Detection in Tandem Endocuff Cap Trial

Not Applicable

Completed

• Conditions: Colonic Neoplasms; Colon Adenoma; Adenomas Serrated; Colo-rectal Cancer
• Interventions: Device: Endocuff; Device: cap assisted colonoscopy (CAC)

• Registration Number: NCT03254498
• Lead Sponsor: London North West Healthcare NHS Trust

Brief Summary

A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2017-08
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Study First Posted: 2017-08-18
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Age 18 years and over
2. Referral for surveillance, or diagnostic colonoscopy
3. Ability to give informed consent

Exclusion Criteria

1. Absolute contraindications to colonoscopy
2. Established or suspicion of large bowel obstruction or pseudo-obstruction
3. Known colon cancer or polyposis syndromes
4. Known colonic strictures
5. Known severe diverticular segment (that is likely to impede colonoscope passage)
6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff assisted colonoscopy	Endocuff	Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
Cap assisted colonoscopy	cap assisted colonoscopy (CAC)	Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.

Primary Outcome Measures

Name	Time	Method
Adenoma miss rate	1 day	Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E

Secondary Outcome Measures

Name	Time	Method
Mean adenoma per procedure	1 day	Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
miss rate of advanced polyps	1 day	Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC
Endocuff or cap exchange	1 day	Number of times Cap or Endocuff are removed to complete the procedure
Ceacal intubation and withdrawal time	1 day	Comparison of caecal intubation and withdrawal time
Comfort score	1 day	Comparison of patient comfort score between CAC and EAC

Trial Locations

Locations (1)

NorthWest London Hospitals - NOrthwick park hospital; 🇬🇧 Harrow, Middlesex, United Kingdom