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Completed

NCT Number: NCT03700541

Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery

To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.

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Key information

Conditions

Colorectal Cancer Circulating Tumor Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

T. Bata Regional Hospital Zlin, Zlin, South Moravian, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing open radical surgery for colorectal cancer
  • age over 18 years
  • signed informed consent

Exclusion criteria

  • intolerance of the study drugs
  • history of CRC surgery
  • neoadjuvant therapy
  • other malignancy not in permanent remission
  • chronic opioid medication or opioid administration within 7 days preoperatively
  • immunosuppressive or corticosteroid therapy
  • surgery within 30 days preoperatively (except minor)
  • chronic or acute infection

Treatment and study plan

Morphine

Drug

Morphine intravenous

Piritramid

Drug

Piritramid intravenous

Primary outcomes

  1. Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery

    Time frame: 1 - 3 days before surgery to 4 weeks after surgery

    Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared.

Secondary outcomes

  1. Pain assessment

    Time frame: Time Frame: 3 days postoperatively

    Pain intensity assessed using Numerical Rating Scale (0-10)

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • General University Hospital, Prague
  • Hospital Novy Jicin
  • Tomas Bata Hospital, Czech Republic
  • University Hospital Ostrava

Registry information

Official study title

Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial

Acronym: POACC-2

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 9, 2018
Registry last updated
Dec 7, 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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