Colorectal Cancer Screnning Colonoscopy Under Hypnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colonoscopy under hypnosis.
- Who it may be relevant to
- Registry conditions: Colorectal (Colon or Rectal) Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Colorectal Cancer Screnning Colonoscopy Under Hypnosis: A Multicenter Randomized Non-Inferiority Trial
Overview
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
- Procedure Colonoscopy under hypnosis
The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
Primary outcome measures
- Rate of complete colonoscopies [Time frame: The day of the colonoscopy, from the start to the end of the colonoscopy]
Secondary outcome measures (8)
- Level of anxiety [Time frame: The day of the colonoscopy, before the exam]
- Level of pain [Time frame: During the consultation before the colonoscopy]
- Level of pain [Time frame: Up to 24 hours the day of colonoscopy]
- Duration of colonoscopy [Time frame: The day of colonoscopy from the start to the end of the exam]
- Rate of polyps resected [Time frame: The day of colonoscopy from the start to the end of the exam]
- Rate of complications [Time frame: To the day of the exam to 8 days after]
- Patient satisfaction [Time frame: Up to 24 hours the day of the colonoscopy]
- Medico economic criteria [Time frame: To the day of the exam to 3 months after]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Chu Angers — Angers
Identifiers
NCT: NCT05051046 · DR200072