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Trial registered on ANZCTR
Registration number
ACTRN12617000180314
Ethics application status
Approved
Date submitted
30/01/2017
Date registered
2/02/2017
Date last updated
2/02/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Days Alive and Out of Hospital for Laparoscopic Cholecystectomy and Colectomy
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Scientific title
Quantifying Surgical Outcomes of Laparoscopic Cholecystectomy and Colectomy using Days Alive and Out of Hospital and Cumulative Sum Analysis.
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Secondary ID [1]
291005
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Nil known
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Universal Trial Number (UTN)
U1111-1192-2255
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Trial acronym
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Laparoscopic cholecystectomy
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Colectomy
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Condition category
Condition code
Surgery
301504
301504
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a retrospective study of patients undergoing laparoscopic cholecystectomy and colectomy at Auckland City Hospital. Operative data (complications ) for these patients will be obtained from the Otago Audit System (a prospectively maintained registry). "Days Alive and Out of Hospital" (DAOH) values for each patient will be calculated using admissions and mortality data held by the New Zealand Health Safety Quality Commission. The follow-up period over which DAOH values will be calculated will be both 30-days and 90-days.
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Intervention code [1]
297006
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Not applicable
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Days Alive and Out of Hospital is the primary outcome of this study. Days Alive and Out of Hospital will be defined as the number of days spent alive and out of hospital, over a given time period after a patient's operation. Two time periods will be used for this study (30 days and 90 days). Calculating this figure requires the number of “Days Alive in Hospital” and the number of “Days Dead”. Days Alive In hospital (DIH) is defined as the number of days spent in hospital over the post-operative period (30 days or 90 days). This will be obtained by adding the duration of each individual hospital stay over this period (including initial hospital stay and re-admissions). Days Dead (DD) is defined as the number of days from the patient’s death until the end of the post operative period (30 days or 90 days). DAOH will be calculated as either 30 - (DAIH + DD) or 90 - (DAIH + DD) depending on the time frame used. The data inputs needed to calculate DAOH (admissions, length of stay, readmissions and mortality) are held by the Health Quality and Safety Commission. This data will be accessed to assess DAOH for the patients in our study.
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Assessment method [1]
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Timepoint [1]
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30 days post-operatively, 90 days post-operatively.
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Secondary outcome [1]
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Bile duct injury during laparoscopic cholecystectomy. This outcome will be assessed using data obtained from the Otago Audit System.
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Assessment method [1]
331145
0
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Timepoint [1]
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Intra-operatively.
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Secondary outcome [2]
331146
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Return to theatre after laparoscopic cholecystectomy. This outcome will be assessed using data obtained from the Otago Audit System.
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Assessment method [2]
331146
0
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Timepoint [2]
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30 days post-operatively, 90 days post-operatively
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Secondary outcome [3]
331147
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Conversion to open cholecystectomy from laparoscopic cholecystectomy. This outcome will be assessed using data obtained from the Otago Audit System.
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Assessment method [3]
331147
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Timepoint [3]
331147
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Intra-operatively.
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Secondary outcome [4]
331148
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Anastomotic leak after colectomy. This outcome will be assessed using data obtained from the Otago Audit System.
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Assessment method [4]
331148
0
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Timepoint [4]
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30 days post-operatively, 90 days post-operatively.
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Secondary outcome [5]
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Mortality after colectomy. This outcome will be assessed using data obtained from the Health Safety and Quality Commission and the Otago Audit System.
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Assessment method [5]
331149
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Timepoint [5]
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30 days post-operatively, 90 days post-operatively.
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Secondary outcome [6]
331150
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Return to theatre after colectomy. This outcome will be assessed using data obtained from the Otago Audit System.
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Assessment method [6]
331150
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Timepoint [6]
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30 days post-operatively, 90 days post-operatively.
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Eligibility
Key inclusion criteria
1. Males and females, age 18 and over at the time of the procedure.
2. Patients undergoing acute or elective surgery for either Laparoscopic Cholecystectomy or Colectomy, between January 1st 2010-December 31st 2015 (inclusive) under the Department of Surgery at Auckland City Hospital.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients whose full data set is not obtainable from hospital records.
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
We have not conducted any calculations regarding sample size and statistical power, because this is the first time that the outcome measure (DAOH) has been used outside of cardiac patients. The aim of this study is to determine whether DAOH accurately distinguishes between patients experiencing operative complications and patients who do not. We have picked a time range which we think is practically feasible (5 years) to answer this question. If we are unable to tease out differences in DAOH values over 5 years then this measure is a poor discriminator, and our study question (regarding the utility of this metric) is answered. We will conduct interim analyses at yearly intervals so that we can determine the minimum time needed for measurement to take place before you can start discriminating out outcomes.
Rates of the following complications will be recorded:
Laparoscopic cholecystectomy
1. Bile duct injury
2. Return to theatre
3. Conversion to open cholecystectomy
Colectomy
1. Mortality
2. Return to theatre
3. Anastomotic leak
Mean DAOH values will be collected for groups of patients suffering each complication. These DAOH values will be compared against the mean DAOH values of patients with no complications, to determine whether DAOH accurately distinguishes between these patient groups. Measuring complication rates will also allow the construction of Cumulative Sum graphs for each given complication, provided the incidence of outcomes is sufficient. This study design will enable us to definitively answer our study objectives.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/02/2017
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Actual
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Date of last participant enrolment
Anticipated
30/06/2017
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Actual
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Date of last data collection
Anticipated
30/06/2017
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Actual
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Sample size
Target
4000
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Auckland Honours Scholarship
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Address [1]
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University of Auckland, Faculty of Medical and Health Sciences 85 Park Road, Grafton Auckland PO 1023
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Country [1]
295432
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New Zealand
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Primary sponsor type
Individual
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Name
Professor Alan Merry
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Address
AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
294286
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Address [1]
294286
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Country [1]
294286
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296764
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University of Auckland Human Participants Ethics Committee
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Ethics committee address [1]
296764
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Research Office
Level 10, Building 620
49 Symonds Street
Auckland 1010
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Ethics committee country [1]
296764
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New Zealand
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Date submitted for ethics approval [1]
296764
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Approval date [1]
296764
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15/12/2015
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Ethics approval number [1]
296764
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018364
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Summary
Brief summary
The study questions are as follows:
1. Can Days Alive and Out of Hospital (DAOH) be collected from existing data sources for patients undergoing selected general surgical procedures, and does it discriminate between patients who suffer death or other important complications and those who don’t with sufficient sensitivity and specificity to be useful as a tool for monitoring the standard of care at a unit level?
2. Can a set of important technical complications be identified for selected general surgical procedures and their rate of occurrence collected from existing data sources and if so, is the combined rate sufficiently high for useful application in CUSUM analysis of individual surgeon’s technical performance?
The objectives of the project are as follows:
1. To apply DAOH to a retrospective cohort of general surgical patients and explore the utility of this metric in measuring overall quality of care.
2. To measure the rates of surgical complications, and the effect of these complications on DAOH.
3. To measure the rates of surgical complications, and determine whether the incidence of these outcomes is high enough to create CUSUM graphs of surgical performance.
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Trial website
N/A.
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Trial related presentations / publications
N/A.
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Public notes
N/A
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Attachments [1]
1406
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/AnzctrAttachments/372233-UAHPEC Approval.pdf
(Ethics approval)
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Attachments [2]
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/AnzctrAttachments/372233-Protocol DAOH.doc
(Protocol)
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Contacts
Principal investigator
Name
71990
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Prof Alan Merry
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Address
71990
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AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
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Country
71990
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New Zealand
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Phone
71990
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+64 9 923 9301
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Fax
71990
0
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Email
71990
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[email protected]
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Contact person for public queries
Name
71991
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Prof Alan Merry
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Address
71991
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AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
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Country
71991
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New Zealand
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Phone
71991
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+64 9 923 9301
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Fax
71991
0
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Email
71991
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[email protected]
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Contact person for scientific queries
Name
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Prof Alan Merry
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Address
71992
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AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
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Country
71992
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New Zealand
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Phone
71992
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+64 9 923 9301
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Fax
71992
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Email
71992
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[email protected]
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No information has been provided regarding IPD availability
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.
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