ORIGINAL ARTICLE
Small Bowel Preparations for Capsule Endoscopy
With Mannitol and Simethicone
A Prospective, Randomized, Clinical Trial
Hong-bin Chen, PhD, MD,* Yue Huang, MD,* Su-yu Chen, MD,w Hui-wen Song, MD,*
Xiao-lin Li, MD,* Dong-lin Dai, MD,z Jia-tia Xie, MD,* Song He, MD,y Yuan-yuan Zhao, MD,*
Chun Huang, MS,* Sheng-jun Zhang, MD,* and Lin-na Yang, MD*
Background and Objective: There is no consensus concerning small
bowel preparation before capsule endoscopy (CE). This study
evaluated the effects of 4 regimens on small bowel cleansing and
diagnostic yield.
Methods: Patients were randomly divided into 4 groups. Group A
consumed a clear liquid diet after lunch on the day before CE,
followed by overnight fasting. Group B took 250 mL 20%
mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of
the procedure. In group C, the same regimen was taken at 20:00
hours on the day before and at 05:00 hours on the day of CE.
In group D, in addition to the group C regimen, 20 mL oral
simethicone was taken 30 minutes before CE.
Results: Two hundred patients were prospectively enrolled, and
7 were excluded from the final analysis because of incomplete small
bowel transit. No significant difference was noted among the
4 groups for small bowel transit time. Bowel preparation in group
D was significantly better than for the other regimens for overall
cleansing of the proximal small bowel, and showed improved
overall cleansing of the distal small bowel when compared with
10-hours overnight fasting. Pathological lesions of the proximal
and distal small bowel were, respectively, achieved in 82 and 74
patients, mostly distributed in group D.
Conclusions: Small bowel preparation that involves split-dose oral
mannitol plus single-dose simethicone for CE can improve mucosal
visualization and subsequent diagnostic yield when compared with
10-hours overnight fasting.
Received for publication February 12, 2010; accepted July 7, 2010.
From the *Department of Gastroenterology, Sanming First Affiliated
Hospital of Fujian Medical University, Sanming; wDepartment of
Gastroenterology, First Affiliated Medical College of Wuhan
University, Renmin Hospital of Wuhan University, Wuhan;
zInternal Department, Shenzhen Children’s Hospital, Shenzhen;
and yDepartment of Gastroenterology, The Second Affiliated
Hospital of Chongqing Medical University, Chongqing, China.
Conflict of Interest: None of the authors of this manuscript have any
relevant financial disclosures or conflicts of interest to state. There
are no personal, financial, or other relevant relationships with
OMOM Diagnostic system of capsule endoscopy.
Source of Support: None.
Specific author contributions: Hong-bin Chen, Yue Huang, Hui-wen
Song, Yuan-yuan Zhao, and Dong-lin Dai initiated the study
design; Hong-bin Chen, Hui-wen Song, Yue Huang, Song He, Jia-
tai Xie, Chun Huang, and Sheng-jun Zhang reviewed all capsule
endoscopy studies; and Xiao-lin Li, Su-yu Chen, Hong-bin Chen,
Dong-lin Dai, and Yue Huang performed the majority of the data
analysis. Hong-bin Chen, Su-yu Chen, Hui-wen Song, Dong-lin
Dai, Yuan-yuan Zhao, and Song He edited the manuscript draft.
Small-bowel cleansing for proximal and distal small bowel was
reevaluated by Su-yu Chen and Lin-na Yang.
Reprints: Hong-bin Chen, PhD, MD, Department of Gastroentero-
logy, Sanming First Hospital Affiliated to Fujian Medical
University, Sanming 365000, China (e-mail: smchb2008@qq.com).
Copyright r 2011 by Lippincott Williams & Wilkins
J Clin Gastroenterol  Volume 45, Number 4, April 2011
Key Words: capsule endoscopy, small bowel preparation, mannitol,
simethicone, small bowel cleansing
(J Clin Gastroenterol 2011;45:337–341)
V ideo capsule endoscopy (CE), as a noninvasive imaging
technique, has made a breakthrough in small bowel
exploration. Since it was first introduced in 2000,1,2 this
technology has been mentioned by more than 700 published
studies, which indicates its convenience and widespread
acceptance.3 Although its high diagnostic value is well
known, to date, there is no consensus concerning the
optimal preparation. Previous studies have shown that
diagnostic yield might be limited in approximately 15% to
20% of cases by incomplete small bowel transit because of
the poor battery capacity or prolonged capsule retention,
as well as by reduced visibility because of the intestinal
contents,4,5 particularly in the distal small intestine. There-
fore, it is essential to optimize an enteric preparation
for improving visualization. This prospective, randomized
double-blinded study evaluated the effects of 4 bowel
preparation regimens on small bowel cleansing, diagnostic
yield, and small bowel transit time.
