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Gastroenterology |
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Clinical Results |
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DeLegge, et. al., Medical University of South Carolina
Purpose
Compare patient compliance and colon preparation using NutraPrep and
LoSo Prep compared to a clear liquid diet (CLD) and Phospho-soda
regimen to determine whether a meal could be consumed during standard
bowel preparation.
Method
After obtaining informed consent, 506 patients were prospectively randomized
into one of two groups. |
| Group 1: |
NP-LS Group - NutraPrep/LoSo
Prep
Diet:
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Prepackaged,
low-residue solid and liquid foods. |
| Laxation: |
Mg
citrate (1 powdered sachet) given at 4:00 p.m. the
day prior to the colonoscopy, followed by three 8-oz
glasses of water. (4) 5 mg oral bisacodyl tablets
were taken 2 hours after ingestion of mg citrate
preparation. 10 mg bisacodyl suppository administered
on the morning of the scheduled procedure. |
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| Group 2: |
2F Group
- CLD/Phospho-soda
Diet:
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Clear liquids on
the day prior to colonoscopy. |
| Laxation: |
(2) 45 mL doses of
Fleet Phospho-soda ingested the day prior to the
procedure with the first dose taken in the late afternoon
followed by 8 oz of water. This was repeated 4 hours
later. |
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Results
NutraPrep combined with LoSo Prep achieved
superior colon cleansing compared to the CLD regimen. In
addition, NutraPrep with LoSo Prep received superior patient
compliance and tolerance ratings than the standard regimen.
Patients in the NP-LS group were also more likely to repeat
their same colon preparation versus the 2F group.
Colon preparation was rated Excellent or Good in 89% of the
NP-LS group versus 82% in the 2F group. |
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Excellent |
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Negligible amount of liquid stool with a little amount
of suction required. |
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Good |
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Moderate amount of liquid stool, but
easily removed by suction. |
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Reference:
DeLegge M, Kaplan R. Efficacy of bowel preparation with the use of a prepackaged,
low fibre diet with a low sodium, magnesium citrate cathartic vs. a clear
liquid diet with a standard sodium phosphate cathartic. Aliment Pharmacol
Ther 2005; 21:1491-1495. |
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Rapier, et al., Southern California Kaiser Permanente Medical
Group
Purpose
To evaluate the adequacy of bowel cleansing and patient acceptance
of Polyethylene Glycol Electrolyte Solution (PEG) or a Magnesium
Citrate bowel preparation kit (LoSo Prep) with a nutritional food
kit (NutraPrep) versus LoSo Prep and clear liquid diet prior to colonoscopy.
Method
After obtaining informed consent, 114 patients were randomly assigned
to one of three study preparations: |
| Group 1: |
Clear Liquid Diet/LoSo Prep
Diet:
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Clear liquids on
the day prior to colonoscopy. |
| Laxation: |
Mg citrate (one powdered
sachet) given at 5:30 p.m. the day before the procedure.
(4) 5 mg oral bisacodyl tablets at 7:30 p.m. on the
day before the procedure. 10 mg bisacodyl suppository
administered on the day of procedure at least 1 hour
prior to departure. |
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| Group 2: |
NutraPrep/LoSo Prep
Diet:
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Prepackaged, low-residue
solid and liquid foods. |
| Laxation: |
Same as Group 1. |
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| Group 3: |
NutraPrep/PEG
Diet:
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Prepackaged, low-residue
solid and liquid foods. |
| Laxation: |
Polyethylene Glycol
Electrolyte Solution (one gallon) starting at 6:00
p.m. the day before colonoscopy. |
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| The adequacy of bowel preparation
was graded by the one Endoscopist (RCR) performing all the procedures.
The preparations were rated by patients for tolerance, compliance,
side effects and desire for food.
Results
Table 2. Quality of Preparation |
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Group 1 |
Group 2 |
Group 3 |
Group 4 |
| Preparation Rated Excellent |
18 (49%) |
24 (63%) |
22 (56%) |
< 0.0018 |
| Adequate Visualization of the Colon |
35 (95%) |
38 (100%) |
39 (100%) |
0.0860 |
| Moderate to Large Amount of Retained
Stool |
7 (19%) |
4 (11%) |
3 (8%) |
0.0597 |
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| Patients in Group 2 (NutraPrep/LoSo Prep) had
a cleaner colon as compared to Groups 1 and 3, p=0.0018.
