Clinical trial NCT03930784: A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.
Official title: A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Abdomen
Physical Activity
Keywords: physical function
recovery
abdominal
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
Collaborators: name: University of Dublin, Trinity College
First posted: 2019-04-29
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants scheduled to under-go elective abdominal surgery

Brief summary: Background: Complications impact physical and psychological recovery and are associated with financial cost. General physical function has not been studied in relation to the development of surgical complications in this cohort.

Objective: Evaluate the physical function performance differences between those who develop complications and those who do not and determine their impact on recovery.

Design: Observational Setting: The pre-operative assessment unit in the University Hospital Limerick. Patients: Forty-nine participants who were planned to undergo abdominal surgery were recruited \& 43 completed the study.

Main outcome measure: Demographics, physical function, lung function, surgical parameters, complications and recovery data was collected.


Eligibility criteria: Inclusion Criteria:

* Written consent to participate in the study
* Eighteen years or above
* Planned for elective abdominal surgery
* American Society of Anaesthesia physical status score \<4.

Exclusion Criteria:

* Abdominal surgery within one year prior to study entry
* Unable or unwilling to give informed consent
* Inability (cognitive) to perform the pre-operative tests, as characterised by inability to understand the information in the patient information leaflet
* Current systemic acute illness
* Scheduled for non-abdominal surgery
* Unstable angina or myocardial infarction in the previous month
* Physical limitation precluding inability to participate in pre-operative tests.

Primary outcomes:
measure: Number of participants with complications & changes over time points.
timeFrame: (1) 0-29 days, (2) 30 and (3) 60 days post operatively
Secondary outcomes:
measure: Spirometry to measure lung function
timeFrame: 2-4 weeks pre-operatively
measure: Peak Cough Flow to measure cough strength
timeFrame: 2-4 weeks pre-operatively
measure: Six Minute Walk Test to measure exercise capacity
timeFrame: 2-4 weeks pre-operatively
measure: Thirty Second Sit to Stand Test to measure endurance
timeFrame: 2-4 weeks pre-operatively
measure: Grip strength.
timeFrame: 2-4 weeks pre-operatively
measure: Change over time in activity levels.
timeFrame: (1) 2-4 weeks pre-operatively, (2) 30 and (3) 60 days post operatively
measure: Changes in perceived recovery over time
timeFrame: 30 and 60 days post operatively
Other outcomes:
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