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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899885
First Posted: July 16, 2013
Last Update Posted: June 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Line Toft Tengberg, Hvidovre University Hospital
  Purpose

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 Intervention
Perforated Viscus Intestinal Obstruction Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized Course

Study Type: Interventional
Study Design: 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

Further study details as provided by Line Toft Tengberg, Hvidovre University Hospital:

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

Enrollment: 1200
Study Start Date: June 2013
Study Completion Date: June 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Line T Tengberg, MD Hvidovre University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Line Toft Tengberg, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01899885     History of Changes
Other Study ID Numbers: AHA-37855
First Submitted: July 4, 2013
First Posted: July 16, 2013
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:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases