Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Performance Following Emergency High-risk Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124356
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Morten Tange Kristensen, Hvidovre University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Emergency High-risk Abdominal Surgery Other: Evaluation of functional performance

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Performance Following Emergency High-risk Abdominal Surgery
Study Start Date : April 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Physical activity assessment with accelerometer (ActivePAL) [ Time Frame: Daily on postoperative day 1 to 7. ]
  2. 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.

  3. 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.


Other Outcome Measures:
  1. New Mobility Score (NMS) [ Time Frame: At inclusion/baseline ]
    NMS is a measure of pre-hospital functional level.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients (19 years and older) undergoing Emergency High-risk Abdominal Surgery at the Hvidovre University Hospital.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124356


Locations
Layout table for location information
Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Hvidovre University Hospital

Layout table for additonal information
Responsible Party: Morten Tange Kristensen, Seniorresearcher, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02124356     History of Changes
Other Study ID Numbers: HH-AHA-FYS-01
H-2-2014-FSP31 ( Registry Identifier: Regional Ethics Committee )
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes