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Immune Monitoring after Colorectal Surgery


- candidate number29733
- NTR NumberNTR7577
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2018
- Secondary IDsNL59261.078.16  
- Public TitleImmune Monitoring after Colorectal Surgery
- Scientific TitleImmune Monitoring after Colorectal Surgery
- ACRONYMIMACS
- hypothesisOur 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.
- Healt Condition(s) or Problem(s) studiedPost-operative infection, Post-operative complications, Urinary tract infections, Sepsis, Surgery, Pneumonia, Colorectal Anastomotic Leakage, Intra-abdominal abscess
- Inclusion criteriaPatients who undergo Hemicolectomy Left, Hemicolectomy Right, Sigmoid Resection or Partial Mesorectal Excision (PME) / Total Mesorectal Excision (TME) will be eligible for inclusion.

In order to be eligible to participate in this study, a subject must meet all of the following 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2017
- planned closingdate1-mrt-2019
- Target number of participants50
- Interventionsblood collection
- Primary outcomePostoperative infectious complications that occur before and/or at presentation at first outpatient department visit, or within 30 days after surgery.

- Colorectal Anastomotic Leakage (CAL)
We defined CAL as an insufficiency of the anastomosis, demonstrated by either endoscopy, CT-scan and/or (water-soluble) contrast enema or re-operation(39).

- Intra-abdominal abscess
Intra-abdominal abscesses demonstrated by imaging studies or with the need to be verified by either surgical drainage or by ultrasonographically, or CT guided aspiration of pus.

- Sepsis
Sepsis was defined by clinical symptoms, if possible combined with a positive blood culture.

- Urinary Tract Infection (UTI)
UTI was defined by a positive urine culture and/or requirement of antibiotic treatment.

- Pneumonia
Pneumonia was defined by a positive X-ray and/or requirement of antibiotic treatment.

- Surgical Site Infection (SSI)
SSI is defined as the presence of pus, either discharged spontaneously or requiring drainage, at the surgical site.
- Secondary outcomeNot applicable
- Timepointssingel timepoint
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate Pim Edomskis
- CONTACT for SCIENTIFIC QUERIESMD, PhD candidate Pim Edomskis
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Sofradim Production, a Medtronic plc company, having a place of business at 116 avenue du Formans, Trevoux, France 01600
- Publications
- Brief summaryRationale: 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.
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. The expression of CD markers of myelomoncytic populations in peripheral blood will be determined with FACS analysis. A blood samples of 10 mL is required before surgery and 3 mL daily at the first three days after surgery.
Study population: The source population for this pilot study will be patients who undergo colorectal resection for malignancies. Patients who undergo Hemicolectomy Left, Hemicolectomy Right, Sigmoid Resection or Partial Mesorectal Excision (PME) / Total Mesorectal Excision (TME) will be eligible for inclusion.
Intervention (if applicable): Not applicable
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)
- Main changes (audit trail)
- RECORD29-okt-2018 - 9-nov-2018


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