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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014