Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

Performance and Tolerance of Colonoscopy Clinical Trial

— C3PO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025504
• Other study ID #: ColoWrap-002
• Status: Completed
• Phase: N/A
• First received: December 28, 2013
• Last updated: March 31, 2015
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: ColoWrap, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Performance and Tolerance of Colonoscopy

Intervention

Device:
• ColoWrap
ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	UNC Meadowmont Endoscopy Center	Chapel Hill	North Carolina
United States	UNC Hillsborough Endoscopy Center	Hillsborough	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
ColoWrap, LLC	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes