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 |
|