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

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.

Study Overview

• Status: Completed
• Conditions: Performance and Tolerance of Colonoscopy
• Intervention / Treatment: Device: ColoWrap

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Hospitals
    • Chapel Hill, North Carolina, United States, 27517
      • UNC Meadowmont Endoscopy Center
    • Hillsborough, North Carolina, United States, 27278
      • UNC Hillsborough Endoscopy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ColoWrap Intervention Group; Patients randomized to ColoWrap Intervention Group will have the ColoWrap abdominal binder secured firmly around their lower abdomen just prior to colonoscopy.	Device: ColoWrap; ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.; Other Names: ColoWrap abdominal binder; ColoWrap colonoscopy binder; ColoWrap device; ColoWrap binder
Sham Comparator: Sham Group; 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.	Device: ColoWrap; ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.; Other Names: ColoWrap abdominal binder; ColoWrap colonoscopy binder; ColoWrap device; ColoWrap binder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean colonoscopic insertion time	Colonoscopic insertion time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of use of ancillary maneuvers	Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Frequency of prolonged, difficult cases	The frequency of prolonged, difficult cases. Procedures in which the insertion phase is greater than 20 min will be recorded and indicated as such.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Drug and Dosage Required to Complete Procedure	Drug and dosage amount required by patient to complete colonoscopy.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Colonoscopy Completion Rate	Colonoscopy completion rate. Dichotomous outcome indicating if the procedure was incomplete or complete.	During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Time to patient discharge	Time to discharge, defined as the time from withdrawal of the colonoscope to patient discharge from the endoscopy unit.	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
Operator perception of patient discomfort	Immediately following completion of procedure, ColoWrap study assistant will obtain operator perception of patient discomfort during procedure according to the Gloucester score	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Patient Pain, Bloating, and Satisfaction at Discharge	The ColoWrap study assistant will interview patient just prior to discharge and obtain responses for pain and bloating according to 10-point visual analog scales, and global satisfaction according to a 5-point scale.	At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility
Operator's Assessment of Procedural Difficultly	Immediately following completion of procedure, the study assistant will obtain the operator's assessment of procedural difficulty and level of physical fatigue according to 5-point scales.	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure	The study assistant will ask the endoscopy technician if they experienced pain during the procedure in any of the following four anatomical sites: lower back, upper back, neck, or upper extremities (right and left shoulder, arm, wrist, hand, fingers). This frequency data will be dichotomous.	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Intra-Procedural Pain	For patients undergoing colonoscopy with conscious sedation, the study assistant will also obtain a response for intra-procedural pain, using a validated measure of procedural comfort.	During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

Collaborators and Investigators

• Sponsor: ColoWrap, LLC
• Collaborators: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Seth D Crockett, MD, MPH, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 28, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (Estimate): January 1, 2014

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction
• Other Study ID Numbers: ColoWrap-002