Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001336178
Ethics application status
Approved
Date submitted
19/08/2019
Date registered
30/09/2019
Date last updated
21/12/2021
Date data sharing statement initially provided
30/09/2019
Date results information initially provided
21/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using C-reactive protein (CRP) for earlier detection of Infectious complications following Colorectal Surgery
Scientific title
Using C-reactive protein (CRP) for earlier detection of Infectious complications following Colorectal Surgery
Secondary ID [1] 299056 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 314080 0
Diverticular disease 314081 0
Inflammatory Bowel Disease 314082 0
Condition category
Condition code
Surgery 312459 312459 0 0
Other surgery
Cancer 312711 312711 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 312712 312712 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective, non-randomised, non-blinded clinical trial comparing two patient groups over two consecutive time periods.

Group 1 (Standard Care) – Patients have CRP levels measured on postoperative days 3 to 5 via a simple peripheral venous blood test which will be collected by a phlebotomist or doctor from the surgical team. A septic screen is performed based on the patients clinical status (vital signs, examination findings) rather than CRP alone.

Group 2 (CRP protocol group) - Patients have CRP levels measured on postoperative days 3 to 5 as for Group 1. If the CRP value is above certain thresholds on these days (>170mg/L on day 3, >125mg/L on day 4, or >50mg/L increase between day 3 and 4, or between day 4 and 5), a 'septic screen' will be performed on the same day to look for a source of infection regardless of normal vital signs or examination findings. This will include:
- CT scan of the abdomen and pelvis
- Chest x-ray
- Cultures of urine, wound and blood/central lines

Fidelity of this data will be ensured through prospective collection of CRP data and complications and further assessed through audit of electronic records and hospital notes at the end of the study.
Intervention code [1] 315327 0
Diagnosis / Prognosis
Comparator / control treatment
The interventional group will be compared to standard care where a septic screen is performed based on clinical status of the patient rather than routine blood tests. This is assessed by doctors on the surgical team and based on the patient's symptoms, vital signs, and physical examination.
Control group
Active

Outcomes
Primary outcome [1] 321105 0
Infectious complications (e.g. wound infection, chest infection, urinary tract infection, anastomotic leak, abdominal collection).
These will be assessed by the surgical team as part of routine clinical care and postoperative follow-up. They will be prospectively recorded by the principal investigator and research team.
Timepoint [1] 321105 0
Assessed daily while in hospital and then weekly once discharged until 30 days post surgery.
Secondary outcome [1] 374003 0
Re-intervention - composite of return to operating theatre or requiring radiological drainage.
These will be assessed by the surgical team as part of routine clinical care and postoperative follow-up. They will be prospectively recorded by the principal investigator and research team.
Timepoint [1] 374003 0
Till 30 days after surgery
Secondary outcome [2] 374004 0
Length of hospital stay assessed using medical records.
Timepoint [2] 374004 0
Till 30 days after surgery
Secondary outcome [3] 374005 0
Readmission assessed using medical records.
Timepoint [3] 374005 0
Till 30 days after surgery

Eligibility
Key inclusion criteria
Adult patients (18 years and older) undergoing elective colonic or rectal resection
with a primary anastomosis (with or without a defunctioning stoma) or reversal of Hartmann’s procedure at Lyell McEwin Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing an emergency operation, no bowel anastomosis, severe renal
impairment (CrCl <30ml/min) or allergy to contrast precluding a contrast-enhanced CT scan

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2019
Actual
1/03/2019
Date of last participant enrolment
Anticipated
Actual
10/08/2020
Date of last data collection
Anticipated
Actual
10/09/2020
Sample size
Target
120
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 303591 0
Hospital
Name [1] 303591 0
Lyell McEwin Hospital
Country [1] 303591 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Hospital
Address
Haydown Road
Elizabeth Vale
SA 5112
Country
Australia
Secondary sponsor category [1] 303676 0
None
Name [1] 303676 0
Address [1] 303676 0
Country [1] 303676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304119 0
Central Adelaide Local Health Network
Ethics committee address [1] 304119 0
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 304119 0
Australia
Date submitted for ethics approval [1] 304119 0
18/08/2019
Approval date [1] 304119 0
13/11/2019
Ethics approval number [1] 304119 0

Summary
Brief summary
The purpose of this study is to evaluate a diagnostic blood test (C-reactive protein) to detect infection and inflammation in the first 3-5 days following bowel surgery.

Who is it for?

You may eligible for this study if you are 18 years or older and undergoing elective colonic or rectal resection with a primary anastomosis at Lyell McEwin Hospital.

Study details

Patients enrolled in the study will be allocated into two groups, the control and intervention group. Participants in the control group will be monitored via standard care protocols at the hospital. The intervention group will have a blood test with a small needle in the arm on days 3, 4 and 5 after surgery. If the CRP value is above certain thresholds on these days, a 'septic screen' will be performed to look for a source of infection. The assessments that you may be involved in include, a CT scan, chest x ray, wound swab and urine/blood tests.

It is hoped this research will help determine if using a clinical protocol based on the CRP to perform an infection screen will allow earlier detection of infectious complications following major colorectal surgery. It is hoped this will also allow for earlier intervention and treatment.
Trial website
Trial related presentations / publications
Public notes
Ethics approval obtained for the prospective interventional group prior to recruitment into this group. This approval included retrospective review of prospectively collected data for patients in the observational group that had their operation prior to the ethical approval date.

Contacts
Principal investigator
Name 95878 0
Dr Primal Singh
Address 95878 0
Department of Surgery
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 95878 0
Australia
Phone 95878 0
+61 8 8133 2344
Fax 95878 0
Email 95878 0
[email protected]
Contact person for public queries
Name 95879 0
Dr Primal Singh
Address 95879 0
Department of Surgery
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 95879 0
Australia
Phone 95879 0
+61 8 8133 2344
Fax 95879 0
Email 95879 0
[email protected]
Contact person for scientific queries
Name 95880 0
Dr Primal Singh
Address 95880 0
Department of Surgery
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 95880 0
Australia
Phone 95880 0
+61 8 8133 2344
Fax 95880 0
Email 95880 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.