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Completed

NCT Number: NCT02025504

Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

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.

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Key information

Conditions

Performance and Tolerance of Colonoscopy Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals, Chapel Hill, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ColoWrap

Device

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

Other names: ColoWrap abdominal binder, ColoWrap colonoscopy binder, ColoWrap device, ColoWrap binder

Primary outcomes

  1. Mean colonoscopic insertion time

    Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

    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

Secondary outcomes

  1. Frequency of use of ancillary maneuvers

    Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

    Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.

  2. Frequency of prolonged, difficult cases

    Time frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum

    The frequency of prolonged, difficult cases. Procedures in which the insertion phase is greater than 20 min will be recorded and indicated as such.

  3. Drug and Dosage Required to Complete Procedure

    Time frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum

    Drug and dosage amount required by patient to complete colonoscopy.

  4. Colonoscopy Completion Rate

    Time frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum

    Colonoscopy completion rate. Dichotomous outcome indicating if the procedure was incomplete or complete.

  5. Time to patient discharge

    Time frame: 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

    Time to discharge, defined as the time from withdrawal of the colonoscope to patient discharge from the endoscopy unit.

  6. Operator perception of patient discomfort

    Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

    Immediately following completion of procedure, ColoWrap study assistant will obtain operator perception of patient discomfort during procedure according to the Gloucester score

  7. Patient Pain, Bloating, and Satisfaction at Discharge

    Time frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility

    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.

  8. Operator's Assessment of Procedural Difficultly

    Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

    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.

  9. Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure

    Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

    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.

Other outcomes

  1. Patient Assessment of Intra-Procedural Pain

    Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

    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.

Sponsors and collaborators

Lead sponsor

ColoWrap, LLC

Industry

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: C3PO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2014
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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