MATERIALS AND METHODS
Patients and Methods
The study protocol conformed to the 1995 Declaration
of Helsinki and was approved by the Ethics Committee
of Sanming First Hospital. All patients provided signed
informed consent for the CE study and for use of the data
and images for research purposes. Between February 2007
and August 2009, a total of 200 consecutive patients who
were referred to the Sanming First Affiliated Hospital of
Fujian Medical University for CE were allocated blindly
in a computer-generated random number sequence to 1 of 4
groups of 50 patients. All this part of the study was carried
on by a gastroenterology assistant who also administered
the study medications. Exclusion criteria included intestinal
obstruction, pregnancy, suspicious impaired intestinal
motility, and history of gastrointestinal surgery.
Patients allocated to group A were instructed to
consume a clear liquid diet after lunch on the day before
CE, followed by an overnight fasting after 22:00 hours. In
group B, 250 mL 20% mannitol and 1 L 0.9% saline were
taken orally at 05:00 hours on the day of the procedure. In
group C, 250 mL 20% mannitol and 1 L 0.9% saline were
taken orally at 20:00 hours on the day before the procedure
and at 05:00 hours on the next day. In group D, in addition
www.jcge.com | 337
Chen et al
to the group C preparation, 20 mL oral simethicone
(Espumisan; Berlin-Chemie, Germany, containing 40 mg
simethicone in 1 mL emulsion) and 200 mL water were
drank 30 minutes before capsule ingestion. Defecation
times at 2 time intervals (the first was the interval from
20:00 hours in the evening before the examination day to
05:00 hours on the examination day, and the second was
the rest period until CE), and adverse events were recorded
by another gastroenterology assistant.
Video CE was performed with the OMOM Capsule
Endoscopy System (Chongqing Jinshan Science and
Technology Group, China)6 according to manufacturer’s
instructions. The novel video CE system consisted of a
smart capsule, image recorder, portable viewer, and image
workstation, with an operating principle similar to that of
the Given Imaging M2A wireless capsule, except that image
capture used a charge-coupled device. All patients in
the 4 groups ingested the capsule at 08:00 hours on the
examination day. After swallowing the capsule, patients
were allowed to drink and eat a light meal at 2 and 4 hours
later. The recorder was disconnected after expiration of the
CE battery, and data were downloaded to a workstation to
be analyzed with its own associated software, Chongqing
Jinshan Image Processing Software, version 4.64.
On the basis of endoscopic findings, a preliminary
diagnosis was given by 5 endoscopists with over 10 years
of professional experience in image reviewing of at least 200
cases. A definite diagnosis was made by 2 senior gastro-
enterologists with imaging-reviewing experience of more
than 300 cases, after reviewing all the submitted thumbnail
images and text reports. Small-bowel cleansing was eval-
uated by 2 experienced investigators. All of them were
unaware of the type of bowel preparation. Any discrepancies
in interpretation of the capsule images were resolved by
consensus before revealing the randomization.
Definitions
Gastric emptying time (GET) was defined as the time
interval from the first gastric image to the first duodenal
image. Small bowel transit time (SBTT) was defined as the
time interval between the entrance into the duodenum and
passage through the ileocecal valve. Both the above were
automatically calculated. SBTT was divided into 2 intervals
of equal duration, with the first half indicating the proximal
small bowel and the second, the distal small bowel, which
were defined by Kantianisa et al.7
Evaluation of Small Bowel Cleansing
First, the whole visibility of the small bowel mucosa
in a single frame of the video was evaluated by image
processing software, Image-Pro Plus version 6.0 (Media
Cybernetics, Inc). After the selected single frame was open
in the window, the area of visible mucosa was outlined,
calculated, and summed, irrespective of brightness or
obstructing elements defined by Brotz et al,8 including
fluid, debris, bubbles, and bile/chyme staining, followed by
the total area of a single frame analyzed in the same way.
