Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?
Primary Purpose
Colorectal Polyps
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Polyp removal upon insertion and withdrawal
Polyp removal upon withdrawal only
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Polyps focused on measuring polypectomy, colonoscopy, polyp miss rate, surveillance, colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- Need for a complete colonoscopy
- 18 years of age and older
Exclusion Criteria:
- Need for urgent colonoscopy due to bleeding
- High likelihood of colonic stenosis or severe inflammation
- Known inflammatory bowel disease (IBD)
- Known familiarity adenomatous polyposis (FAP)
- Contraindications for polypectomy such as coagulopathy, use of anti-clotting medication (anticoagulation, aspirin, NSAIDs)
- Missing signed consent
Sites / Locations
- University of Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Polyp removal upon insertion and withdrawal
Polyp removal upon withdrawal only
Arm Description
Outcomes
Primary Outcome Measures
Polyp detection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01607827
Brief Title
Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?
Official Title
Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to assess the procedure time and miss rate of polyps when performing polypectomy in the colon on the way up* and down** or only on the way down**.
(* advancing the scope to the cecum, ** pulling back the scope after intubation of the cecum). Our hypothesis is that using the strategy to remove all visible polyps firstly on the way up and secondly on the way down is less time consuming and misses less polyps as with the strategy to remove polyps only on the way down.
Detailed Description
Patients with a referral for a complete colonoscopy were included in the study. Polyps were removed upon insertion and withdrawal of the colonoscope in Group A or only upon withdrawal of the instrument in Group B according to a computer-generated randomization list.
The following inclusion criteria were used: referral for a complete colonoscopy and age of 18 years and older. All patients with polyps detected during colonoscopy were included. In order to compare the time required for the entire endoscopy between the two treatment groups, we only included patients with polyps of up to 10 mm in diameter.
The following exclusion criteria were applied: colonoscopy due to bleeding, high likelihood of colonic stenosis or severe inflammation, inflammatory bowel disease (IBD), hereditary colonic polyp disease (FAP or HNPCC), contraindications for polypectomy, such as coagulopathy, use of anti-clotting medication (anticoagulation, high-dose heparin aspirin, NSAIDs), polyps >10 mm in diameter (that cannot be removed through the biopsy channel and have to be removed by basket or polyp grasper; the use of these devices necessitates removal and consecutive re-insertion of the endoscope, making a comparison of the time intervals between the two groups impossible), suboptimal bowel preparation (presence of significant amounts of fecal remnants that could not be removed by flushing of the colon over the colonoscope and that did not allow clear visualization of the mucosa), and missing signed informed consent form.
The randomization was done as soon as the first polyp was detected. When no polyps were detected, the case was regarded as screening failure and excluded from the study.
Randomization was performed into the following two groups:
Group A: Removal of all visible polyps upon insertion and withdrawal of the instrument Group B: Removal of all visible polyps upon withdrawal of the colonoscope only One day after colonoscopy, patients were asked to complete a questionnaire evaluating the tolerance of the ileo-colonoscopy (on a visual scale from 1 to 4 where 1 stands for no discomfort, 2 for minor discomfort, 3 for moderate discomfort, and 4 for severe discomfort associated with the endoscopy).
Endoscopic procedures:
Colon preparation was performed using 3 liters of PEG-based standard lavage fluids (Fordtran Streuli ®, Streuli Pharma, Switzerland).
The procedures were performed by senior endoscopists (SW, SRV, HF, NW, PB) with at least 5 years of experience in colonoscopy and performing at least 200 colonoscopies per year. All endoscopists participating in this trial underwent a specific study training headed by SW. Polyp size was measured using an opened biopsy forceps (Boston Scientific Radial JawTM 4, Reference No 1332, diameter of opened jaws 9mm). All endoscopists had comparable numbers of procedures in both approaches to polypectomy.
Premedication consisted mostly of propofol (60-400 mg) or a combination of midazolam (2.5-5 mg) and/or meperidine (25-50 mg) intravenously. Examinations were performed in left lateral decubitus or supine position. Colonic insufflation was performed with room air. All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.
In Group A, the endoscopist removed all visible polyps instantly regardless whether advancing the instrument to the cecum or pulling back. In Group B, the endoscopist advanced the endoscope to the cecum without removing polyps. Upon withdrawal, all visible polyps were removed successively by standard techniques. In both groups, the endoscopists were instructed to focus on rapid introduction.
Assessments After the endoscopy, the physician completed the data capture sheet evaluating the following criteria: patient demographics, patient history, time intervals required for the procedure, number of polyps detected upon insertion, number of polyps removed upon insertion, number of polyps removed upon withdrawal, overall technical ease (score from 1 to 4 where 1 stands for no technical problems, 2 for minor, 3 for moderate, and 4 for major technical difficulties), presence of technical problems (difficult visualization of the polyps, difficult removal of polyps, and difficult retrieval of polyps, all answered categorically with "Yes" or "No"), patient tolerance (completed by patients), and characterization of every polyp (location, size, time of removal and additional comments).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyps
Keywords
polypectomy, colonoscopy, polyp miss rate, surveillance, colorectal cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyp removal upon insertion and withdrawal
Arm Type
Active Comparator
Arm Title
Polyp removal upon withdrawal only
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Polyp removal upon insertion and withdrawal
Intervention Description
Endoscopic procedures:
All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.
The endoscopist removed all visible polyps instantly regardless whether advancing the instrument to the cecum or pulling back.
Intervention Type
Procedure
Intervention Name(s)
Polyp removal upon withdrawal only
Intervention Description
Endoscopic procedures:
All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.
The endoscopist advanced the endoscope to the cecum without removing polyps. Upon withdrawal, all visible polyps were removed successively by standard techniques.
Primary Outcome Measure Information:
Title
Polyp detection
Time Frame
2004 - 2007
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Need for a complete colonoscopy
18 years of age and older
Exclusion Criteria:
Need for urgent colonoscopy due to bleeding
High likelihood of colonic stenosis or severe inflammation
Known inflammatory bowel disease (IBD)
Known familiarity adenomatous polyposis (FAP)
Contraindications for polypectomy such as coagulopathy, use of anti-clotting medication (anticoagulation, aspirin, NSAIDs)
Missing signed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan M. Wildi, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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