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

NCT ID: NCT03700541

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2023-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Circulating Tumor Cell

Keywords

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Perioperative analgesia Colorectal Cancer Circulating Tumor Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Morphine

Morphine-based perioperative analgesia

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine intravenous

Piritramid

Piritramid-based perioperative analgesia

Group Type ACTIVE_COMPARATOR

Piritramid

Intervention Type DRUG

Piritramid intravenous

Interventions

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Morphine

Morphine intravenous

Intervention Type DRUG

Piritramid

Piritramid intravenous

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital, Prague

OTHER

Sponsor Role collaborator

Tomas Bata Hospital, Czech Republic

OTHER

Sponsor Role collaborator

University Hospital Ostrava

OTHER

Sponsor Role collaborator

Hospital Novy Jicin

UNKNOWN

Sponsor Role collaborator

The Institute of Molecular and Translational Medicine, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marian Hajduch, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Molecular and Translational Medicine, Palacky University, Olomouc

Locations

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T. Bata Regional Hospital Zlin

Zlin, South Moravian, Czechia

Site Status

University Hospital Ostrava

Ostrava, , Czechia

Site Status

General University Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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POACC-2

Identifier Type: -

Identifier Source: org_study_id