Finally, the ratio of the area of unmasked mucosa divided
by the total area of a single frame was scored, using a
modified 4-grade scale based on the criteria of Dai et al9
(3 points if the ratio was 76% to 100% and 2, 1, and 0
points for ratios of 51% to 75%, 26% to 50%, and 0% to
25%, respectively), with a maximum possible score of 3. On
the basis of the score, the view quality of a single frame was
graded as excellent (3 points), good (2 points), fair (1 point),
338 | www.jcge.com
J Clin Gastroenterol  Volume 45, Number 4, April 2011
and poor (0 point). Visibility of every first captured single
frame using the capsule camera at equal intervals of 3
minutes of the playback was estimated. Each independent
score and a total number of observations during proximal
SBTT were recorded for overall assessment, and during
distal SBTT. For overall assessment, small bowel cleansing
for proximal and distal small bowel was separately graded,
and considered adequate if the percentage of the assessed
single frames that was graded as good or excellent was
Z85%, and inadequate if otherwise.
Analysis of Endoscopy Findings
A positive finding was defined as the presence of a
visible mucosal lesion at CE, whether incidental or clinically
relevant, such as a red spot with possible bleeding,10 erosion,
ulcer, blood clot and bleeding, polyp, diverticulum, arter-
iovenous malformation (AVM), varix, venous ectasia, and
ascaris lumbricoides. A red spot is described as a small, flat,
pinpoint, red mark on the gastrointestinal mucosa that is
suspected as a possible site of bleeding. AVM is defined as a
larger red spot, or a confluence of mucosal spots, which also
indicates a possible site of bleeding.11
Statistical Analysis
Differences for categorical variables were assessed using
the w2 test or Fisher exact test (when expected count was <5)
and Pearson w2 test. Differences in constituent proportions
were evaluated using the one-sample goodness-of-fit test.
Differences in means were analyzed using analysis of
variance for normally distributed variables and Kruskal-
Wallis test for non-normally distributed variables. A 2-tailed
P value <0.05 was considered statistically significant. SPSS
version 11.5 was used for statistical analysis. When each
variable was compared with the other 3 (multiple compar-
isons of rate), categorical data between each pairing were
analyzed using the w2 test with Bonferroni correction. The
significance level was, therefore, adjusted to P<0.0083, with
the corresponding w2 threshold of 6.63.
RESULTS
Demographic Data and Indications for CE
A total of 200 consecutive patients referred for CE
owing to suspected small bowel disease were enrolled in
the study. Among them, 127 were outpatients and 73 were
inpatients, with 108 women (54.0%) and 92 men (46.0%).
The overall average age was 52.8±11.4 years (range: 18 to
82 y). The most common indication for CE was obscure
gastrointestinal bleeding (92 of 200, 46.0%), followed
by unexplained abdominal pain (60 of 200, 30.0%), and
chronic diarrhea (48 of 200, 24.0%). Seven (3.5%) patients
were excluded owing to incomplete small bowel transit.
Two patients in group A were excluded owing to prolonged
GET (the capsules remained in the stomach for 92 and
103 min, respectively, and underwent endoscopic place-
ment12) and power switch-off by human error in one case.
One patient in group B was excluded owing to capsule
retention in a diverticulum. Two patients in group C were
excluded owing to delayed gastric emptying (the capsule
stayed in the stomach for 88 min) and ileal perforation
caused by ileal adenocarcinoma. One patient in group D
was excluded because the capsule was trapped in an
intestinal stricture complicated by ileal Crohn’s disease.
