Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

N/ACompletedNCT02025504

ColoWrap, LLC350 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

350

Conditions

Performance and Tolerance of Colonoscopy

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

Time frame: 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.

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 Required to Complete Procedure

Drug and dosage amount required by patient to complete colonoscopy.

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

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

Time frame: 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.

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

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes