Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002061213
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Date results provided
21/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Physical activity and ambulation on Post-Operative Complications in Abdominal Surgeries.
Scientific title
Observational assessment of correlation between early ambulation and postoperative complications in abdominal surgeries
Secondary ID [1] 296839 0
0736-13-SMC
Universal Trial Number (UTN)
U1111-1225-3278
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative complications 310748 0
Postoperative ileus 310749 0
Condition category
Condition code
Surgery 309440 309440 0 0
Other surgery
Oral and Gastrointestinal 309541 309541 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
(Observational) Patients undergoing abdominal surgeries we be followed during their hospitalization and assessed for daily ambulation, passage of gas and/or bowel movements, nausea and/or vomiting and for development of post-operative complications. Additionally, hospital readmission and later complication occurring up to 30 days post-op will be assessed.
Daily ambulation will be measured continuously throughout the hospitalization using non-invasive, digital ankle pedometers. Patients will be fitted with water-resistant pedometers on the day of surgery and the devices will be kept on until discharge.
Intervention code [1] 313124 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308395 0
Post-operative complications will be graded using the Clavien-Dindo (CD) scale. In case of multiple complications per patient, the highest graded class will be recorded. In case of hospital readmission (within 30 days of initial discharge) due to a late complication, that too will be used for the assessment.
Timepoint [1] 308395 0
Post-operative complications will monitored daily throughout the hospital stay, Upon discharge the complication CD grade will be recorded.
Secondary outcome [1] 354852 0
Time of 1st passage of gas post-op, based on patient reporting during daily clinical assessment.
Timepoint [1] 354852 0
Assessed daily until hospital discharge
Secondary outcome [2] 354853 0
Time of 1st bowel movement post-op, based on patient reporting during daily clinical assessment and on nursing staff reports.
Timepoint [2] 354853 0
Assessed daily until hospital discharge
Secondary outcome [3] 354854 0
Occurrence of hospital readmission (to the investigating institution), after initial discharge - Automated computerized notices will be used to alert clinical staff to participation in study and to inform investigative team. Additionally, after a month from initial discharge, the computerized medical records will be assessed for 30 day readmission events.
Timepoint [3] 354854 0
up to 30 days post surgery
Secondary outcome [4] 365217 0
Ambulation, as assessed by daily measurement of patient steps (using a digital pedometer)
Timepoint [4] 365217 0
Assessed daily until hospital discharge

Eligibility
Key inclusion criteria
Patients admitted for elective surgery, able to ambulate normally according to mobility score criteria CAS Score >3 NMS Score > 5, GPPAQ Score of "Moderately Inactive"/"Moderately Active"/"Active".
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Spinal/Pelvic or limb injury preventing ambulation, delirium/dementia or other cognitive or neurological impairment preventing informed consent and cooperation, continued regional anaesthesia preventing adequate ambulation, high risk for abdominal wound dehiscence preventing adequate ambulation, previous history of wound dehiscence, large ventral hernia, morbidly obese (BMI>40), serum albumin < 3.0 mg/dl, uncontrolled or chronic pain preventing normal ambulation, age below 18 years or above 85 years and history of any illicit drug use or alcoholism within the past year.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study's aim is to assess correlation between ambulation (measured in steps) and post-operative complications (graded according to the Clavien-Dindo scale). Assuming a correlation coefficient of -0.2 - -0.15 (p<0.05) the required sample size is 58-33. In order to account for heterogeneity of different surgical procedures, the study will recruit a total of 100 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/09/2014
Date of last participant enrolment
Anticipated
Actual
31/03/2016
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 21116 0
Israel
State/province [1] 21116 0

Funding & Sponsors
Funding source category [1] 301415 0
Self funded/Unfunded
Name [1] 301415 0
Unfunded
Country [1] 301415 0
Primary sponsor type
Individual
Name
Oded Zmora, MD
Address
Department of Surgery
Chaim Sheba Medical Center,
Tel-Hashomer, Israel, 52621
Country
Israel
Secondary sponsor category [1] 301091 0
Individual
Name [1] 301091 0
Avinoam Nevler, MD
Address [1] 301091 0
Department of Surgery
Chaim Sheba Medical Center,
Tel-Hashomer, Israel, 52621
Country [1] 301091 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302148 0
Sheba Medical Center IRB
Ethics committee address [1] 302148 0
Ethics committee country [1] 302148 0
Israel
Date submitted for ethics approval [1] 302148 0
26/11/2013
Approval date [1] 302148 0
26/01/2014
Ethics approval number [1] 302148 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89286 0
Dr Avinoam Nevler
Address 89286 0
Department of Surgery
Chaim Sheba Medical Center
Tel-Hashomer, 52621
Country 89286 0
Israel
Phone 89286 0
+972-3-5302235
Fax 89286 0
Email 89286 0
[email protected]
Contact person for public queries
Name 89287 0
Yoni Nevo
Address 89287 0
Department of Surgery
Chaim Sheba Medical Center
Tel-Hashomer, 52621
Country 89287 0
Israel
Phone 89287 0
+972-3-5302414
Fax 89287 0
Email 89287 0
[email protected]
Contact person for scientific queries
Name 89288 0
Yoni Nevo
Address 89288 0
Department of Surgery
Chaim Sheba Medical Center
Tel-Hashomer, 52621
Country 89288 0
Israel
Phone 89288 0
+972-3-5302414
Fax 89288 0
Email 89288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.