Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

NCT ID: NCT02025504

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Performance and Tolerance of Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ColoWrap

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

ColoWrap

Intervention Type: DEVICE

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

Interventions

ColoWrap

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

Intervention Type: DEVICE

Other Intervention Names

ColoWrap abdominal binder; ColoWrap colonoscopy binder; ColoWrap device; ColoWrap binder

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

ColoWrap, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seth D Crockett, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC

Locations

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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33795622 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26767313 (View on PubMed)

Other Identifiers

ColoWrap-002

Identifier Type: -

Identifier Source: org_study_id