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

NCT ID: NCT01899885

Last Updated: 2015-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Perforated Viscus Intestinal Obstruction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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historic control group

Standard treatment in the historic control group

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

AHA (Acute Highrisk Abdominalsurgery): Optimized Course

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Line Toft Tengberg

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Line T Tengberg, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28112798 (View on PubMed)

Other Identifiers

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AHA-37855

Identifier Type: -

Identifier Source: org_study_id

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