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

T

The Institute of Molecular and Translational Medicine, Czech Republic

Status and phase

Completed
Phase 4

Conditions

Circulating Tumor Cell
Colorectal Cancer

Treatments

Drug: Piritramid
Drug: Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT03700541
POACC-2

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

71 participants in 2 patient groups

Morphine
Active Comparator group
Description:
Morphine-based perioperative analgesia
Treatment:
Drug: Morphine
Piritramid
Active Comparator group
Description:
Piritramid-based perioperative analgesia
Treatment:
Drug: Piritramid

Trial contacts and locations

3

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Central trial contact

Emil Berta, MD PhD; Josef Srovnal, MD PhD

Data sourced from clinicaltrials.gov

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