We hypothesized that bowel preparation will be comparable between groups as measured using the Boston Bowel Preparation Scale and that the adenoma detection rate will be comparable across groups. Furthermore, we hypothesized that patient experience…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patienten die opgenomen worden voor klinische voorbereiding voor een colonoscopie, ongeacht aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures for this study are the quality of bowel
preparation measured using the Boston Bowel Preparation Scale (BBPS), amount of
preparatory regimen received on the ward, and adenoma detection rate.
The BBPS is a validated scale which applies a four-point scoring system to each
of the three regions of the colon, namely the right colon (including cecum and
ascending colon), the transverse colon (including the hepatic and splenic
flexures), and the left colon (including the descending colon, sigmoid colon
and the rectum). A score of 0 is assigned to an unprepared colon segment with
mucosa that was not seen due to solid stool which was unable to be cleared. A
point of 1 is assigned to mucosa which can be partially seen, where a portion
of the mucosa segment was observed, but other areas of the colon segment could
not be seen due to staining, residual stool and/or opaque liquid. A score of 2
is attributed when a minor amount of residual staining is present, with small
fragments of stool and/or opaque liquid, but the mucosa of the colon segment
was able to be seen well. Finally, a score of 3 is accredited to bowel
preparation in which the entire mucosa of the colon segment is seen well, with
no residual staining, small stool fragments or opaque liquid. Each region as
described above receives a score between 0 and 3 and are summed to a total BBPS
score ranging between 0 and 9 (Lai et al 2009).
Adenoma detection rates are determined according to diagnosis by pathological
evaluation. Adenomas will be classified following the guidelines of the
European Society of Gastrointestinal Endoscopy (ESGE). The adenoma detection
rate is defined as the proportion of patients with diagnosis of at least one
adenomatous lesion. Polyp detection rate will also be recorded, as well as the
number of polyps removed during endoscopy.
Secondary outcome
Secondary outcome measures are: kidney function measured using blood tests,
cecal intubation, the amount of preparatory regimen required in Liters, adverse
side-effects (including disturbed sleep), patient rating of their experience
with the preparatory regimen, the need for a nasal gastric tube, and the amount
of laxative regime required
Cecal intubation will be noted at endoscopy and recorded as an outcome measure
to evaluate the quality of colonoscopy. Furthermore, patient experience of the
bowel preparation will be assessed using a questionnaire administered following
endoscopy at the first following out-patient visit. Patients will grade their
experience of bowel preparation, and will be asked to report on any adverse
events experienced, as well as disturbed sleep during the bowel preparation
period. Furthermore, kidney function will be assessed using blood tests before
and after drinking of the preparatory regimen.
The amount of preparatory regimen required for adequate bowel cleansing, as
evaluated by an experienced ward nurse, will be analysed and compared across
intervention groups. Furthermore, if patients required administration of the
preparatory regimen via a nasal-gastric tube, this will also be included as a
secondary outcome parameter. Finally, blood tests will be performed before and
after bowel preparation and colonoscopy, to evaluate kidney function and
electrolytes, confirming that no significant change occurs in either parameter.
Background summary
Adequate bowel preparation is essential for optimal inspection of the colon
during colonoscopy. Bowel lavage is used as colon cleansing preparation for
diagnostic, as well as therapeutic intervention during endoscopy procedures by
a gastroenterologist. However, optimal bowel cleansing is also essential for
diagnosis by radiologists and required for certain surgical interventions (Di
Palma, 1998).
Currently, the majority of bowel preparation occurs using large volume oral
solutions. The most commonly applied lavage agents are polyethylene glycol
(PEG) electrolyte solutions, and sodium phosphate lavage solutions
(Parra-Blanco 2014). Such solutions are isotonic and electrolyte balanced,
allowing for little change in patient hydration and electrolytes despite the
large volume consumed (Davis 1980, Fordtran 1990). Adequate bowel preparation
may require up to 4 liters of lavage liquid to be ingested, resulting in
numerous patient complaints regarding the volume of disagreeable tasting
solution that patients are required to drink (Clark LE 2004).
Sulfate is an anion which is poorly absorbed and has historically been used as
an osmotic agent for laxative effect as well as large volume bowel lavage
(Davis 1980). This basis was used to develop a new sulfate based lavage agent
known as SUPREP in which stool volumes are generated in normal volunteers that
are equivalent to sodium phosphate preparations, and do not significantly alter
fluid and electrolyte balances (DiPalma 2009). Di Palma et al 2009 showed that
a new low-volume oral sulfate solution known as SUPREP was equivalent to bowel
preparation with PEG solution with ascorbic acid, showing that either was
suitable to use for preparation before colonoscopy (DiPalma 2009).
