Colorectal CancerKALINOX19NCT05336617
It is Possible to Maintain the Performance of Screening Colonoscopies Under MEOPA During the Covid 19 Epidemic Period When Access to the Operating Room is Limited
An observational study of Colorectal Cancer, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
Feedback: during the COVID-19 epidemic, access to operating theaters was restricted so that anesthetists and nurse anesthetists could reinforce the resuscitation workforce. The MEOPA was used as an alternative to sedation, allowing colonoscopies to be carried out, colon polyps and colorectal cancers to be detected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 282 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2022to 13 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults patients who underwent a colonoscopy under Kalinox in the Centre Hospitalier Sud Francilien from 01/01/2019 to 05/31/2021.
Who may be able to join
- Adult patients who had a colonoscopy under MEOPA between January 2019 and May 2021 at the CHSF.
Who cannot join
- Colonoscopy under general anesthesia
- Refusal of data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Colonoscopies Under Kalinox During the COVID 19 Epidemic
Feedback: during the COVID-19 epidemic, access to operating theaters was restricted so that anesthetists and nurse anesthetists could reinforce the resuscitation workforce.
The MEOPA was used as an alternative to sedation, allowing colonoscopies to be carried out, colon polyps and colorectal cancers to be detected.
Read the detailed description
Colonoscopy is a major procedure for screening for cancers and diagnosing colorectal lesions. In France, general anesthesia remains the most widely used sedation method for colonoscopy. Faced with several constraints such as difficulty of access to the operating room, length of hospitalization and contraindications to general anesthesia, several sedation methods have been adopted.
The best known is sedation by MEOPA (equimolar mixture of oxygen protoxide of nitrogen) marketed under the name of Kalinox. It is offered as a second-line treatment after general anesthesia.
Since March 2020, the COVID-19 health crisis has forced us to change our care. Faced with restricted access to the operating room (anesthetists and nurse anesthetists requisitioned to participate in the care of patients in intensive care), colonoscopy under MEOPA was offered to patients who could have benefited from general anesthesia before the crisis. This monocentric retrospective descriptive study at the CHSF (Centre Hospitalier Sud Francilien) will make it possible to assess the quality of colonoscopies performed under MEOPA in the first line.
This is a feedback, the MEOPA having allowed us to continue and maintain the performance of screening colonoscopies during the COVID 19 epidemic.
- Conditions
- Colorectal Cancer
- Being tested
- colonoscopy
- Keywords
- Type of anesthesia, Colonoscopy and polypectomy, Colorectal cancer, Colonoscopy quality indicator, COVID 19
- Medical subject headings
- Colorectal Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Also called MEOPA
A colonoscopy is an exam used to examine the colon and rectum. During a colonoscopy, a long, flexible tube is inserted into the rectum. A tiny video camera at the tip of the tube allows the doctor to view the inside of the entire colon.
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of complete colonoscopies
percentage
Measured: at day 0
Secondary outcomes (4)
Adenoma detection rate.
percentage
Measured: at day 0
Polyp detection rate.
percentage
Measured: at day 0
Colorectal cancer detection rate
percentage
Measured: at day 0
Quality of colonic preparation (Boston score)
Breakdown into 3 groups: good (Boston Bowel Preparation SCALE 7, 8, 9), bad (Boston Bowel Preparation SCALE 4, 5, 6) and unsatisfactory (Boston Bowel Preparation SCALE 1, 2, 3)
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start13 May 2022
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336617
- Sponsor's protocol ID
- 2022/0018
- Acronym
- KALINOX19
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2022
- Last updated
- 15 Sep 2022
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Colonoscopies Under Kalinox During the COVID 19 Epidemic
- ClinicalTrials.gov ID
- NCT05336617
- Acronym / sponsor ID
- KALINOX19 / 2022/0018
- Conditions
- Colorectal Cancer
- Keywords
- Type of anesthesia, Colonoscopy and polypectomy, Colorectal cancer, Colonoscopy quality indicator, COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 20 Apr 2022 (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.
Feedback: during the COVID-19 epidemic, access to operating theaters was restricted so that anesthetists and nurse anesthetists could reinforce the resuscitation workforce.
The MEOPA was used as an alternative to sedation, allowing colonoscopies to be carried out, colon polyps and colorectal cancers to be detected.
Detailed description
Colonoscopy is a major procedure for screening for cancers and diagnosing colorectal lesions. In France, general anesthesia remains the most widely used sedation method for colonoscopy. Faced with several constraints such as difficulty of access to the operating room, length of hospitalization and contraindications to general anesthesia, several sedation methods have been adopted.
The best known is sedation by MEOPA (equimolar mixture of oxygen protoxide of nitrogen) marketed under the name of Kalinox. It is offered as a second-line treatment after general anesthesia.
Since March 2020, the COVID-19 health crisis has forced us to change our care. Faced with restricted access to the operating room (anesthetists and nurse anesthetists requisitioned to participate in the care of patients in intensive care), colonoscopy under MEOPA was offered to patients who could have benefited from general anesthesia before the crisis. This monocentric retrospective descriptive study at the CHSF (Centre Hospitalier Sud Francilien) will make it possible to assess the quality of colonoscopies performed under MEOPA in the first line.
This is a feedback, the MEOPA having allowed us to continue and maintain the performance of screening colonoscopies during the COVID 19 epidemic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients who underwent a colonoscopy under Kalinox in the Centre Hospitalier Sud Francilien from 01/01/2019 to 05/31/2021.
Key inclusion criteria (1 listed)
- Adult patients who had a colonoscopy under MEOPA between January 2019 and May 2021 at the CHSF.
Key exclusion criteria (2 listed)
- Colonoscopy under general anesthesia
- Refusal of data collection.
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 |
|---|---|---|
| colonoscopyAlso: MEOPAA colonoscopy is an exam used to examine the colon and rectum. During a colonoscopy, a long, flexible tube is inserted into the rectum. A tiny video camera at the tip of the tube allows the doctor to view the inside of the entire colon. | Procedure or surgery | – |
Primary outcome
percentage of complete colonoscopies
Time frame: at day 0
percentage
4 secondary outcomes
Adenoma detection rate.
Time frame: at day 0
Polyp detection rate.
Time frame: at day 0
Colorectal cancer detection rate
Time frame: at day 0
Quality of colonic preparation (Boston score)
Time frame: at day 0
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 15 Sep 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Centre Hospitalier Sud Francilien at 1 site in France.
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 2 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 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
percentage of complete colonoscopies (time frame: at day 0). 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 15 Sep 2022.