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

Primary Purpose

Perforated Viscus, Intestinal Obstruction

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
AHA (Acute Highrisk Abdominalsurgery): Optimized Course
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforated Viscus focused on measuring Emergency laparotomy, Emergency laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

historic control group

Intervention group

Arm Description

Standard treatment in the historic control group

AHA (Acute Highrisk Abdominalsurgery): Optimized Course: Intervention before, during and after abdominal surgery. Focus on fast track with multimodal standardized intervention: standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit) GDT-LiDCO fluid management pre-, per- and postoperative Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively

Outcomes

Primary Outcome Measures

mortality rate

Secondary Outcome Measures

Full Information

First Posted
July 4, 2013
Last Updated
June 11, 2015
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01899885
Brief Title
Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
Acronym
AHA
Official Title
Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Viscus, Intestinal Obstruction
Keywords
Emergency laparotomy, Emergency laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
historic control group
Arm Type
No Intervention
Arm Description
Standard treatment in the historic control group
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
AHA (Acute Highrisk Abdominalsurgery): Optimized Course: Intervention before, during and after abdominal surgery. Focus on fast track with multimodal standardized intervention: standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit) GDT-LiDCO fluid management pre-, per- and postoperative Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively
Intervention Type
Procedure
Intervention Name(s)
AHA (Acute Highrisk Abdominalsurgery): Optimized Course
Intervention Description
optimized course: Intervention before, during and after abdominal surgery. Focus on fast track with multimodal standardized intervention: standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit) GDT-LiDCO fluid management pre-, per- and postoperative Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively
Primary Outcome Measure Information:
Title
mortality rate
Time Frame
Within 30 days of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line T Tengberg, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28112798
Citation
Tengberg LT, Bay-Nielsen M, Bisgaard T, Cihoric M, Lauritsen ML, Foss NB; AHA study group. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery. Br J Surg. 2017 Mar;104(4):463-471. doi: 10.1002/bjs.10427. Epub 2017 Jan 23.
Results Reference
derived

Learn more about this trial

Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course

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