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The colonoscopy is the reference examination for the diagnosis of neoplastic lesions in the colon and rectum. Mass screening assessment studies have shown that colonoscopic detection and removal of adenomas in patients selected through fecal occult blood test reduces colorectal cancer incidence and mortality. However, the literature has reported interval cancer cases or adenomas, probably "missed" by the colonoscopy. In theory, using coloured warm water could improve colon preparation by mobilizing the residual faeces, decreasing the colic spasm and increasing the visualization of the pit pattern. Preliminary American studies, led by Leung et al, have shown a very clear increase in the adenoma detection rate.
The investigators' study involves 1 000 patients, treated in the Rhône-Alpes / Auvergne region. The patients present an indication for colonoscopy following a positive fecal occult blood test or symptoms or personal and family histories of pre-cancerous colonic lesions. They will be randomized into two study groups:one of both groups of study: Group 1: patients undergoing a colonoscopy wtih instillation of tepid water tinged with blue (Indigo Carmin®) Group 2: patients undergoing a standard colonoscopy with insufflation of air. The main objective is to show that the colonoscopy with blue water (Indigo Carmin®) enable detection of more lesions than standard colonoscopy with insufflation of air. The two techniques will be also compared in terms of tolerance, of duration of colonoscopy and type of detected lesions.
In case of improved detection of colorectal lesions, the blue water instillation technique of could dramatically change gastroenterologists' practice by becoming the reference method. The expected clinical benefits are potential revealing of more neoplastic lesions and improvement in abdominal discomfort after colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with blue indigo Carmin® | Experimental | Patients undergoing from a colonoscopy with instillation of tepid water (30°C) tinged with indigo Carmin® (0,08/1000) during the endoscope insertion from the anus to the caecum, and with insufflation of air only during withdrawal from the caecum to the anus. |
|
| Standard colonoscopy | Active Comparator | Standard colonoscopy with insufflation of air |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy with blue Indigo Carmin® | Device |
| ||
| Standard colonoscopy with insufflation of air |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of colonoscopy with at least one adenoma detected (or adenoma detection rate) confirmed by a histological reporting. | Within the first 20 days after colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure 1: The characteristics of the lesions detected by the two types of colonoscopy (diameter, macroscopic appearance, histological nature) | We chose three classifications recognized by the medical field:
|
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Inclusion Criteria:
Male or female patients 18 years of age or older
Scores 1 to 3 in ASA (American Society of Anesthesiologists) classification
Patient having an indication for of colonoscopy to detect colorectal neoplastic lesions, which meet at least one of the following conditions:
No coagulation anomalies or no taking of medicine affecting coagulation
Signing of informed consent form before the performance of any procedure related to the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathieu PIOCHE, MD | Contact | 04.72.11.01.45 | +33 | mathieu.pioche@chu-lyon.fr |
| Laurent MAGAUD, CRA | Contact | 04 72 11 51 64 | +33 | laurent.magaud@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thierry PONCHON, MD | Hôpital E. Herriot -Service d'hépato-gastroentérologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot | Recruiting | Lyon | 69437 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28399611 | Derived | Lesne A, Rouquette O, Touzet S, Petit-Laurent F, Tourlonias G, Pasquion A, Rivory J, Aguero Garcete G, Scanzi J, Chalumeau S, Chambon-Augoyard C, Moussata D, Leger-Nguyen F, Degeorges S, Chauvenet M, Fontanges T, Baubet S, Brulet P, Billioud C, Thimonier E, Stroeymeyt-Martin K, Hamel B, Graillot E, Cruiziat C, Scalone O, O'Brien M, Pere-Verge D, Souquet JC, Phelip JM, Poincloux L, Poupon-Bourdy S, Denis A, Magaud L, Ponchon T, Pioche M. Adenoma detection with blue-water infusion colonoscopy: a randomized trial. Endoscopy. 2017 Aug;49(8):765-775. doi: 10.1055/s-0043-105073. Epub 2017 Apr 11. |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Device |
|
| within the first 20 days after colonoscopy. |
| Measure 2 Comparison of the time of the endoscope during the colonoscopy between the two methods | This data is available during the colonoscopy |
| Measure 3 The comparison of the tolerance of the two colonoscopy procedures by assessing patient reported side effects. | Tolerance is measured using a Visual Analog Scale. The questionnaire includes four questions :
In addition to this Visual Analog Scale, we administer a short multiple choice questionnaire:
| At patient's awakening the day of colonoscopy or one day after |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |