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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
Scientific title
Quantifying Surgical Outcomes of Laparoscopic Cholecystectomy and Colectomy using Days Alive and Out of Hospital and Cumulative Sum Analysis.
Secondary ID [1] 291005 0
Nil known
Universal Trial Number (UTN)
U1111-1192-2255
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic cholecystectomy 301825 0
Colectomy 301826 0
Condition category
Condition code
Surgery 301504 301504 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 297006 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300896 0
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.
Timepoint [1] 300896 0
30 days post-operatively, 90 days post-operatively.
Secondary outcome [1] 331145 0
Bile duct injury during laparoscopic cholecystectomy. This outcome will be assessed using data obtained from the Otago Audit System.
Timepoint [1] 331145 0
Intra-operatively.
Secondary outcome [2] 331146 0
Return to theatre after laparoscopic cholecystectomy. This outcome will be assessed using data obtained from the Otago Audit System.
Timepoint [2] 331146 0
30 days post-operatively, 90 days post-operatively
Secondary outcome [3] 331147 0
Conversion to open cholecystectomy from laparoscopic cholecystectomy. This outcome will be assessed using data obtained from the Otago Audit System.
Timepoint [3] 331147 0
Intra-operatively.
Secondary outcome [4] 331148 0
Anastomotic leak after colectomy. This outcome will be assessed using data obtained from the Otago Audit System.
Timepoint [4] 331148 0
30 days post-operatively, 90 days post-operatively.
Secondary outcome [5] 331149 0
Mortality after colectomy. This outcome will be assessed using data obtained from the Health Safety and Quality Commission and the Otago Audit System.
Timepoint [5] 331149 0
30 days post-operatively, 90 days post-operatively.
Secondary outcome [6] 331150 0
Return to theatre after colectomy. This outcome will be assessed using data obtained from the Otago Audit System.
Timepoint [6] 331150 0
30 days post-operatively, 90 days post-operatively.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients whose full data set is not obtainable from hospital records.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2017
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
30/06/2017
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment outside Australia
Country [1] 8611 0
New Zealand
State/province [1] 8611 0
Auckland

Funding & Sponsors
Funding source category [1] 295432 0
University
Name [1] 295432 0
University of Auckland Honours Scholarship
Country [1] 295432 0
New Zealand
Primary sponsor type
Individual
Name
Professor Alan Merry
Address
AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 294286 0
None
Name [1] 294286 0
Address [1] 294286 0
Country [1] 294286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296764 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 296764 0
Ethics committee country [1] 296764 0
New Zealand
Date submitted for ethics approval [1] 296764 0
Approval date [1] 296764 0
15/12/2015
Ethics approval number [1] 296764 0
018364

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1406 1406 0 0
/AnzctrAttachments/372233-UAHPEC Approval.pdf (Ethics approval)
Attachments [2] 1408 1408 0 0
/AnzctrAttachments/372233-Protocol DAOH.doc (Protocol)

Contacts
Principal investigator
Name 71990 0
Prof Alan Merry
Address 71990 0
AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 71990 0
New Zealand
Phone 71990 0
+64 9 923 9301
Fax 71990 0
Email 71990 0
[email protected]
Contact person for public queries
Name 71991 0
Alan Merry
Address 71991 0
AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 71991 0
New Zealand
Phone 71991 0
+64 9 923 9301
Fax 71991 0
Email 71991 0
[email protected]
Contact person for scientific queries
Name 71992 0
Alan Merry
Address 71992 0
AUCKLAND HOSPITAL - Building 599
Level 12, Room 12023
2 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 71992 0
New Zealand
Phone 71992 0
+64 9 923 9301
Fax 71992 0
Email 71992 0
[email protected]

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No Supporting Document Provided



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