NCT01899885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

July 4, 2013

Last Update Submit

June 11, 2015

Conditions

Perforated ViscusIntestinal Obstruction

Keywords

Emergency laparotomyEmergency laparoscopy

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    Within 30 days of surgery

Study Arms (2)

historic control group

NO INTERVENTION

Standard treatment in the historic control group

Intervention group

ACTIVE COMPARATOR

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

Interventions

AHA (Acute Highrisk Abdominalsurgery): Optimized CoursePROCEDURE

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing primary emergency laparotomy or laparoscopy
  • patients undergoing reoperation after abdominal surgery.
  • Age \> 18 years

You may not qualify if:

  • Appendectomy
  • Emergency laparoscopic cholecystectomy
  • Emergency diagnostic laparoscopy without intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28112798DERIVED

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

acetohydroxamic acid

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Line T Tengberg, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 16, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

DK(1)