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

This study is currently recruiting participants.
Verified July 2013 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Line Toft Tengberg, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01899885
First received: July 4, 2013
Last updated: July 15, 2013
Last verified: July 2013
  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: Open Label
Primary Purpose: Treatment
Official Title: Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • mortality rate [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01899885

Locations
Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Line T Tengberg, MD    +45 38623182 ext +45 50941734    linetofttengberg@gmail.com   
Contact: Nicolai B Foss, MD, DMSc    +45 38625328    nbfoss@gmail.com   
Principal Investigator: Line T Tengberg, MD         
Principal Investigator: Nicolai B Foss, MD, DMSc         
Principal Investigator: Morten Bay-Nielsen, MD, DMSc         
Principal Investigator: Morten L Lauritsen, MD         
Principal Investigator: Lars Lindgaard, MD         
Principal Investigator: Hans J Nielsen, MD, Prof.         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Line T Tengberg, MD Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Line Toft Tengberg, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01899885     History of Changes
Other Study ID Numbers: AHA-37855
Study First Received: July 4, 2013
Last Updated: July 15, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Emergency laparotomy
Emergency laparoscopy

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014