Functional Performance Following Emergency High-risk Abdominal Surgery

October 2, 2014 updated by: Morten Tange Kristensen, Hvidovre University Hospital
Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. The hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients (19 years and older) undergoing Emergency High-risk Abdominal Surgery at the Hvidovre University Hospital.

Description

Inclusion Criteria:

  • Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).

Exclusion Criteria:

  • Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency High-risk Abdominal Surgery
Other: Evaluation of functional performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic mobility evaluated by the Cumulated Ambulation Score (CAS)
Time Frame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Factors that limit independency in basic mobility will be evaluated on a daily basis.
Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity assessment with accelerometer (ActivePAL)
Time Frame: Daily on postoperative day 1 to 7.
Daily on postoperative day 1 to 7.
Visual Analog Scale (VAS)
Time Frame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
VAS is a self-reported measure of pain intensity.
Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Assessment of Motor and Process Skills (AMPS)
Time Frame: One time at postoperative day 4.
AMPS measures a person's performance capacity for activities of daily living (ADL) and/or independent living.
One time at postoperative day 4.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Mobility Score (NMS)
Time Frame: At inclusion/baseline
NMS is a measure of pre-hospital functional level.
At inclusion/baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HH-AHA-FYS-01
  • H-2-2014-FSP31 (Registry Identifier: Regional Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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