Colorectal DisordersCHIRCOLRECNCT04704817
Prospective Database for Colonic or Rectal Resection Surgery Patients
An observational study of Colorectal Disorders, run by Institut Paoli-Calmettes.
Trial summary
Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- obsevation
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Dec 2071
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults treated ot to be treated for colonic and or rectal resection
Who may be able to join
- Patients treated for colonic and / or rectal resection in the oncological digestive surgery department of the Paoli-Calmettes Institute,
- Patients over 18 years old,
- Affiliation to a social security scheme, or beneficiary of such a scheme.
Who cannot join
None listed.
About this study
Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer).
Read the detailed description
Colorectal cancer is the second leading cause of cancer death in France. It accounts for nearly 12% of all cancer deaths, especially among those 65 and over. However, mortality has declined steadily since 1980.
Access to screening for colorectal cancer and resection of precancerous lesions partly explains this decline. All sexes combined, it is estimated that about one in five colorectal cancer is diagnosed at a limited local stage. The treatment is then less heavy and gives better results.
With the development of Enhanced Recovery After Surgery (ERAS) protocols and their extension to rectal excision, it becomes imperative to be able to collect operative data from these patients on a perennial basis for the purpose of evaluating our results. Finally, the evaluations resulting from this database could have prognostic value and ultimately allow us to adapt the surgical management of the patient according to the results.
- Conditions
- Colorectal Disorders
- Being tested
- obsevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obsevationOther
prospective data collection for colonic or rectal surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical events
to asses postoperative effects of colonic or rectal excision by collecting clinical events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2051 (estimated)
- Study completionDec 2071 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704817
- Sponsor's protocol ID
- CHIRCOLREC-IPC 2018-017
- Acronym
- CHIRCOLREC
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 12 Jan 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 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Database for Colonic or Rectal Resection Surgery Patients
- ClinicalTrials.gov ID
- NCT04704817
- Acronym / sponsor ID
- CHIRCOLREC / CHIRCOLREC-IPC 2018-017
- Conditions
- Colorectal Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2051 (estimated)
- Study completion
- Dec 2071 (estimated)
- First posted
- 12 Jan 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.
Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer).
Detailed description
Colorectal cancer is the second leading cause of cancer death in France. It accounts for nearly 12% of all cancer deaths, especially among those 65 and over. However, mortality has declined steadily since 1980.
Access to screening for colorectal cancer and resection of precancerous lesions partly explains this decline. All sexes combined, it is estimated that about one in five colorectal cancer is diagnosed at a limited local stage. The treatment is then less heavy and gives better results.
With the development of Enhanced Recovery After Surgery (ERAS) protocols and their extension to rectal excision, it becomes imperative to be able to collect operative data from these patients on a perennial basis for the purpose of evaluating our results. Finally, the evaluations resulting from this database could have prognostic value and ultimately allow us to adapt the surgical management of the patient according to the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults treated ot to be treated for colonic and or rectal resection
Key inclusion criteria (3 listed)
- Patients treated for colonic and / or rectal resection in the oncological digestive surgery department of the Paoli-Calmettes Institute,
- Patients over 18 years old,
- Affiliation to a social security scheme, or beneficiary of such a scheme.
Key exclusion criteria (0 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 |
|---|---|---|
| obsevationprospective data collection for colonic or rectal surgery | Other | – |
Primary outcome
clinical events
Time frame: 5 years
to asses postoperative effects of colonic or rectal excision by collecting clinical events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
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 Colorectal Disorders, run by Institut Paoli-Calmettes.
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 3 inclusion and 0 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: opening soon, as of the sponsor's last update on 12 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
clinical events (time frame: 5 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 12 Jan 2021; AzTrials last refreshed its copy on 29 Oct 2026.