Clinical trial NCT03392584: Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters
Official title: Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Rectal Cancer
Abdominoperineal Resection
Infection
Keywords: Locally advanced rectal cancer
Deep infection
Microdialysis
Surgical site infection
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2018-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced rectal cancer who receive radiotherapy \>25 Gy prior to surgery.

Brief summary: The intention of the study is to explore metabolic and inflammatory parameters in the pelvis after abdominoperineal resection for locally advanced rectal cancer in patients that have received radiation therapy before surgery.

Detailed description: Locally advanced rectal cancers (LARC) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. The Norwegian Radium Hospital Oslo University Hospital is a regional center for treatment of LARC in the south-eastern part of Norway and treat approximately 80-100 patients in this category annually. About 50 of these patients receive abdominoperineal resection (APR) as the main surgical treatment. A very high rate of deep surgical site infections is reported in the APR group internationally, particularly in the patients that have received chemo-radiotherapy. The knowledge of why these patients have such a high rate of infections is scarce.

Microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest.

The investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters, after extensive oncological surgery for LARC in patients that have undergone chemoradiotherapy before surgery. With the knowledge of how the normal biology is, the investigators hypothesize that infection can be readily detected by the biomarkers retrieved by microdialysis.

Eligibility criteria: Inclusion Criteria:

* Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
* operation with APR.
* have accepted and signed the consent form.

Exclusion Criteria:

* APR for other reasons

Primary outcomes:
measure: Monitoring intermediate metabolites in the remnant muscular tissue of the pelvis floor with microdialysis catheters after neoadjuvant CRT and subsequent APR for LARC.
timeFrame: August 2023
Secondary outcomes:
measure: Monitoring inflammatory mediators in the remnant muscular tissue of the pelvis floor with microdialysis catheters after neoadjuvant CRT and subsequent APR for LARC.
timeFrame: August 2023
measure: Monitoring inflammatory mediators in blood after neoadjuvant CRT and subsequent APR for LARC.
timeFrame: August 2023
measure: Measure inflammatory mediators in pelvic drain fluid after neoadjuvant CRT and subsequent APR for LARC.
timeFrame: August 2023
measure: Measure the common innate immune defect MBL deficiency in blood in the study population.
timeFrame: August 2023
measure: Measure intermediate metabolites and inflammatory mediators after neoadjuvant CRT and subsequent APR for LARC with reconstruction of the perineum with VRAM.
timeFrame: August 2023
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Radium Hospital Oslo University Hospital
Study officials:
affiliation: Surgeon, The Department of Gastroenterological Surgery, The Norwegian Radium Hospital, Oslo University Hospital
name: Ebbe B Thorgersen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: