NCT03700541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4 colorectal-cancer

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4 colorectal-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

December 7, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

October 3, 2018

Last Update Submit

December 6, 2023

Conditions

Colorectal CancerCirculating Tumor Cell

Keywords

Perioperative analgesiaColorectal CancerCirculating Tumor Cell

Outcome Measures

Primary Outcomes (1)

  • Change in number of circulating tumor cells prior to surgery to 2 - 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.

    1 - 3 days before surgery to 4 weeks after surgery

Secondary Outcomes (1)

  • Pain assessment

    Time Frame: 3 days postoperatively

Study Arms (2)

Morphine

ACTIVE COMPARATOR

Morphine-based perioperative analgesia

Drug: Morphine

Piritramid

ACTIVE COMPARATOR

Piritramid-based perioperative analgesia

Drug: Piritramid

Interventions

MorphineDRUG

Morphine intravenous

Morphine
PiritramidDRUG

Piritramid intravenous

Piritramid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

T. Bata Regional Hospital Zlin

Zlin, South Moravian, 76275, Czechia

Location

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

General University Hospital

Prague, 12808, Czechia

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplastic Cells, Circulating

Interventions

MorphinePirinitramide

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Marian Hajduch, MD PhD

    Institute of Molecular and Translational Medicine, Palacky University, Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 9, 2018

Study Start

January 7, 2019

Primary Completion

November 1, 2023

Study Completion

December 6, 2023

Last Updated

December 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(3)