Colorectal PolypsNCT01607827
Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?
A study testing Polyp removal upon insertion and withdrawal and Polyp removal upon withdrawal only in people with Colorectal Polyps, run by University of Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Polyp removal upon insertion and withdrawal and Polyp removal upon withdrawal only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Need for a complete colonoscopy
- 18 years of age and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Colorectal Polyps
- Being tested
- Polyp removal upon insertion and withdrawal, Polyp removal upon withdrawal only
- Keywords
- polypectomy, colonoscopy, polyp miss rate, surveillance, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyp removal upon insertion and withdrawalProcedure or surgery
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.
Polyp removal upon withdrawal onlyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Polyp removal upon insertion and withdrawal | Active comparator | Not described Receives: Procedure: Polyp removal upon insertion and withdrawal |
| Polyp removal upon withdrawal only | No intervention | Not described Receives: Procedure: Polyp removal upon withdrawal only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection
Measured: 2004 - 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startApr 2004
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Wildi, University of Zurich
- Investigators
- Stephan M. Wildi, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607827
- Sponsor's protocol ID
- EK-1066
- Status last verified
- Jun 2012
- First submitted
- 24 May 2012
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?
- ClinicalTrials.gov ID
- NCT01607827
- Acronym / sponsor ID
- EK-1066
- Conditions
- Colorectal Polyps
- Keywords
- polypectomy, colonoscopy, polyp miss rate, surveillance, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyp removal upon insertion and withdrawal | Active comparator | Procedure: Polyp removal upon insertion and withdrawal |
| Polyp removal upon withdrawal only | No intervention | Procedure: Polyp removal upon withdrawal only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Need for a complete colonoscopy
- 18 years of age and older
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyp removal upon insertion and withdrawalEndoscopic 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. | Procedure or surgery | Polyp removal upon insertion and withdrawal |
| Polyp removal upon withdrawal onlyEndoscopic 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. | Procedure or surgery | Polyp removal upon withdrawal only |
Primary outcome
Polyp detection
Time frame: 2004 - 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan M. Wildi, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyp removal upon insertion and withdrawal and Polyp removal upon withdrawal only in people with Colorectal Polyps, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp detection (time frame: 2004 - 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.