Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial

Conditions
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Performance and Tolerance of Colonoscopy

Intervention / Treatment
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* Device: ColoWrap


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction