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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Switzerland1 site
  • University of Zürich

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

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).

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 groups in NCT01607827
Study groupRoleWhat they receive
Polyp removal upon insertion and withdrawalActive comparatorNot described
Receives: Procedure: Polyp removal upon insertion and withdrawal
Polyp removal upon withdrawal onlyNo interventionNot 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.

  1. 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.

  1. First posted30 May 2012 (estimated)
  2. Study startApr 2004
  3. Primary completionMar 2007
  4. Study completionApr 2007

Resources

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)
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

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.

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