Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 3/16/2015 |
| Start Date: | April 2014 |
| Contact: | Seth D Crockett, MD, MPH |
| Email: | seth_crockett@med.unc.edu |
| Phone: | 919-962-2608 |
Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial
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.
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.
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).
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