Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy.
OBJECTIVE
Polyethylene glycol (PEG)-based gut lavage solutions are safe and effective, but require consumption of large volumes of fluid. We compared a new 2 L solution of PEG plus ascorbic acid (PEG + Asc) with standard 4 L PEG with electrolytes (PEG + E) for bowel cleansing before colonoscopy to determine efficacy, safety, and patient acceptability.


METHODS
Consenting adult inpatients scheduled to undergo colonoscopy were randomized to receive either 2 L PEG + Asc or 4 L PEG + E. Preparations were taken as split doses the evening before colonoscopy and the following morning. The PEG + Asc group took 1 L at each administration (i.e., total dose of 2 L). The PEG + E group took 2 L at each administration (i.e., total dose of 4 L). Bowel cleansing success was assessed via videotapes by independent, blinded raters. Statistical noninferiority was predefined as a difference of <15% in the lower limit of the 97.5% confidence interval for treatment difference. Patient views on the preparations were elicited. Adverse events were noted.


RESULTS
Successful gut cleansing was achieved in 136 of 153 (88.9%) cases of the PEG + Asc group and 147 of 155 (94.8%) cases of the 4 L PEG + E group (mean difference -5.9 [-12.0-infinity]). The difference fell within the predefined limit for noninferiority. Clinical and laboratory parameters showed no difference in safety profile. Patient ratings of acceptability and taste were better for the PEG + Asc group than for the PEG + E group (P < 0.025).


CONCLUSIONS
The combination of ascorbic acid and PEG-based bowel preparation reduces the volume patients have to drink without compromising efficacy or safety. The low-volume PEG + Asc preparation was more acceptable to patients, and should, therefore, improve effectiveness in routine practice.
Ell
Christian
C
Dr. Horst Schmidt Kliniken GmbH, Wiesbaden, Germany.
Fischbach
Wolfgang
W
Bronisch
Hans-Joachim
HJ
Dertinger
Stefan
S
Layer
Peter
P
Rünzi
Michael
M
Schneider
Thomas
T
Kachel
Günther
G
Grüger
Jörg
J
Köllinger
Michael
M
Nagell
Waltraud
W
Goerg
Karl-Josel
KJ
Wanitschke
Roland
R
Gruss
Hans-Jürgen
HJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001205:Ascorbic Acid / Q000008:administration & dosage*; D002400:Cathartics / Q000008:administration & dosage*; D003113:Colonoscopy; D004573:Electrolytes / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012996:Solutions; D007507:Therapeutic Irrigation
D002400:Cathartics; D004573:Electrolytes; D012996:Solutions; D011092:Polyethylene Glycols; D001205:Ascorbic Acid