Clinical trial NCT03436004: Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
Official title: Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Adenoma Colon
Keywords: Colonoscopy
Adenoma
Adenoma detection rate
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2018-02-19
Enrollment: 1453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Multicenter prospective trial with medical device
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study

Detailed description: Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.

Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.

Eligibility criteria: Inclusion Criteria:

All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:

1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.
2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program.
3. Patients with a family history of CRC and indication of screening colonoscopy.
4. Patients with follow-up colonoscopy indication by personal history of adenomas.

Exclusion Criteria:

1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).
2. Symptomatic patients with indication of diagnostic colonoscopy.
3. Patients with a personal history of CRC.
4. Patients with a personal history of chronic inflammatory bowel disease (IBD).
5. Patients with a known personal history of hereditary CRC syndrome:

   I. No polyposis (Lynch syndrome). II. Polypic.
6. Patients with suspected attenuated polyposis (\> 20 adenomas) with genetic diagnosis not defined.
7. Patients with total or partial colic resection.
8. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year
9. Pregnant or breastfeeding mothers.
10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.
11. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.

Primary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: 1 day
measure: Mean adenoma per procedure (MAP)
timeFrame: 1 day
Secondary outcomes:
measure: Total number of adenomas detected by colonoscopy
timeFrame: 1 day
measure: Total number of advanced adenomas detected by colonoscopy
timeFrame: 1 day
measure: Total number of serrated lesions with or without detected dysplasia by colonoscopy
timeFrame: 1 day
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
Study officials:
affiliation: Puerta de Hierro University Hospital
name: Alberto Herreros de Tejada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Paz University Hospital
name: Aurora Burgos, MD
role: PRINCIPAL_INVESTIGATOR
References: