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Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery (POACC-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03700541
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : December 29, 2021
Sponsor:
Collaborators:
General University Hospital, Prague
Tomas Bata Hospital, Czech Republic
University Hospital Ostrava
Hospital Novy Jicin
Information provided by (Responsible Party):
The Institute of Molecular and Translational Medicine, Czech Republic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Circulating Tumor Cell Drug: Morphine Drug: Piritramid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Morphine
Morphine-based perioperative analgesia
 Drug: Morphine
Morphine intravenous
Active Comparator: Piritramid
Piritramid-based perioperative analgesia
 Drug: Piritramid
Piritramid intravenous


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Pain assessment [ Time Frame: Time Frame: 3 days postoperatively ]
    Pain intensity assessed using Numerical Rating Scale (0-10)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700541


Contacts
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Contact: Emil Berta, MD PhD 00420608801303 e.berta@email.cz
Contact: Josef Srovnal, MD PhD 00420585632111 srovnalj@upol.cz

Locations
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Czechia
T. Bata Regional Hospital Zlin Recruiting
Zlin, Jihomoravsky Kraj, Czechia, 76275
Contact: Tomas Gabrhelik, MD, PhD    +420577552280    Tomas.Gabrhelik@bnzlin.cz   
University Hospital Ostrava Recruiting
Ostrava, Czechia, 708 52
Contact: Jan Máca, MD PhD    ‭+420603728998‬      
General University Hospital Recruiting
Prague, Czechia, 12808
Contact: Pavel Michalek, MD PhD    ‭+420602776261‬      
Sponsors and Collaborators
The Institute of Molecular and Translational Medicine, Czech Republic
General University Hospital, Prague
Tomas Bata Hospital, Czech Republic
University Hospital Ostrava
Hospital Novy Jicin
Investigators
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Principal Investigator: Marian Hajduch, MD PhD Institute of Molecular and Translational Medicine, Palacky University, Olomouc
More Information
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Responsible Party: The Institute of Molecular and Translational Medicine, Czech Republic
ClinicalTrials.gov Identifier: NCT03700541    
Other Study ID Numbers: POACC-2
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Institute of Molecular and Translational Medicine, Czech Republic:
Perioperative analgesia
Colorectal Cancer
Circulating Tumor Cell
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplastic Cells, Circulating
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Morphine
Pirinitramide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents