None listed
Conditions
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.
Interventions
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
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.
Sponsors
Lyell McEwin Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed