Clinical trial NCT02025504: Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
Official title: Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance and Tolerance of Colonoscopy
Keywords: Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction
Lead sponsor: ColoWrap, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2014-01-01
Enrollment: 350
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Mean colonoscopic insertion time
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Secondary outcomes:
measure: Frequency of use of ancillary maneuvers
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
measure: Frequency of prolonged, difficult cases
timeFrame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
measure: Drug and Dosage Required to Complete Procedure
timeFrame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
measure: Colonoscopy Completion Rate
timeFrame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
measure: Time to patient discharge
timeFrame: From time point in which scope is removed from patient's rectum following a colonoscopy until the time the patient is discharged from the facility
measure: Operator perception of patient discomfort
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
measure: Patient Pain, Bloating, and Satisfaction at Discharge
timeFrame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility
measure: Operator's Assessment of Procedural Difficultly
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
measure: Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Other outcomes:
measure: Patient Assessment of Intra-Procedural Pain
timeFrame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Meadowmont Endoscopy Center
state: North Carolina
city: Hillsborough
country: United States
facility: UNC Hillsborough Endoscopy Center
state: North Carolina
Study officials:
affiliation: Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC
name: Seth D Crockett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crockett S, Dellon ES, Biggers L, Ernst DA. Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial. Gastroenterol Nurs. 2021 Mar-Apr 01;44(2):136-145. doi: 10.1097/SGA.0000000000000550.
citation: Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.