None listed
Conditions
Brief summary
This is a multicentre, open-label, randomized, parallel-group study. The study will enroll consecutive patients who will underwent colonoscopy using a conventional colonoscope at the Reina Sofia Clinic and Colombia Clinic in Bogota, Colombia. During the first part of the procedure the colonoscope is inserted through the rectum and advanced to the large intestine, using conventional colonoscopy in both groups for detecting lesions. When the colonoscope will begin to be retrieved from the cecum, patients will be randomized to conventional colonoscopy or the NBI system colonoscopy. Sealed randomization envelopes are provided and are held centrally at each investigational site. An envelope is opened when a patient agrees to take part and when the endoscopist will begin to retrieve the colonoscope from the cecum.
Interventions
During the first part of the procedure the colonoscope is inserted through the rectum and advanced to the large intestine, using conventional colonoscopy in both groups for detecting lesions. Thereafter, patients will be randomly assigned to colonoscope withdrawal using either conventional wide-angle (approximately 10 minutes) or narrow-band imaging (NBI) technology. The colonoscopies will be performed using High Definition monitors. Appropriate and complete bowel preparation before colonoscopy
During the first part of the procedure the colonoscope is inserted through the rectum and advanced to the large intestine, using conventional colonoscopy in both groups for detecting lesions. Thereafter, patients will be randomly assigned to colonoscope withdrawal using either conventional wide-angle (approximately 10 minutes) or narrow-band imaging (NBI) technology. The colonoscopies will be performed using High Definition monitors. Appropriate and complete bowel preparation before colonoscopy will be ensured using four liters of polyethylene glycol lavage until clear rectal fluid will be evacuated as well as cleaning enema
Sponsors
Instituto de Investigaciones, Fundacion Universitaria Sanitas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years or above with clinical indications for colonoscopy are eligible to enter this trial.
Exclusion criteria
Previous colorectal surgery - Patients with significant family history: Hereditary nonpolyposis colorectal cancer Colorectal cancer or adenomatous polyps in a first-degree relative younger than 60 years, or in two or more first-degree relatives of any age, - Pregnant women - When the risks to patient health or life are judged to outweigh the most favorable benefits of the procedure - When adequate patient cooperation or consent cannot be obtained - When a perforated viscus is known or suspected - Fulminant colitis - Documented acute diverticulitis - Upper GI bleeding or melena with a demonstrated upper gastro intestinal (GI) source - Acute Low GI bleeding - Previous colonoscopy in the last 24 months - Acute diarrhea - Incomplete bowel-cleansing preparation
Outcome results
None listed