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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04324567
Other study ID # 2019/810
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 9, 2019
Est. completion date March 5, 2022

Study information

Verified date March 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.


Description:

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Study Design


Locations

Country Name City State
Norway The Norwegian Radium Hospital Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Monitoring inflammatory mediators in blood after neoadjuvant CRT and subsequent APR for LARC. Blood be analysed using a multiplex cytokine assay (Bio-Plex Human Cytokine 27-Plex Panel, Bio-Rad Laboratories Inc., Hercules, CA). The following cytokines, chemokines and growth factors will be measured (all in pg/mL): Activated complement component 5 (C5a) Interleukin (IL) 1 beta (IL-1ß), IL-1 receptor antagonist (IL-1Ra), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17, Eotaxin (CCL11), basic fibroblast growth factor (bFGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFNG), interferon gamma inducible protein-10 (IP-10 or CXCL10), monocyte chemoattractant protein-1 (MCP-1 or CCL2), macrophage inflammatory protein-1-alpha (MIP-1a or CCL3), macrophage inflammatory protein-1-beta (MIP-1ß or CCL4), platelet-derived growth factor-BB (PDGF-BB), regulated upon activation, normal T cell expressed and secreted (RANTES or CCL5), TNF-a and VEGF. December 2023
Other Monitoring inflammatory mediators in pelvic drain fluid after neoadjuvant CRT and subsequent APR for LARC. Blood be analysed using a multiplex cytokine assay (Bio-Plex Human Cytokine 27-Plex Panel, Bio-Rad Laboratories Inc., Hercules, CA). The following cytokines, chemokines and growth factors will be measured (all in pg/mL): Activated complement component 5 (C5a) Interleukin (IL) 1 beta (IL-1ß), IL-1 receptor antagonist (IL-1Ra), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17, Eotaxin (CCL11), basic fibroblast growth factor (bFGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFNG), interferon gamma inducible protein-10 (IP-10 or CXCL10), monocyte chemoattractant protein-1 (MCP-1 or CCL2), macrophage inflammatory protein-1-alpha (MIP-1a or CCL3), macrophage inflammatory protein-1-beta (MIP-1ß or CCL4), platelet-derived growth factor-BB (PDGF-BB), regulated upon activation, normal T cell expressed and secreted (RANTES or CCL5), TNF-a and VEGF. December 2023
Other Monitoring intermediate metabolites in the remnant muscular tissue of the pelvis floor in up to 10 patients 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. December 2023
Primary Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery CRP will be measured prior to surgery as well as on a daily basis the first 4 postoperative days. Peak values of CRP will be compared between patients undergoing open versus robot-assisted surgery. December 2022
Secondary Overall survival at 1 year follow up after surgery Differences between patients undergoing open versus robot-assisted surgery will be registered. December 2024
Secondary Progression-free survival at 1 year follow up after surgery Differences between patients undergoing open versus robot-assisted surgery will be registered December 2024
Secondary Operating time in minutes Differences between patients undergoing open versus robot-assisted surgery will be registered December 2023
Secondary Hospital length of stay in days after primary surgery Differences between patients undergoing open versus robot-assisted surgery will be registered December 2023
Secondary Postoperative deep pelvic surgical site infection within 30 days after primary surgery Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no) supported by CT-scan December 2023
Secondary Superficial wound infection within 30 days after primary surgery Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no) December 2023
Secondary Dehiscence of the perineal wound at 3 months follow-up Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no) December 2023
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