Colorectal Cancer Screnning Colonoscopy Under Hypnosis

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

Detailed Description
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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.

Official Title
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Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial

Conditions
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Colorectal (Colon or Rectal) Cancer

Intervention / Treatment
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* Procedure: Colonoscopy under hypnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis<br> | Procedure: Colonoscopy under hypnosis<br>* The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.<br>|
| No Intervention: General anesthesia<br>Common practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete colonoscopies | Rate of complete colonoscopies: a colonoscopy is said to be complete when the endoscopist visualizes the caecal fundus. | The day of the colonoscopy, from the start to the end of the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anxiety | Level of anxiety is measured by the State-Trait Anxiety Inventory (Form Y) scale | The day of the colonoscopy, before the exam | 
| Level of pain | pain level measured by self-evaluation via a visual analog scale between 0 and 10 cm, at the consultation, before and after the colonoscopy in both groups and during the procedure, before returning to the room only in the Hypnosis group. The doctor will present the ungraded side of the VAS to the patient and ask him/her to place the cursor on the maximum pain intensity felt during the procedure. | During the consultation before the colonoscopy | 
| Level of pain | pain level measured by self-evaluation via a visual analog scale between 0 and 10 cm, at the consultation, before and after the colonoscopy in both groups and during the procedure, before returning to the room only in the Hypnosis group. The doctor will present the ungraded side of the VAS to the patient and ask him/her to place the cursor on the maximum pain intensity felt during the procedure. | Up to 24 hours the day of colonoscopy | 
| Duration of colonoscopy | Duration of the endoscopy measured in minutes, distinguishing between: the time between the introduction of the endoscope into the anus and its arrival at the caecal floor and the time required in the opposite direction. The time taken to remove the polyps will be counted. | The day of colonoscopy from the start to the end of the exam | 
| Rate of polyps resected | compare the rate of resected polyps between the two groups | The day of colonoscopy from the start to the end of the exam | 
| Rate of complications | Rate of complications within 8 days post-colonoscopy (perforation, bleeding, inhalation pneumonitis, ...). Patients will be instructed to call back the service in case of complications | To the day of the exam to 8 days after | 
| Patient satisfaction | Patient satisfaction questionnaire regarding the different stages of their care as well as their future wishes regarding the procedure to be considered in the event of a new colonoscopy. The satisfaction questionnaire will focus on the patient's experience of the management on arrival, the set-up in the examination room and the procedure. The best way to verify patient satisfaction is to ask the patient if he or she would like the next colonoscopy to be done under the same conditions. | Up to 24 hours the day of the colonoscopy | 
| Medico economic criteria | Proportion of pairs (Δ cost, Δ effect) belonging to the non-inferiority area in the incremental cost-effectiveness design, for different values of the economic non-inferiority margin and at constant value of the clinical non-inferiority margin (5%). | To the day of the exam to 3 months after |