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Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course (AHA)

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ClinicalTrials.gov Identifier: NCT01899885
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Line Toft Tengberg, Hvidovre University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Perforated Viscus Intestinal Obstruction Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized Course Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
Study Start Date : June 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: historic control group
Standard treatment in the historic control group
Active Comparator: Intervention group

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
 Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized Course

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


Outcome Measures
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Primary Outcome Measures :
  1. mortality rate [ Time Frame: Within 30 days of surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing primary emergency laparotomy or laparoscopy
  • patients undergoing reoperation after abdominal surgery.
  • Age > 18 years

Exclusion Criteria:

  • Appendectomy
  • Emergency laparoscopic cholecystectomy
  • Emergency diagnostic laparoscopy without intervention
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899885


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Line T Tengberg, MD Hvidovre University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Line Toft Tengberg, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01899885    
Other Study ID Numbers: AHA-37855
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Line Toft Tengberg, Hvidovre University Hospital:
Emergency laparotomy
Emergency laparoscopy
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases