Gastroenterology
 
Clinical Results

 


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.

- 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:
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.
Group 2: 2F Group - CLD/Phospho-soda
Diet:
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.

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.

   
Excellent
  Negligible amount of liquid stool with a little amount of suction required.
   
   
Good
  Moderate amount of liquid stool, but easily removed by suction.
   
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.


A Prospective Study to Assess the Efficacy and Patient Satisfaction of Three Bowel Preparations for Colonoscopy.

- 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:
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.
Group 2: NutraPrep/LoSo Prep
Diet:
Prepackaged, low-residue solid and liquid foods.
Laxation: Same as Group 1.
Group 3: NutraPrep/PEG
Diet:
Prepackaged, low-residue solid and liquid foods.
Laxation: Polyethylene Glycol Electrolyte Solution (one gallon) starting at 6:00 p.m. the day before colonoscopy.

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


  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

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.


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.
- 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:
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).
Group 2: Clear Liquid Diet/Phospho-soda
Diet:
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.

Results
Table 2. Quality of Preparation

  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

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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