Full Spectrum Endoscopy (FUSE) colonoscopy versus conventional forward-viewing colonoscopy in the detection of dysplasia in patients with chronic inflammatory bowel diseases .

Not Applicable

Recruiting

• Conditions: inflammatory bowel diseases; colorectal cancer; Oral and Gastrointestinal - Inflammatory bowel disease; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12616000047493
• Lead Sponsor: Concord Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

18-80 years
Eligible for inclusion into the IBD Surveillance Program according to the NHMRC guidelines - that is patients with colitis (at least 1/3 extent of the bowel) of at least 8 years duration.
Those with concurrent primary sclerosing cholangitis or prior colonic dysplasia are eligible immediately (rather than at 8 years)

Exclusion Criteria

Prior colonoscopy surveillance procedure within the past 12 months (or within 2 years for low-risk cases).
Adverse effects or contraindications to methylene blue chromoendoscopy (dye spray into the bowel is standard surveillance procedure during surveillance).
Pregnancy
Lactation
Severe comorbidities
Prior colon resection (apart from limited caecal resection as part of ileal resection)
Active inflammatory colitis (preventing adequate chromoendoscopy)
Unable to complete colonoscopy (failure or poor bowel preparation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dysplasia miss rates on a per-lesion analysis [Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures. ]

Secondary Outcome Measures

Name	Time	Method
Dysplasia identification on a per-patient analysis. [Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures. ];The mean number of dysplastic lesions found on FVC versus FUSE[Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures. ];The procedural insertion and withdrawal times[Following completion of both colonoscopies and calculation of the time taken to perform each of the colonoscopies. ];The yield of dysplasia of targeted biopsies compared against random biopsies with- and without chromoendoscopy[Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures. ];Complication rate comparing conventional colonoscopy with FUSE. Assessing complications such as abdominal pain or need for readmission to hospital. [30-days after the the procedure based on a telephone call to the subject.]