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NCT01899885 Clinical Trial

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

Intestinal Obstruction Clinical Trial

— AHA  

Official title:
Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01899885
Other study ID # AHA-37855
Secondary ID
Status Completed
Phase N/A
First received July 4, 2013
Last updated June 11, 2015
Start date June 2013
Est. completion date June 2015

Study information
Verified date June 2015
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• AHA (Acute Highrisk Abdominalsurgery): Optimized Course
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

Locations
Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality rate Within 30 days of surgery Yes
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