Clinical trial NCT05051046: Colorectal Cancer Screnning Colonoscopy Under Hypnosis
Official title: Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal (Colon or Rectal) Cancer
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Through this study, the effectiveness of hypnosis in the realization of a colonoscopy for the detection of colorectal cancer will be evaluated

Detailed description: Colorectal cancer is the 3rd most common cancer. Colonoscopy, a screening examination, has led to an increase in patient survival. In more than 90% of cases, this examination is performed under general anesthesia (GA) because it is considered painful, even though several studies have shown its feasibility without GA with a good tolerance in 75% of cases. However, only 28% of patients accept the examination without GA because of great apprehension. GA entails an increased risk of complications but also additional costs. Thus, performing colonoscopies without GA would reduce risks and costs by 15 to 30%. In order to make the examination more acceptable and less anxiety-provoking, methods such as hypnosis have been tested with the result that pain and anxiety are reduced and the hemodynamic state of the patients is stabilized, thus reducing the examination time. To date, the majority of studies on hypnosis, of varying indications, are small, mono-centric and non-randomized.

The use of hypnosis for colorectal cancer screening colonoscopies would reduce patient anxiety, avoid complications related to GA and reduce the organizational constraints and costs related to GA.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Undergoing a screening colonoscopy (mass screening Fecal Immunochemical Test positive or as an individual (family history of colon cancer or adenoma, personal history of adenoma, cancer, chronic inflammatory bowel disease) or in the context of a transit disorder, hemorrhage or anemia
* Affiliated with a French social security system
* Having signed a written consent

Exclusion Criteria:

* Patient requiring emergency colonoscopy
* History of colonic resection
* Carriers of behavioral disorders and/or psychiatric illness
* Limited cognitive abilities making it impossible to read or fill out a discrete choice questionnaire (language problems, comprehension problems)
* Contraindication to hypnosis, preventing quality interaction (comprehension and/or language problems, hearing impairment)
* Contraindication to general anesthesia
* Under a legal protection regime
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Rate of complete colonoscopies
timeFrame: The day of the colonoscopy, from the start to the end of the colonoscopy
Secondary outcomes:
measure: Level of anxiety
timeFrame: The day of the colonoscopy, before the exam
measure: Level of pain
timeFrame: During the consultation before the colonoscopy
measure: Level of pain
timeFrame: Up to 24 hours the day of colonoscopy
measure: Duration of colonoscopy
timeFrame: The day of colonoscopy from the start to the end of the exam
measure: Rate of polyps resected
timeFrame: The day of colonoscopy from the start to the end of the exam
measure: Rate of complications
timeFrame: To the day of the exam to 8 days after
measure: Patient satisfaction
timeFrame: Up to 24 hours the day of the colonoscopy
measure: Medico economic criteria
timeFrame: To the day of the exam to 3 months after
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
Study officials:
affiliation: University Hospital Center of Tours
name: Driffa MOUSSATA, PhD
role: PRINCIPAL_INVESTIGATOR
References: