit)
- GDT-LiDCO fluid management pre-, per- and postoperative
- Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score
- Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively
| Study group | Role | What they receive |
|---|---|---|
| historic control group | No intervention | Standard treatment in the historic control group |
| Intervention group | Active comparator | AHA (Acute Highrisk Abdominalsurgery): Optimized Course:
Intervention before, during and after abdominal surgery.
Focus on fast track with multimodal standardized intervention:
1. standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit)
2. GDT-LiDCO fluid management pre-, per- and postoperative
3. Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score
4. Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively Receives: Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perforated ViscusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Line Toft Tengberg, Hvidovre University Hospital
- Investigators
- Line T Tengberg, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899885
- Sponsor's protocol ID
- AHA-37855
- Acronym
- AHA
- Status last verified
- Jun 2015
- First submitted
- 4 Jul 2013
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tengberg LT, Bay-Nielsen M, Bisgaard T, Cihoric M, Lauritsen ML, Foss NB; AHA study group. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery. Br J Surg. 2017 Mar;104(4):463-471. doi: 10.1002/bjs.10427. Epub 2017 Jan 23.
PubMed 28112798
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
- ClinicalTrials.gov ID
- NCT01899885
- Acronym / sponsor ID
- AHA / AHA-37855
- Conditions
- Perforated Viscus, Intestinal Obstruction
- Keywords
- Emergency laparotomy, Emergency laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jul 2013 (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 objective of this study is to implement an optimized perioperative course for patients undergoing acute high-risk abdominal surgery in order to improve the outcome.
The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.
Detailed description
Emergency surgery is associated with high mortality rates, post-operative complications and prolonged duration of hospital admission. The investigators will implement a multidisciplinary optimized perioperative course consisting of a number of interventions carried out before, during and after surgery.
Hypothesis: An optimized perioperative course will reduce the 30-day mortality in emergency abdominal surgery patients.
The investigators will do a post-hoc analysis of the data registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| historic control group | No intervention | –Standard treatment in the historic control group |
| Intervention group | Active comparator | Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized CourseAHA (Acute Highrisk Abdominalsurgery): Optimized Course: Intervention before, during and after abdominal surgery. Focus on fast track with multimodal standardized intervention: 1. standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit) 2. GDT-LiDCO fluid management pre-, per- and postoperative 3. Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score 4. Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing primary emergency laparotomy or laparoscopy
- patients undergoing reoperation after abdominal surgery.
- Age > 18 years
Key exclusion criteria (3 listed)
- Appendectomy
- Emergency laparoscopic cholecystectomy
- Emergency diagnostic laparoscopy 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 |
|---|---|---|
| AHA (Acute Highrisk Abdominalsurgery): Optimized Courseoptimized course: Intervention before, during and after abdominal surgery. Focus on fast track with multimodal standardized intervention: 1. standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit) 2. GDT-LiDCO fluid management pre-, per- and postoperative 3. Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score 4. Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively | Procedure or surgery | Intervention group |
Primary outcome
mortality rate
Time frame: Within 30 days of surgery
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 12 Jun 2015.
- Derived from this study: PubMed 28112798Tengberg LT, Bay-Nielsen M, Bisgaard T, Cihoric M, Lauritsen ML, Foss NB; AHA study group. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery. Br J Surg. 2017 Mar;104(4):463-471. doi: 10.1002/bjs.10427. Epub 2017 Jan 23.
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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.
Line T Tengberg, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHA (Acute Highrisk Abdominalsurgery): Optimized Course in people with Perforated Viscus and Intestinal Obstruction, 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 3 inclusion and 3 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 12 Jun 2015. 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?
mortality rate (time frame: Within 30 days of surgery). 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 NCT01899885, which also lists 1 linked publication.
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 12 Jun 2015.