Endoscopy, Gastrointestinal
Conditions
Keywords
Colonoscopy, Training Techniques, Endoscopy, Gastrointestinal
Brief summary
The purpose of this study is to identify if performing diagnostic colonoscopy with a small plastic cap attached to the camera will improve performance of colonoscopies by physician trainees.
Detailed description
Training novice endoscopists to perform effective diagnostic colonoscopy is a central objective of Gastroenterology fellowship. Though there is no universal definition of competency, it is traditionally assessed with a combination of objective measures such as volume of procedures and subjective factors such as formal evaluations. As quality measures such as cecal intubation time, cecal intubation rate, and adenoma detection rate gain in importance in clinical practice, they should be increasingly incorporated as objectives into more formalized and objective training methodologies. Indeed, though 140 colonoscopies have been suggested as a rough volume threshold needed for trainees to gain competence, evidence suggests that the number may actually be much higher when taking various objective quality measures into account. Recent attention has turned to various measures to improve trainee performance such as computer simulation and magnetic endoscopy imaging. Along these lines, simple, effective, and economical measures are needed to improve trainee performance. Cap assisted colonoscopy (CAC) is performed with the aid of a transparent inert cap attached to the distal end of the colonoscope. CAC allows close examination of mucosa proximal to flexures and haustral folds and prevents red out when closely approximated against mucosa, aiding in luminal orientation and examination. CAC has been shown to improve cecal intubation time, polyp detection rate, and adenoma detection rate in the hands of experienced practitioners. A handful of studies have also indicated that these benefits also extend to trainees, while another prospective study showed no improvement in cecal intubation rate. The investigators hypothesize that cap assisted colonoscopy will result in significantly improved cecal intubation rate and time, as well as adenoma detection rate, among trainees when compared with standard non cap assisted colonoscopy in a large academic Gastroenterology training program in the United States. The study is a prospective randomized trial of colonoscopies performed at Harris Health System Ben Taub Hospital by all novice endoscopy trainees from July 2015 until enrollment is complete. Novice endoscopy trainees are defined as endoscopists with less than 10 colonoscopies performed by July 2015. All colonoscopies included will be performed by the novice endoscopist under direct supervision of a board certified attending gastroenterologist. Each colonoscopy fulfilling the inclusion criteria will be randomized with equal probability to a cap assisted colonoscopy (CAC) group or a control standard colonoscopy (SC) group.
Interventions
DEVICEDistal Attachment Cap
Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.
Sponsors
Alliance for Academic Internal Medicine
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing colonoscopy by a novice endoscopist
Exclusion criteria
* Age less than 18 years or greater than 90 years. * Pregnancy. * Prior surgical resection of colon or rectum. * Known obstructing colorectal tumors. * Severe hematochezia. * Diverticulitis within 1 month of procedure. * Clinical or radiological evidence of colonic obstruction or megacolon within 1 month of procedure. * Referral for endoscopic mucosal resection. * Unsedated colonoscopies. * Colonoscopies abandoned due to inadequate bowel prep or colonoscopies with Boston bowel prep score \< 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program | Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program | Time from the moment of colonoscope insertion until the appendiceal orifice or ileocecal valve is identified |
| Number of Colonoscopies During Which at Least One Adenoma Was Identified | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program | Proportion of colonoscopies that identify at least one adenoma |
| Number of Colonoscopies During Which at Least One Polyp Was Identified | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program | Proportion of colonoscopies that identify at least one polyp |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cap Assisted Colonoscopy The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.
Distal Attachment Cap: Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope. | 110 |
| Standard Colonoscopy Standard colonoscopy without the distal attachment cap is performed in this arm. | 109 |
| Total | 219 |
Baseline characteristics
| Characteristic | Total | Standard Colonoscopy | Cap Assisted Colonoscopy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 017 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants | 92 Participants | 90 Participants |
| Age, Continuous | 55.7 years STANDARD_DEVIATION 9.09 | 55.8 years STANDARD_DEVIATION 9.39 | 55.6 years STANDARD_DEVIATION 8.84 |
| Region of Enrollment United States | 219 Participants | 109 Participants | 110 Participants |
| Sex: Female, Male Female | 147 Participants | 69 Participants | 78 Participants |
| Sex: Female, Male Male | 72 Participants | 40 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 102 |
| serious Total, serious adverse events | 0 / 101 | 0 / 102 |
Outcome results
Primary
Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion
Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.
Time frame: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cap Assisted Colonoscopy | Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion | 80 Participants |
| Standard Colonoscopy | Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion | 67 Participants |
Secondary
Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified
Time from the moment of colonoscope insertion until the appendiceal orifice or ileocecal valve is identified
Time frame: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cap Assisted Colonoscopy | Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified | 13.7 minutes |
| Standard Colonoscopy | Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified | 16.5 minutes |
Secondary
Number of Colonoscopies During Which at Least One Adenoma Was Identified
Proportion of colonoscopies that identify at least one adenoma
Time frame: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cap Assisted Colonoscopy | Number of Colonoscopies During Which at Least One Adenoma Was Identified | 38 Participants |
| Standard Colonoscopy | Number of Colonoscopies During Which at Least One Adenoma Was Identified | 44 Participants |
Secondary
Number of Colonoscopies During Which at Least One Polyp Was Identified
Proportion of colonoscopies that identify at least one polyp
Time frame: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cap Assisted Colonoscopy | Number of Colonoscopies During Which at Least One Polyp Was Identified | 54 Participants |
| Standard Colonoscopy | Number of Colonoscopies During Which at Least One Polyp Was Identified | 55 Participants |