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NCT02124356 Clinical Trial

Functional Performance Following Emergency High-risk Abdominal Surgery

Emergency High-risk Abdominal Surgery Clinical Trial

Official title:
Functional Performance Following Emergency High-risk Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02124356
Other study ID # HH-AHA-FYS-01
Secondary ID H-2-2014-FSP31
Status Completed
Phase N/A
First received April 23, 2014
Last updated October 2, 2014
Start date April 2014
Est. completion date August 2014

Study information
Verified date October 2014
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Research Ethics Committees of the Capital Region of Denmark
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Evaluation of functional performance

Locations
Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other New Mobility Score (NMS) NMS is a measure of pre-hospital functional level. At inclusion/baseline No
Primary Basic mobility evaluated by the Cumulated Ambulation Score (CAS) 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). No
Secondary Physical activity assessment with accelerometer (ActivePAL) Daily on postoperative day 1 to 7. No
Secondary Visual Analog Scale (VAS) 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). No
Secondary Assessment of Motor and Process Skills (AMPS) AMPS measures a person's performance capacity for activities of daily living (ADL) and/or independent living. One time at postoperative day 4. No