Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

Completed · Not applicable · Has a placebo group

Conditions studied: Performance and Tolerance of Colonoscopy

In brief

Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and impact patient experience and tolerance. The investigators propose to evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome will be time to distal extent (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.

Key facts

Study ID

NCT02025504

Run by

ColoWrap, LLC

People needed

350

Starts

2014-04-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-03

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adults between the ages of 40 - 80
• Undergoing a colonoscopy at any of the study locations for:
• i. CRC screening (first colonoscopy or 10 year follow up of negative exam). ii. Surveillance (prior colonoscopy with polyps). iii. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.
• Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
• For the purposes of informed consent, participants must be able to understand and read English.

You may not qualify if…

• Inability to provide informed consent
• Active or suspected pregnancy
• Patients referred due to incomplete colonoscopy or for removal of difficult polyps
• History of problems with sedation or anesthesia -. Participants electing to be unsedated for colonoscopy
• Patients undergoing multiple procedures (e.g. upper and lower endoscopy)
• Previous colon resection surgery
• Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
• Patients with a history of colorectal cancer or other intra-abdominal malignancy.
• Patients with open or recent wounds or skin rash on the anterior abdominal wall.
• History of cirrhosis or ascites
• Known ventral or umbilical hernia
• Patients who are medically unstable(American Society of Anesthesiology Class III or above).

Where it is running

• UNC Hospitals — Chapel Hill, North Carolina, United States
• UNC Meadowmont Endoscopy Center — Chapel Hill, North Carolina, United States
• UNC Hillsborough Endoscopy Center — Hillsborough, North Carolina, United States

Full record on ClinicalTrials.gov

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