Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters

NCT03392584 | Completed

• 1 other identifier: 2016/865
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer; Abdominoperineal Resection; Infection

Keywords

Locally advanced rectal cancer; Deep infection; Microdialysis; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• Monitoring intermediate metabolites in the remnant muscular tissue of the pelvis floor with microdialysis catheters after neoadjuvant CRT and subsequent APR for LARC.

  Lactate (mM), pyruvate (µM), lactate/pyruvate ratio, glycerol (µM) and glucose (mM) will be measured in microdialysis fluid from catheters inserted in the remnant muscular tissue of the pelvis floor after neoadjuvant CRT and subsequent APR for LARC to detect deep pelvic surgical site infection. The results will be compared to current standard monitoring. The measures will be done bedside on Iscus analyzer, M Dialysis AB, Stockholm, Sweden. The Iscus analyzer will calculate the lactate/pyruvate ratio.

  August 2023

Secondary Outcomes (5)

• Monitoring inflammatory mediators in the remnant muscular tissue of the pelvis floor with microdialysis catheters after neoadjuvant CRT and subsequent APR for LARC.

  August 2023

• Monitoring inflammatory mediators in blood after neoadjuvant CRT and subsequent APR for LARC.

  August 2023

• Measure inflammatory mediators in pelvic drain fluid after neoadjuvant CRT and subsequent APR for LARC.

  August 2023

• Measure the common innate immune defect MBL deficiency in blood in the study population.

  August 2023

• Measure intermediate metabolites and inflammatory mediators after neoadjuvant CRT and subsequent APR for LARC with reconstruction of the perineum with VRAM.

  August 2023

Study Arms (2)

APR

Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR)

APR with VRAM

Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) and subsequent reconstruction of the perineum with a vertical rectus abdominis myocutaneous flap (VRAM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer who receive radiotherapy \>25 Gy prior to surgery.

You may qualify if:

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

You may not qualify if:

• APR for other reasons

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

The Norwegian Radium Hospital Oslo University Hospital

Oslo, 0379, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microdialysis samples 6-10 times every day. Regularly standard blood samples. Daily samples from pelvic drain. EDTA plasma 3 times a week.

MeSH Terms

Conditions

Infections; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebbe B Thorgersen, MD PhD

  Surgeon, The Department of Gastroenterological Surgery, The Norwegian Radium Hospital, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 8, 2018
• Study Start: October 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: January 8, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

NO (1)