Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy

Not Applicable

Withdrawn

• Conditions: Colorectal Neoplasms
• Interventions: Device: Standard Colonoscopy; Device: Device Assisted Colonoscopy

• Registration Number: NCT02504411
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Study Start: 2015-08
• Primary Completion: 2017-02
• Study Completion: 2017-02-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients undergoing first screening colonoscopy
2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
3. Ability to provide informed consent.

Exclusion Criteria

1. Previous surgical resection of any part of the colon
2. history of colon cancer
3. history of inflammatory bowel disease
4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps
5. Poor general condition
6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
7. Inability to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Colonoscopy	Standard Colonoscopy	Standard colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus.
Device Assisted Colonoscopy	Device Assisted Colonoscopy	Device assisted colonoscopy (DAC) is a technique of attaching disposable devices like "Endocuff" or "Transparent cap" at tip of colonoscope to improve mucosal visualization and stability.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate (ADR) as determined by Colonoscopy	intraoperative
Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy	intraoperative

Secondary Outcome Measures

Name	Time	Method
Cecal Intubation Rate (CIR)	intraoperative

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States