The primary aim of this feasibility study is to determine the quality of bowel cleansing in patients undergoing colonoscopy with the ClearPath system after modified bowel preparation.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Ottawa bowel preparation quality scale during introduction and withdrawing
of the colonoscope.
Secondary outcome
A. Patients tolerance and compliance:
• Acceptability of colon preparation
• Bowel preparation completion rate
• Satisfaction
• Symptoms
• Preferences
B. Colonoscopy results:
• Colonic polyp detection rate
• Other significant findings during colonoscopy
• Successful intubation of the cecum
• Total procedural time
• Total withdrawal time
• Second colonoscopy (or alternative investigating of the colon for example
CT-colonography) indicated?
Background summary
Polyethyleenglycol (PEG) is a non-absorbable, balanced electrolyte solution and
in many clinics including the UMCU the recommended choice of bowel preparation.
PEG does not cause volume shifts or disturbances in serum electrolytes compared
to osmotic or saline laxatives (such as mannitol and NaP) which is especially
important in elderly patients or patients with renal or cardiac disorders. An
important disadvantage of PEG solutions is the amount and taste which
compromises patients* tolerance. A recent meta-analysis reports an excellent
or good quality of preparation in only 77% (34-98%) of the patients receiving
PEG. Approximately 90% of the patients complete the recommended 4L of PEG. More
than one third of the patients receiving PEG experience symptoms of
nausea/vomiting, pain, discomfort or distention.
Poor compliance to bowel preparation instructions is one of the major risk
factors for inadequate bowel preparation. Inadequate bowel cleansing has
several consequences including a lower colonic neoplasm detection rate,
increased complication risk, second colonoscopy and increased procedural time.
To further improve bowel cleansing without lowering patients* tolerance the
ClearPath* Irrigation and Evacuation System (ClearPath system) has been
developed by EasyGlide (Easy-Glide, Ltd., Kefar Truman, Israel). The ClearPath
system is a disposable device which can be attached to the distal end of the
colonoscope and has two channels, one for irrigation and one for evacuation,
which can operate simultaneously. More powerful irrigation and suction with a
larger tube can increase bowel cleansing during colonoscopy and therefore can
improve visualization of the colon mucosa. Furthermore the working channel is
constantly available which can improve visualization during procedures such as
polypectomy. This feasability study will provide clinical experience and
information about the effectiveness of this new system.
Study objective
The primary aim of this feasibility study is to determine the quality of bowel
cleansing in patients undergoing colonoscopy with the ClearPath system after
modified bowel preparation.
Study design
This feasibility study is a single-center study.
Intervention
Modified bowel preparation (2 liter PEG solution compared to the standard 4
liter PEG solution) prior to colonoscopy with the ClearPath* Irrigation and
Evacuation System.
Study burden and risks
"All participants will be exposed to all regular risks of colonoscopy, i.e.,
bleeding, perforation and post-polypectomy syndrome. The study protocol differs
in two major ways from standard colonoscopy:
1. Modified bowel preparation (2 instead of 4LColofort) may result in
inadequate bowel cleansing. The ClearPath system however is able to remove
remaining stool more adequately by more powerful suction and irrigation.
2. The ClearPath system is a new device and not part of standard clinical
practice. Although the ClearPath system increases the diameter of the
colonoscope with 6mm, we expect expect the ClearPath system is unlikely to
cause major harm, when handled with care and according to predetermined
instructions. Although three experienced endoscopists will perform all
colonoscopies, there will likely be a learning curve which may cause a slight
increase in procedural time. Furthermore, the removal of remaining bowel
contents due to modified bowel preparation may also increase procedural time."
The ClearPath system has the potential to be of great advantage in patients
with inadequate bowel preparation. Furthermore a modified bowel preparation
prior to colonoscopy is likely to improve patients* tolerance. We do not expect
clinically significant differences in clinical outcomes. The ClearPath system
has been certified by the FDA in 2010 and approved by the CE in 2009 for upper
and lower endoscopy in humans. This feasability study will provide us with
important information for further studies with the ClearPath system.
postbus 85500
3508 GA Utrecht
NL
postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
• Adults of 18 years or older
• Elective outpatient colonoscopy
• Diagnostic, screening or surveillance colonoscopy
• Written informed consent
Exclusion criteria
• In hospital bowel preparation.
• Known colonic motility disorder e.g. hypothyroidism, chronic idiopathic intestinal pseudo-obstruction.
• Surveillance because of a family history of Lynch syndrome or previous history of inflammatory bowel disease (IBD).
• Scheduled intervention colonoscopy because of a lesion found during previous colonoscopy (for example polypectomy).
• Active IBD (including toxic megacolon).
• Known or suspected bowel disease with an increased risk of complications, for example diverticulitis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34767.041.10 |