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

Colorectal Cancer Clinical Trial

— KALINOX19  

Official title:

Quality of Colonoscopies Under Kalinox During the COVID 19 Epidemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336617
• Other study ID #: 2022/0018
• Status: Completed
• Start date: May 13, 2022
• Est. completion date: June 13, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who had a colonoscopy under MEOPA between January 2019 and May 2021 at the CHSF.

Exclusion Criteria:

• Colonoscopy under general anesthesia
• Refusal of data collection.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• COVID-19

Intervention

Procedure:
• colonoscopy
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of complete colonoscopies	percentage	at day 0
Secondary	Adenoma detection rate.	percentage	at day 0
Secondary	Polyp detection rate.	percentage	at day 0
Secondary	Colorectal cancer detection rate	percentage	at day 0
Secondary	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)	at day 0