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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03700541
Acronym
POACC-2
Enrollment
71
Registered
2018-10-09
Start date
2019-01-07
Completion date
2023-12-06
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cell, Colorectal Cancer

Keywords

Perioperative analgesia, Colorectal Cancer, Circulating Tumor Cell

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.

Interventions

DRUGMorphine

Morphine intravenous

DRUGPiritramid

Piritramid intravenous

Sponsors

General University Hospital, Prague
CollaboratorOTHER
Tomas Bata Hospital, Czech Republic
CollaboratorOTHER
University Hospital Ostrava
CollaboratorOTHER
Hospital Novy Jicin
CollaboratorUNKNOWN
The Institute of Molecular and Translational Medicine, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery1 - 3 days before surgery to 4 weeks after surgeryBaseline 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

MeasureTime frameDescription
Pain assessmentTime Frame: 3 days postoperativelyPain intensity assessed using Numerical Rating Scale (0-10)

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026