Assessing the additional benefit of an innovative imaging system for colonoscopy

Conditions

1. Colorectal cancer 2. Colorectal adenomas Cancer 1. Colorectal cancer 2. Colorectal adenomas

Hassan C, Senore C, Manes G, Fuccio L, Iacopini F, Ricciardiello L, Anderloni A, Frazzoni L, Ballanti R, de Nucci G, Colussi D, Redaelli D, Lorenzetti R, Devani M, Arena I, Grossi C, Andrei F, Balestrazzi E, Sharma P, Rex DK, Repici A.

2018-10-2423 citations

10.1016/j.gie.2018.10.019

Full-spectrum (FUSE) versus standard forward-viewing colonoscopy in an organised colorectal cancer screening programme

Cesare Hassan, Carlo Senore, Franco Radaelli, Giovanni de Pretis, Romano Sassatelli et al. (19 authors)

Gut2016-08-0983 citations

10.1136/gutjnl-2016-311906

Interventions

Patients are randomly allocated into two groups, who will each undergo a colonoscopy. For patients in the first group, a standard white light HD endoscope (Standard Forward View) is used, and for pati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consecutive patients aged 50 to 69 years undergoing their first colonoscopy examination in the participating centers following a positive fecal immunochemical test (FIT) performed in the context of a regional mass-screening program.

Exclusion criteria

Exclusion criteria: 1. Personal history of colorectal cancer or advanced adenoma 2. More than one first degree relative with colorectal cancer 3. Inflammatory bowel disease (IBD) 4. Endoscopy within past 5 years

Design outcomes

Primary

Measure	Time frame
1. Additional yield of advanced adenomas in patients when using Fuse as compared to SFV 2. Proportion of patients detected with 3 or more adenomas when using Fuse as compared to SFV	—

Secondary

Measure	Time frame
1. Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas detection rate of the two techniques, determined from the information recorded in endoscopist and pathology reports 2. Comparison of the size of multiple lesions detected by the two methods, determined from the information recorded in endoscopist and pathology reports 3. Comparison of the detection rate of neoplasia by colonic site: distal (rectum, sigmoid and descending colon) and proximal (proximal to the descending colon), determined from the information recorded in endoscopist and pathology reports 4. Differences in the surveillance guidelines post-colonoscopy when comparing the two arms, determined from the information recorded in endoscopist and pathology reports 5. Comparison of the time required to reach the cecum, determined from the information recorded in endoscopist and pathology reports 6. Comparison of the withdrawal and total procedure time, determined from the information recorded in endoscopist and pathology reports 7. Assessing the learning curve of participating endoscopists, determined from the information recorded in endoscopist and pathology reports 8. Assessing patient’s experience, measured using a questionnaire administered at the end of the examination 9. Assessing the specific contribution of the additional view estimating the proportion of polyps detected using the additional views only, determined from the information recorded in endoscopist and pathology reports	—

Measure

Time frame

1. Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas detection rate of the two techniques, determined from the information recorded in endoscopist and pathology reports 2. Comparison of the size of multiple lesions detected by the two methods, determined from the information recorded in endoscopist and pathology reports 3. Comparison of the detection rate of neoplasia by colonic site: distal (rectum, sigmoid and descending colon) and proximal (proximal to the descending colon), determined from the information recorded in endoscopist and pathology reports 4. Differences in the surveillance guidelines post-colonoscopy when comparing the two arms, determined from the information recorded in endoscopist and pathology reports 5. Comparison of the time required to reach the cecum, determined from the information recorded in endoscopist and pathology reports 6. Comparison of the withdrawal and total procedure time, determined from the information recorded in endoscopist and pathology reports 7. Assessing the learning curve of participating endoscopists, determined from the information recorded in endoscopist and pathology reports 8. Assessing patient’s experience, measured using a questionnaire administered at the end of the examination 9. Assessing the specific contribution of the additional view estimating the proportion of polyps detected using the additional views only, determined from the information recorded in endoscopist and pathology reports

—

Countries

Italy

Outcome results

None listed