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

H

Hvidovre University Hospital

Status

Completed

Conditions

Perforated Viscus
Intestinal Obstruction

Treatments

Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized Course

Study type

Interventional

Funder types

Other

Identifiers

NCT01899885
AHA-37855

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,200 participants in 2 patient groups

historic control group
No Intervention group
Description:
Standard treatment in the historic control group
Intervention group
Active Comparator group
Description:
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
Treatment:
Procedure: AHA (Acute Highrisk Abdominalsurgery): Optimized Course

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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