Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study (C3PO)

ColoWrap

Status: Completed

Conditions: Performance and Tolerance of Colonoscopy

Treatments: Device: ColoWrap

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02025504

ColoWrap-002

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups

ColoWrap Intervention Group

Experimental group

Description:

Patients randomized to ColoWrap Intervention Group will have the ColoWrap abdominal binder secured firmly around their lower abdomen just prior to colonoscopy.

Treatment:

Device: ColoWrap

Sham Group

Sham Comparator group

Description:

Sham Group will also have a ColoWrap binder placed around their lower abdomen, but it will be placed loosely so no appreciable lower abdominal pressure is generated by the device.

Treatment:

Device: ColoWrap