Optimization of TreatmentNCT04907435
Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer
An observational study of Optimization of Treatment, run by Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry.
Trial summary
retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Optimization of Treatment
- What is being tested?
- simultaneous operations
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with synchronous metastatic liver lesions with colorectal cancer
Who may be able to join
- patients with synchronous metastatic liver lesions with colorectal cancer
Who cannot join
- -
About this study
retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.
- Conditions
- Optimization of Treatment
- Being tested
- simultaneous operations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous operationsProcedure or surgery
simultaneous operations
| Study group | Role | What they receive |
|---|---|---|
| patient with simultaneous laparoscopic operations | Not described Receives: Procedure: simultaneous operations | |
| patient with simultaneous open operations | Not described Receives: Procedure: simultaneous operations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jan 2011
- Primary completion1 Nov 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimization of TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivanova Olga, Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907435
- Sponsor's protocol ID
- 1
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04907435
- Acronym / sponsor ID
- 1
- Conditions
- Optimization of Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the MinistryUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with simultaneous laparoscopic operations | – | Procedure: simultaneous operations |
| patient with simultaneous open operations | – | Procedure: simultaneous operations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with synchronous metastatic liver lesions with colorectal cancer
Key inclusion criteria (1 listed)
- patients with synchronous metastatic liver lesions with colorectal cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simultaneous operationssimultaneous operations | Procedure or surgery | patient with simultaneous laparoscopic operations, patient with simultaneous open operations |
Primary outcome
Overall survival
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Optimization of Treatment, run by Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.