Group 1 patients retained more moderate to large amounts of stool (p=0.0597),
and adequate visualization was decreased (p=0.0860) as
compared to Groups 2 and 3; however, the results were not statistically
significant.
Cleansing: LoSo Prep and NutraPrep
was statistically better in colon cleansing as compared
to PEG and NutraPrep, and LoSo Prep and a clear liquid diet.
Compliance: No statistical difference was seen between
clear liquid diet and NutraPrep.
Tolerability: With or without NutraPrep, LoSo
Prep was more tolerable statistically than PEG. |
Reference:
Rapier R, Houston C. A prospective study to assess
the efficacy and patient satisfaction of three bowel preparations
for colonoscopy. Gastrointestinal Endoscopy 2004; 59(5):AB131. |
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| - El-Baba, et
al., Childrens Hospital of Michigan, Wayne State University
Purpose
To evaluate the adequacy and acceptance of the bowel cleansing prep
and nutritional food package for colonoscopies in children. The prepackaged,
low-residue liquid and solid foods in combination with magnesium
citrate, bisacodyl tablets and suppository (E-Z-EM), was compared
with oral sodium phosphate (Fleet® Phospho-soda).
Methods
After obtaining informed consent, 65 patients were randomly assigned
to one of two study preparations: |
| Group 1: |
NutraPrep/LoSo Prep
Diet:
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Prepackaged, low-residue
solid and liquid foods (E-Z-EM NutraPrep) on the day
prior to procedure. |
| Laxation: |
Mg citrate (one powdered
sachet) given at 6:00 p.m. the day before the procedure.
Oral bisacodyl tablets at 8:00 p.m. on the day before
the procedure (dose: >12 yr: 20 mg; 8-12 yr: 15
mg; 4-8 yr: 10 mg). Bisacodyl suppository administered
on the day of procedure at least 1 hour prior to departure
(dose: >12 yr: 10 mg; <12 yr: 5 mg). |
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| Group 2: |
Clear Liquid Diet/Phospho-soda
Diet:
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Clear liquids on the
day prior to colonoscopy. |
| Laxation: |
45 mL/1.7 m2 of
Fleet Phospho-Soda mixed with equal amount of water
given at 3:00 p.m. the day before the procedure, repeated
at 6:00 p.m., followed by continual hydration with
clear liquids 1.5-2.0 L/1.7 m2 until retiring
for the evening. |
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Results
Table 2. Quality of Preparation |
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Group 1 |
Group 2 |
p-Valve |
| Preparation Rated Excellent |
18 (50%) |
5 (17%) |
< 0.017 |
| Adequate Visualization of the Colon |
33 (92%) |
24 (83%) |
0.44 |
| Moderate to Large Amount of Retained
Stool |
9 (25%) |
17 (59%) |
< 0.02 |
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| E-Z-EM bowel cleansing preparation and nutritional
food package resulted in a superior colon cleansing and decreased amount
of retained stool as compared to oral sodium phosphate and clear
liquid diet.
Patients who took oral sodium phosphate
and clear liquid diet were much more likely to experience
hunger and desire for food during the preparation compared
to those who took the E-Z-EM bowel cleansing preparation
and nutritional food package.
Both regimens did not significantly differ in adequacy of
colon visualization, preparation tolerance, side effects or
compliance.
E-Z-EM bowel cleansing preparation and
nutritional food package has been demonstrated to be an effective,
safe and well-tolerated bowel regimen. |
Reference:
El-Baba MF, Houston C, Padilla M, Madani S, Lin
C-H, Thomas R, Tolia V. A prospective study to assess the efficacy
of bowel preparation in pediatric patients with the use of a bowel
cleansing preparation and a nutritional food package compared with
oral sodium phosphate. Journal of Pediatric Gastroenterology
and Nutrition 2003; 37:329. |
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| To learn more about NutraPrep or
LoSo Prep, click on the appropriate image below. |
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