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

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Surgery--Complications; Abdomen
• Intervention / Treatment: Other: Nil intervention

• Study Type: Observational
• Enrollment (Actual): 49

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants scheduled to under-go elective abdominal surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; Divided for analysis as having suffered post-operative complications or not	Other: Nil intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry to measure lung function	Spirometry was performed to obtain the participant's vital capacity, forced vital capacity, forced expiratory pressure in one second ratio and peak expiratory flow rate. The instructions and methods used were as per the American Thoracic Society Guidelines 2005. Testing required participants to perform two different tests, three times each. In the initial test, participants were seated and instructed to inhale as deeply as possible before blowing into the spirometer until they felt they needed to inhale again. The second test required them to be seated and after a maximal inhalation, to exhale as forcefully as they could until they felt the need to inhale again. Results were recorded numerically and as a percentage compared to norms of the same sex, race, age, and height. This data was generated by the spirometer (Vitalograph Model 2120 Hand Held REF 79XXX) post testing.	2-4 weeks pre-operatively
Peak Cough Flow to measure cough strength	This was performed by attaching a naso-oral mask to a peak flow meter (Mini- Wright Peak Flow Meter, Clement Clarke International). Figure 2.5. Participants were requested to inhale maximally, in a seated position, prior to placing the mask over their nose and mouth, and coughing forcefully. This was repeated three times to give numerical scores. The highest score was recorded. New face masks and flow meters were used for each patient. Results were recorded in litres per minute (L/min). The researcher attempted to limit any reliability bias by using standardised instructions and corrections as required.	2-4 weeks pre-operatively
Six Minute Walk Test to measure exercise capacity	This was performed as per the ATS guidelines 2002, as recommended by Biccard 2005. Participants were instructed to walk up and down a thirty-metre distance, over a six-minute period, and each length was recorded. The thirty-metre distance was measured with each metre marked, and the same area used for each test. If they were not at a start or endpoint at the six-minute mark, the distance that they had covered was recorded. Predicted distance was calculated against normative data based on age, sex, weight and height. Participants peak oxygen uptake (VO2Peak) was also calculated as per Ross et al 2010.	2-4 weeks pre-operatively
Thirty Second Sit to Stand Test to measure endurance	Participants were asked to go from a seated to standing position and vice versa, as many times as possible in thirty seconds, without the use of their hands to assist. The same standard height chair (17 inches) was used throughout which was placed against a wall for safety. Participants were instructed by the researcher when to start and stop, using a standard stopwatch. When the clock reached thirty seconds, if they were more than half way to a full stand, this was regarded as a stand.Results were recorded as numerical data.	2-4 weeks pre-operatively
Grip strength.	Grip strength was recorded, using a Baseline hydraulic hand held dynamometer, as a measure of overall physical function, independent of lower limb strength.Participants were asked to squeeze the dynamometer maximally for a period of 3 seconds, the result was recorded and the test repeated twice more. An average of the scores was recorded in pounds (lbs).	2-4 weeks pre-operatively
Change over time in activity levels.	This data was collected by the researcher using the short form International Physical Activity Questionnaire (IPAQ) which is a self-reported measure of activity levels in the previous seven days (IPAQ Research Committee 2005). The IPAQ incorporates questions relating to vigorous and moderate activities, as-well as walking and sitting time. It uses patient subjective reports to quantify the time spent, if any, doing the previously mentioned activities in the previous week. The patients weekly metabolic equivalents (METS) were then calculated using the formula and descriptors provided in the scoring protocol.Sedentary time was calculated in weekly minutes by multiplying their daily minutes answers by seven.	(1) 2-4 weeks pre-operatively, (2) 30 and (3) 60 days post operatively
Changes in perceived recovery over time	Participants were asked to self-assess their own physical recovery using the same questions and classification as used in a study by Onerupp et al 2015.	30 and 60 days post operatively

Collaborators and Investigators

• Sponsor: University Hospital of Limerick
• Collaborators: University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): July 6, 2017
• Study Completion (Actual): July 6, 2017

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: recovery; physical function; abdominal
• Other Study ID Numbers: 043/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No