Finally, 193 patients were involved in the analysis. There
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J Clin Gastroenterol  Volume 45, Number 4, April 2011 Small Bowel Preparations for Capsule Endoscopy

TABLE 1. Clinical Data of 193 Patients Undergoing Capsule Endoscopy

Patient Characteristics A (n=47) (%) B (n=49) (%) C (n=48) (%) D (n=49) (%) P
Males (n=89) 22 (46.8) 21 (42.9) 24 (50.0) 22 (44.9) w2 =0.539 0.910
Females (n=104) 25 (53.2) 28 (57.1) 24 (50.0) 27 (55.1)
Aged (y; 51.6±12.3 SD) 53.6±11.6 50.6±11.5 50.9±12.2 52.0±12.6 F=0.593 0.621
Inpatients (n=70) 16 (34.0) 17 (34.7) 19 (39.6) 18 (36.7) w2 =0.386 0.943
Outpatients (n=123) 31 (66.0) 32 (65.3) 29 (60.4) 31 (63.3)
Obscure gastrointestinal bleeding (n=91) 23 (48.9) 23 (46.9) 22 (45.8) 23 (46.9) w2 =0.237 0.983
Unexplained abdominal pain (n=57) 13 (27.7) 15 (30.6) 14 (29.2) 15 (30.6)
Chronic diarrhea (n=45) 11 (23.4) 11 (22.4) 12 (25.0) 11 (22.4)

was no significant difference in sex, age, case source, or
indication among the 4 groups (P>0.05) (Table 1).
GET and SBTT
GET was 48.32±9.98 minutes in group A,
47.61±11.12 minutes in group B, 49.56±11.51 minutes in
group C, and 46.96±12.78 minutes in group D, which did
not differ significantly between the groups (F=0.461,
P=0.710). Similarly, SBTT did not differ significantly
between the groups: 301.62±73.38 minutes in group A,
299.02±76.32 minutes in group B, 286.63±68.83 minutes in
group C, and 283.88±84.85 minutes in group D (F=0.649,
P=0.585). In addition, during the first time interval from
20:00 hours in the evening before the examination day to
05:00 hours on the examination day, several episodes of
defecation were recorded in groups C and D, whereas no
defecation occurred in groups A and B. In the second time
interval from 05:00 to 8:00 hours on the day of CE, all
patients in each group defecated for a varying number of
times (Table 2).
Positive Rate Analysis
A definite or probable diagnosis was achieved in 193
patients. The red spot (48 of 156, 30.8%) was the most
common mucosal lesion, followed by mucosal erosion (32
of 156, 20.5%), AVM (21 of 156, 13.5%), ulcer (17 of 156,
10.9%), polyp (9 of 156, 5.8%), venous ectasia (7 of 156,
4.5%), diverticulum (6 of 156, 3.8%), intestinal varix (5
of 156, 3.2%), and ascaris lumbricoides (4 of 156, 2.6%).
Seven patients (4.5%) with recent or ongoing intestinal
bleeding did not show any obvious lesion by CE (Table 4).
Eighty-two pathological lesions were found in the
proximal small bowel, of which the constituent proportions
in groups A, B, C, and D were 18.29% (15 of 82), 15.85%
(13 of 82), 19.51% (16 of 82), and 46.34% (38 of 82),
respectively. The proportion in group D was significantly
larger than in the 3 other groups (w2=20.146, P=0.000).
Seventy-four pathological lesions were detected in the distal
small bowel: group A, 14.86% (11 of 74); group B, 13.5%
(11 of 74); group C, 33.78% (25 of 74); and group D, 37.84%
(28 of 74). Groups C and D showed higher proportions
(w2=13.053, P=0.005) (Table 5).

Patient Tolerance and Adverse Events

Assessment of Small Bowel Cleansing
In overall adequacy assessment (OAA) of proximal
small bowel, there were significant differences between the
groups A and D (w2=9.219, P=0.002), B and D (w2=7.470,
P=0.006), and C and D (w2=8.908, P=0.003), but no
differences between the groups A and B (w2=0.126,
P=0.723), A and C (w2=0.004, P=0.947), and B and C
(w2=0.084, P=0.772). The OAA in group D showed the best
overall proximal small bowel cleansing.
In OAA of distal small bowel, there were significant
differences between the groups A and C (w2=11.628,
P=0.001) and A and D (w2=12.036, P=0.001), but no
differences between the groups A and B (w2=2.010,
P=0.156), B and C (w2=4.377, P=0.036), B and D (w2=
0.462, P=0.032), and C and D (w2=0.002, P=0.967). Bowel
preparation with administration of oral mannitol twice for
CE improved overall cleansing of the distal small bowel when
compared with 10-hour overnight fasting (Table 3).
