To assess the predictive value of immune monitoring after colorectal surgery for early detection of postoperative infectious complications.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
Postoperative infectious complications that occur within 30 days after surgery.
- Colorectal Anastomotic Leakage (CAL)
- Intra-abdominal abscess
- Sepsis
- Urinary Tract Infection (UTI)
- Pneumonia
- Surgical Site Infection (SSI)
Secondary outcome
Not applicable
Background summary
Our hypothesis is that infectious stimuli lead to a marker profile of
neutrophils and monocytes that allows the distinction of patients with
increased risk of infectious complications from those without, despite the
general inflammatory state induced by the surgical procedure.
Study objective
To assess the predictive value of immune monitoring after colorectal surgery
for early detection of postoperative infectious complications.
Study design
The IMACS study is a prospective pilot study that assesses the predictive value
of immune monitoring after colorectal surgery for early detection of infectious
complications. Participation requires daily venepuncture of 3 mL from day of
surgery till the third postoperative day.
Study burden and risks
The extent of burden and risks associated with participation could be
considered as small. The invasive procedure performed on behalf of the IMACS
study is venepuncture (3 mL) performed at surgery and daily at the first three
postoperative days. In case of standard clinical practice after colorectal
surgery venepuncture is quite common to monitor the postoperative course.
Whether venepuncture is performed during standard practice depends on the
extent of patient*s recovery. Therefore the collection of blood samples on
behalf of the IMACS study does not always includes extra venepuncture but
sometimes 3 mL extra blood collection if venepuncture is indicated due to
standard clinical practice.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Informed Consent
- Primary anastomosis
- Colorectal carcinoma
Exclusion criteria
- Age < 18 years
- Pregnancy
- Preoperative chemotherapy and/or radiotherapy
- Perioperative HIPEC treatment
- Inflammatory disease (i.e. inflammatory bowel disease, auto-immune
deficiencies)
- Immunosuppressant drug use
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL59261.078.16 |
Other | NTC7577 |
OMON | NL-OMON27730 |