A Real-world Study to Examine the Relationship Between Simple Physical Functioning Tests, Complications and Recovery Following Abdominal Surgery.

NCT03930784 | Completed

• 1 other identifier: 043/16
• Study Type: observational
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery--Complications; Abdomen; Physical Activity

Keywords

physical function; recovery; abdominal

Outcome Measures

Primary Outcomes (1)

• Number of participants with complications & changes over time points.

  Defined as occuring within the first 30 days post-operatively using the Clavien Dindo classification

  (1) 0-29 days, (2) 30 and (3) 60 days post operatively

Secondary Outcomes (7)

• Spirometry to measure lung function

  2-4 weeks pre-operatively

• Peak Cough Flow to measure cough strength

  2-4 weeks pre-operatively

• Six Minute Walk Test to measure exercise capacity

  2-4 weeks pre-operatively

• Thirty Second Sit to Stand Test to measure endurance

  2-4 weeks pre-operatively

• Grip strength.

  2-4 weeks pre-operatively

Study Arms (1)

Participants

Divided for analysis as having suffered post-operative complications or not

Other: Nil intervention

Interventions

Nil intervention OTHER

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants scheduled to under-go elective abdominal surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Limerick: lead
• University of Dublin, Trinity College: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist, Practice Tutor

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: September 21, 2016
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share