Compliance with each preparation was 100%, and all
patients completed the procedure without serious adverse
effects. Paroxysmal abdominal pain occurred in only 2
patients with chronic constipation after mannitol adminis-
tration, and disappeared rapidly. All patients swallowed the
smart capsule easily.
DISCUSSION
To the best of our knowledge, this present study is the
first and the largest prospective, randomized double-
blinded study to analyze mannitol followed by simethicone
as a preparation regimen for CE.
CE provides a convenient option for examining the
mucosa of the small bowel, with higher visibility leading to
more findings. However, the image quality of CE is influenced
by 4 major factors: the performance of the CE system affects
brightness, mucosal stretch, air bubbles, and opaque intra-
luminal contents, a general term that encompasses bile, mucus,

TABLE 2. Comparison of the Conditions in 4 Groups: Gastric Emptying Time, Small Bowel Transit Time, Defecation Times (Mean±SD)

Gastric Emptying Time Small Bowel Transit Defecation Times

Group n Mean±SD (min) Time Mean±SD (min) First Time Interval Second Time Interval
A 47 48.32±9.98 301.62±73.38 — 1.3±0.8
B 49 47.61±11.12 299.02±76.32 — 8.7±5.2
C 48 9.56±11.51 286.63±68.83 7.8±5.6 6.3±4.6
D 49 6.96±12.78 283.88±84.85 7.6±5.4 6.4±4.3
F =0.461, P=0.710 F =0.649, P=0.585

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Chen et al
TABLE 3. Comparison of Small Bowel Cleansing in 4 Groups (Case)
Proximal Small Bowel
Group n Adequate (%) Inadequate (%)
A 47 34 (72.3) 13
B 49 35 (71.4) 14
C 48 34 (70.8) 14
D 49 45 (91.8) 4 (8.2)
food residue, and even fecal residue.13,14 Among current CE
systems that are manufactured by 4 companies, the OMOM
small bowel capsule was chosen for this study, which was
13 27.9 mm in size, and contained a lens system with a 140
degrees angle of view, a charge-coupled device video chip, and
a recording duration of 7 to 9 hours. Since 2005, more than
50,000 OMOM capsules have been consumed around the
world, which indicates widespread acceptance.
With regard to the latter 3 impact factors, they might be
modulated by different bowel preparations. The preparation
that is suggested by the manufacturers of the Given Imaging
Ltd CE system consists only of a clear liquid diet and an
8-hour overnight fast.15–17 However, there is sufficient
evidence to suggest a benefit from medical preparations for
CE.6 Our study also demonstrated that defecation times in
all bowel medication groups were more than those in the
nonmedication group, which implies the presence of fecal
residue in the small and large bowel. To date, there is no
consensus on the optimal preparation regimen, and some
trials have even obtained contrasting results. In terms of CE
completion rate or GET and SBTT, bowel medical prepara-
tions seem to make no difference. For instance, Kalantzis
et al15 have found that neither sodium phosphate nor
polyethylene glycol alters GET, SBTT, or the probability of
cecum visualization, compared with a liquid diet before CE,
nor did mannitol plus simethicone used in our study.
Many options for preparation before CE that in-
volve clear liquids, electrolyte solution, polyethylene glycol,
sodium phosphate, mannitol, magnesium sulfate, prokinetics,
and simethicone have been derived mostly from methods used
with colonoscopy.18–21 Among these, polyethylene-glycol-
based electrolyte solution (PEG4000) has been used most
often, which has been stated in the European Society of
Gastrointestinal Endoscopy Guidelines.7 However, when cost
effectiveness is taken into consideration, PEG offers no
superiority to other drugs. As a result, mannitol was selected
in our study. By oral administration, mannitol can act as an
osmotic laxative. A preparation of 250 mL 20% mannitol
followed by 1 L 0.9% saline was able to soften stools, stimulate
gastrointestinal peristalsis, accelerate fecal excretion, wash out
intraluminal contents, and avoid excessive stimulation and
dehydration of the intestinal wall. Although there were 2
patients who complained of abdominal pain after taking
mannitol, their discomfort disappeared spontaneously without
any symptomatic treatment.
TABLE 4. Different Pathological Lesion (%)
Red
Pathological Spots Erosions AVMs Ulcers Varices
Percentage 48 (30.8) 32 (20.5) 21 (13.5) 17 (10.9) 5 (3.2)
AVM indicates arteriovenous malformation.