The importance of adequate bowel preparation at endoscopy cannot be
understated. The quality of bowel preparation directly influences two major
indices of endoscopy quality, namely cecal intubation rate and adenoma
detection rate (Harewood 2003). Furthermore, inadequate bowel preparation
results in lower detection rates of incipient and advanced adenomas, as well as
flat lesions or adenomas (Harewood 2003, Choski 2012, Parra-Blanco 2006, Chiu
2011) . Concurrently an inefficiently prepared bowel leads to higher
cancellation rates of procedures, increased costs, lengthier time of procedures
and a higher risk of complications (Jones 2010 & Jover 2013).
Study objective
We hypothesized that bowel preparation will be comparable between groups as
measured using the Boston Bowel Preparation Scale and that the adenoma
detection rate will be comparable across groups. Furthermore, we hypothesized
that patient experience will be reported as more positive in the group
receiving the sulfate based regimen for bowel preparation, considering the
lower volume of split-dose preparation involved. Therefore, this study
primarily will compare the efficacy of two types of bowel preparation for
colonoscopy: a polyethylene glycol regimen (Clean-Prep) with bisacodyl and
supportive sennoiside treatment versus a sulfate based regimen (SUPREP) on its
own without bisacodyl. A secondary study aim which will be examined is the
patient experience and evaluation of bowel preparation comparing the two
preparation regimens.
Study design
We propose a single-center randomized controlled trial in which 200 patients
will be randomly divided into two intervention groups: bowel preparation for
colonoscopy with a polyethylene glycol regimen (Clean-Prep) with bisacodyl and
supportive sennoiside treatment versus a sulfate based regimen (SUPREP) on its
own without bisacodyl.
All patients seen at the gastroenterology outpatient clinic of the
Elisabeth-TweeSteden Hospital in Tilburg who are planned for hospital admission
to aid in preparation for bowel cleansing for colonoscopy will be eligible for
inclusion. All included patients will be randomly allocated to 100 in each
intervention group using electronic randomization software following which an
anonymous code will be granted to each study participant.
Patients who receive polyethylene glycol preparation will receive a split
dosage of 4L (4x1L) of Colofort with 10 mg bisacodyl and 1ml/kg sennoiside
syrup. Patients who receive the sulfate regimen, will receive a split dose of
1L (2x 0.5L) of SUPREP. If a patient is not adequately prepared for colonoscopy
extra split dosages will be administered until the patient is deemed
sufficiently clean for colonoscopy by the ward nurses.
Intervention
Patients who receive polyethylene glycol preparation will receive a regimen
according to standard care in the Elisabeth-TweeSteden Hospital at the
Gastroenterology Ward. The regimen is as follows: following admission to the
hospital ward, patients will receive 1ml/kg of sennoiside syrup with a maximum
dosage of 75 ml. Approximately 2 hours later, 1 Liter Kleanprep will be
provided, after which, 1 hour later another 1 Liter of Kleanprep will be
provided for oral administration. A final dose for that day of 1 Liter
Kleanprep will be provided 3 hours following the 2nd administration. At 22.00
in the evening, 2x5mg tablets of bisacodyl are administered. The following day
the final dose of 1 Liter Kleanprep is provided in the morning. In case the
patient is still not deemed adequately prepared by an experienced ward nurse,
an additional 1 Liter Kleanprep will be provided each hour, until 2 hours prior
to colonoscopy until a maximum of 14 Liters.
Patients who are allocated to the oral sulfate regimen group will receive a
split dose of 1L (2x 0.5L) of OSS, after which patients will be stimulated to
drink an extra 2 liters of a clear liquid of choice. Upon hospital admission,
patients will receive the first dose of 500ml OSS. After ingestion of the 500
ml, patients will be asked to ingest a further 2 Liters of liquid of their
choice, providing it is a clear liquid, such as water, apple juice or tea. The
following day, the day of colonoscopy, patients will receive the second split
dose, in the same manner. If a patient is not adequately prepared for
colonoscopy, as determined by an experienced ward nurse, an extra split dosage
will be administered, with an additional 500ml, followed by 2 Liters of clear
liquid, until 2 hours prior to colonoscopy, with a maximum total dose of 2
liters of OSS, with 8 Liters of clear liquid supplementation.
Study burden and risks
This research will only include patients who will be admitted for preparation
for colonoscopy regardless of participation in the trial. No extra risks or
burdens are associated with participation.
The benefit of participation is the possible reduced risk of a second
colonoscopic procedure in the case of an inadequately prepared bowel.
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
All adults (> 18 years of age) seen at the outpatient clinic to be admitted for planned preparation for colonoscopy at the Elisabeth-TweeSteden Hospital in Tilburg were eligible for inclusion in this study.
Exclusion criteria
Gastro-intestinal obstruction
Bowel perforation
Gastric outlet obstruction
Toxic colitis or toxic megacolon
Hyperemesis
Severe dehydration
Congestive heart failure
Ascites
Severe kidney insufficientie (GFR < 30ml/min/1,73 m2)
Active inflammatory bowel disease (morbus Crohn, ulcerative colitis)
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 |
|---|---|
| EudraCT | EUCTR2017-000060-15-NL |
| CCMO | NL60456.028.17 |