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

June 11, 2015 updated by: Line Toft Tengberg, Hvidovre University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mortality rate
Time Frame: Within 30 days of surgery
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Line T Tengberg, MD, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHA-37855

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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