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Colorectal Cancer Screnning Colonoscopy Under Hypnosis (CODEPICCH)

R

Regional University Hospital Center (CHRU)

Status

Enrolling

Conditions

Colorectal (Colon or Rectal) Cancer

Treatments

Procedure: Colonoscopy under hypnosis

Study type

Interventional

Funder types

Other

Identifiers

NCT05051046
DR200072

Details and patient eligibility

About

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

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 2 patient groups

Hypnosis
Experimental group
Treatment:
Procedure: Colonoscopy under hypnosis
General anesthesia
No Intervention group
Description:
Common practice

Trial contacts and locations

1

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Central trial contact

Driffa MOUSSATA, PhD; Elodie MOUSSET

Data sourced from clinicaltrials.gov

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