Colorectal (Colon or Rectal) Cancer
Conditions
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.
Interventions
PROCEDUREColonoscopy under hypnosis
The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete colonoscopies | The day of the colonoscopy, from the start to the end of the colonoscopy | Rate of complete colonoscopies: a colonoscopy is said to be complete when the endoscopist visualizes the caecal fundus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of pain | During the consultation before the colonoscopy | 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. |
| Duration of colonoscopy | The day of colonoscopy from the start to the end of the exam | 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. |
| Rate of polyps resected | The day of colonoscopy from the start to the end of the exam | compare the rate of resected polyps between the two groups |
| Level of anxiety | The day of the colonoscopy, before the exam | Level of anxiety is measured by the State-Trait Anxiety Inventory (Form Y) scale |
| Patient satisfaction | Up to 24 hours the day of the colonoscopy | 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. |
| Medico economic criteria | To the day of the exam to 3 months after | 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%). |
| Rate of complications | To the day of the exam to 8 days after | 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 |
Countries
France
Contacts
Primary ContactDriffa MOUSSATA, PhD
Backup ContactElodie MOUSSET
Outcome results
None listed