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 (KALINOX19)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: colonoscopy

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 Type: Observational
• Enrollment (Actual): 282

Contacts and Locations

Study Locations

• France
  • Corbeil-essonnes Cedex, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of complete colonoscopies	percentage	at day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate.	percentage	at day 0
Polyp detection rate.	percentage	at day 0
Colorectal cancer detection rate	percentage	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)	at day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: COVID 19; Colorectal cancer; Type of anesthesia; Colonoscopy and polypectomy; Colonoscopy quality indicator
• Additional Relevant MeSH Terms: Digestive System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; COVID-19; Colorectal Neoplasms
• Other Study ID Numbers: 2022/0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No