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NCT Number: NCT04324567

Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer

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.

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Key information

Conditions

Locally Advanced Rectal Cancer Abdominoperineal Resection

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Norwegian Radium Hospital Oslo University Hospital

Oslo, 0379, Norway

About this study

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.

Laparoscopic surgery in LARC has been limited because of difficult dissection with straight instruments outside the normal anatomical planes in the confined space of the pelvis. However, recent papers report on better feasibility and good results in robot-assisted surgery for LARC. In respect to shorter postoperative length of stay for minimally invasive compared to open surgery, reduced inflammation may be the explanation, however, results are not conclusive. Most studies comparing open to minimally invasive surgery in colorectal cancer have had conventional laparoscopy as the minimally invasive group, including studies comparing inflammation after surgery. A study on inflammation after laparoscopic robot-assisted major surgery for bladder cancer has recently been published, but to our knowledge no comprehensive studies have been done with patients with rectal cancer resections. Additionally, there are claims that excessive and/or dysregulated inflammatory response after cancer surgery, worsen oncologic outcome. The need to characterize the inflammatory response after laparoscopic robot-assisted surgery of rectal cancer is thus highly relevant and needed.

The investigators want to analyse inflammatory parameters in plasma and peritoneal fluid in patients undergoing robot-assisted and open surgery for LARC.

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 in some patients after extensive robot-assisted oncological surgery for LARC.

The investigators hypothesize inflammatory response differ between patients undergoing open versus robot-assisted surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • APR for other reasons

Treatment and study plan

Primary outcomes

  1. Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery

    Time frame: December 2022

    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.

Secondary outcomes

  1. Overall survival at 1 year follow up after surgery

    Time frame: December 2024

    Differences between patients undergoing open versus robot-assisted surgery will be registered.

  2. Progression-free survival at 1 year follow up after surgery

    Time frame: December 2024

    Differences between patients undergoing open versus robot-assisted surgery will be registered

  3. Operating time in minutes

    Time frame: December 2023

    Differences between patients undergoing open versus robot-assisted surgery will be registered

  4. Hospital length of stay in days after primary surgery

    Time frame: December 2023

    Differences between patients undergoing open versus robot-assisted surgery will be registered

  5. Postoperative deep pelvic surgical site infection within 30 days after primary surgery

    Time frame: December 2023

    Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no) supported by CT-scan

  6. Superficial wound infection within 30 days after primary surgery

    Time frame: December 2023

    Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no)

  7. Dehiscence of the perineal wound at 3 months follow-up

    Time frame: December 2023

    Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no)

Other outcomes

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

    Time frame: December 2023

    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-1β), 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-1α or CCL3), macrophage inflammatory protein-1-beta (MIP-1β or CCL4), platelet-derived growth factor-BB (PDGF-BB), regulated upon activation, normal T cell expressed and secreted (RANTES or CCL5), TNF-α and VEGF.

  2. Monitoring inflammatory mediators in pelvic drain fluid after neoadjuvant CRT and subsequent APR for LARC.

    Time frame: December 2023

    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-1β), 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-1α or CCL3), macrophage inflammatory protein-1-beta (MIP-1β or CCL4), platelet-derived growth factor-BB (PDGF-BB), regulated upon activation, normal T cell expressed and secreted (RANTES or CCL5), TNF-α and VEGF.

  3. 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.

    Time frame: December 2023

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Acronym: APR-IMM

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2020
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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