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J Clin Gastroenterol  Volume 45, Number 4, April 2011
Distal Small Bowel
Adequate (%) Inadequate (%)
(27.7) 24 (51.1) 23 (48.9)
(28.6) 32 (65.3) 17 (34)
(29.2) 40 (83.3) 8 (16.7)
41 (83.7) 8 (16.3)
Simethicone is an inert substance with antifoaming
activity. It can reduce gastrointestinal gas and sensitization
of primary afferent nerve endings. Therefore, it can be used
for relieving fullness in patients with functional dyspepsia22
and abdominal pain in patients with irritable bowel
syndrome.23 As a result of these features, we added 20 mL
simethicone after mannitol in group D. First, this reduced
air bubbles, which was confirmed by comparing overall
cleansing of the proximal small bowel between the groups C
and D, and second, it decreased production of flammable
gas (namely, hydrogen)24 and abdominal discomfort caused
by mannitol administration. The same result has also been
obtained by Fang et al13 who reported that oral simethi-
cone could significantly lower the proportion of small
bowel mucosa masked by air bubbles in the image frame.
The lack of standardized scales for accurate quantifi-
cation of small bowel cleansing in all published studies
makes evaluation of results problematic and unreliable,
let alone comparison of results between different studies. To
achieve a relatively objective evaluation of bowel prepara-
tion, we created a new assessment for the proportion of
small bowel mucosa visible in a single frame, which led to a
corresponding score rating. In our opinion, this software-
based assessment can avoid the problems that come from
human visual assessment. For OAA of proximal and
distal small bowel, we followed the method designed
by Kantianisa et al.7 The 2-step system created in our
study ensures the individuality and integrity of the analysis.
For administration dosage and times, regardless of
which preparation, the results of large bowel cleansing and
patient acceptance have been conflicting. Curran and
Plosker25 have found that 90 mL sodium phosphate admi-
nistered twice orally is more effective for colorectal cleansing
than when it is administered only once. A new meta-
analysis26 of 4 randomized controlled trials has concluded
that the use of split-dose PEG for bowel preparation before
colonoscopy significantly improves quality of bowel pre-
paration, decreases nausea, and increases patient compliance
compared with full-dose PEG, even when both are
administered at the same dose. Similarly, if bowel prepara-
tion is divided into several doses before CE, it might achieve
the same results. However, 2 trials conducted by Kantianisa
et al7 and Park et al27 have concluded that bowel preparation
with 2 or 4 L PEG resulted in no difference in image quality,
GET, SBTT, cecal completion rate, and lesion detection rate.
Blood
Venous Clots or Ascaris
Ectasias Polyps Diverticulum Bleeding Lumbricoides
7 (4.5) 9 (5.8) 6 (3.8) 7 (4.5) 4 (2.6)
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J Clin Gastroenterol  Volume 45, Number 4, April 2011
TABLE 5. Lesions of Proximal Small Bowel and Distal Small Bowel
Lesions (156) Group A (n=47) (%) Group B (n=49) (%)
Proximal small bowel (82) 18.29 (15/82) 15.85 (13/82)
Distal small bowel (74) 14.86 (11/74) 13.5. (10/74)
In consideration of patients’ inconvenience, 2 L PEG might
be an appropriate method of bowel preparation for CE. In
our study, 2 regimens with mannitol (single dose in group B,
and split dose and double dose in groups C and D,
respectively) were equivalent with regard to GET, SBTT,
and proximal small bowel cleansing, but cleansing of the
distal small bowel in group D was better than that in group B
(which might be the difference with or without simethicone).
The total dose of mannitol in groups C and D was twice that
in group B. A fractioned intake, as recommended by Rey
et al28 was adopted to minimize patient discomfort.
In conclusion, a preparation regimen for CE, which
involves administration of oral mannitol twice followed
by single administration of simethicone, can improve visual
quality in the proximal and distal small bowel when
compared with 10-hours overnight fasting, thereby increas-
ing the diagnostic yield accordingly.
ACKNOWLEDGMENTS
The authors thank Dr Cao-Dong Wang and Dr Chun-
kang Yang for their editorial assistance. They also thank
their colleagues, technicians, and nurses for their great help
and cooperation during performing this study.
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