Colorectal Cancer Screnning Colonoscopy Under Hypnosis

Colorectal (Colon or Rectal) Cancer Clinical Trial

— CODEPICCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051046
• Other study ID #: DR200072
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: February 8, 2025

Study information

• Verified date: June 2023
• Source: University Hospital, Tours
• Contact: Driffa MOUSSATA, PhD
• Phone: +33 2 47 47 83 50
• Email: D.MOUSSATA[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 8, 2025
• Est. primary completion date: February 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal (Colon or Rectal) Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Chu Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Medico economic criteria	Proportion of pairs (? cost, ? 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