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Ital J Gastroenterol l993; 25:174-178 ORIGINAL ARTICLES A randomized controlled trial of a new PEG-electrolyte solution
compared with a standard preparation for colonoscopy
OA PAOLUZI, MARIA CARLA DI PAOLO, F RICCI, C PASQUALI, S ZARUG, F DE LIBERO, P PAOLUZI
Cattedra di Gastroenterologia, Istituto di Il Clinica Medica, Università "La Sapienza", Roma, Italy
The efficacy, tolerability and patient acceptance of a
vage with a nonabsorbable oral solution (1,2) was intro- new flavoured PEG solution for gut lavage was com-
duced as an alternative to standard colonic preparation pared with a standard preparation for bowel cleans-
(low-residual diet, laxatives and cleansing enemas). Ini- ing in a randomized controlled trial of patients under-
tially, the diffusion of the new method was limited by going colonoscopy. One hundred and sixty patients
the presence of side-effects caused by the hyperos- were randomly allocated either to a standard
molarity of the oral solutions (3). Iso-osmotic oral solu- preparation (2-day semi-liquid diet, laxatives and
tions for whole gut lavage have been available since cleansing enemas) or to gut lavage (fractionized inges-
1980 (4) and their use has greatly reduced the side-ef- tion of lavage solution two litres in the afternoon
fects. Although gut lavage with iso-osmotic oral solu- before and a third litre the morning of the examina-
tions proved to be effective and better tolerated (5,6), tion). Adequacy of colon cleansing was scored evaluat-
patient acceptance of this method of intestinal prepara- ing residual stool in each colonic segment and overall
tion to colonoscopy remained poor due to the un- mucosal visibility. Tolerability of methods was as-
pleasant (salty) taste and onset of nausea and abdominal sessed by evaluating the incidence and severity of side-
fullness (7-9). A new iso-osmotic oral solution* for gut effects. Patient acceptance was graded (good, fair to
lavage has recently been shown to be effective and good, poor) according to the patient's judgement
well-tolerated in a multicentric open trial (10).
about the ease of execution and interference with sleep
A randomized controlled trial was undertaken in or- and working activity. Less residual stool (p<0.05) and
der to evaluate the efficacy, tolerability and patient ac- better visualization of colonic mucosa (p<0.05) were
ceptance of this new gut lavage solution compared to obtained with gut lavage than with standard prepara-
the standard preparation.
tion. Both methods were well-tolerated and a low in-
cidence of side effects was recorded in both groups.
Patient acceptance was good in more than 80% of pa-
Patients and methods
tients in both groups. We conclude that gut lavage is a
One hundred and sixty patients requiring colonos- rapid, effective and well-tolerated method for bowel
copy were admitted to the study. Presence of stenosis, cleansing. The use of a flavoured solution in a frac-
suspected perforation of the gut, colonic resection tionized schedule seems to improve the tolerability
and pregnancy were considered to be excluding crite- and the patient acceptance of this method.
ria. Patients were randomized to either gut lavage or Index terms: Colonoscopy, Gut lavage, PEG-electrolyte
solution, Standard preparation.
Gut lavage The solution tested, prepared at moment Address for correspondence: Prof. P Paoluzi, Cattedra di of assumption, was composed as follows: 14.75 mEq Gastroenterologia, Il Clinica Medica, Policlinico Umber- polyethylene glycol 4000, 125 mEq sodium, 80 mEq to I, Viale del Policlinico 157 00161, Roma, Italy sulfate, 20 mEq bicarbonate, 10 mEq potassium and35 mEq chloride per litre, plus sweeteners and Accepted for publication: 19 April 1993 flavourings. The final osmolarity of the solution re-sulted 280-290 mOsm.
Patients were instructed to drink 250 ml of the The increasing diagnostic demand for endoscopic solution every 15 minutes. The total amount of solu- exploration of the entire colon justifies the continuous tion prescribed was 3 litres: 2 litres were drunk in the search for a simple, rapid and effective method ofbowel cleansing. In the middle of the ‘seventies, a newmethod for bowel cleansing consisting of whole-gut la- *ISOCOLAN® (Giuliani S.p.A. - Bracco S.p.A., Milano, Italy) OA PAOLUZI et al: Gut lavage vs standard preparation for colonoscopy Table I. Indications to colonoscopy in the two groups of
cal residues for each colonic segment and the overall mucosal visibility. The presence of residues was sco- Gut lavage
Standard preparation red as follows: 0 = no residue or minimal clear fluid; 1= small amount of liquid stool; 2 = moderate amount of liquid stool; 3 = large amount of liquid stool or so- lid stool. The overall mucosal visibility was graded as follows: excellent when the mucosa was clearly visi- ble in the whole colon; adequate when most of the mucosa was visible; poor when the visibility of a largeportion of the mucosa was reduced; inadequate whenmost of the mucosa was not visible.
Table II. Reasons why colonoscopy was partial in the two
groups of patients.
Evaluation of tolerability and patient acceptance Befo- Standard preparation re the colonoscopy, each patient was interviewed by a physician about the tolerability of the preparation. The questions concerned the onset of side-effects during the preparation and the need to interrupt the preparation due to side-effects. The patient was asked to judge ac-ceptance of preparation (ease of execution, interferencewith sleep and working activity) which was evaluated afternoon before (6-8 p.m.) and the third litre the as follows: good = completely positive; fair to good = morning of examination (6-7 a.m.). All patients fol- moderately positive; poor = completely negative.
lowed a free diet until two hours before the ingestionof the oral solution: afterwards, patients were advised Statistical analysis of data The data were analyzed to fast or to ingest only liquid foods (tea, coffee, juice, using the Chi-square test. P values less than 0.05 we- soup). Cleansing enemas or assumption of laxatives re considered to be statistically significant.
were not allowed during the preparation period.
Standard preparation This consisted of a strict low- One hundred and sixty patients entered the study residual semi-liquid diet (avoidance of fruit, vegeta- and were randomized to the two preparation groups.
bles, bread, meat and other solid foods) during the two Twenty-four patients (15 in the gut lavage and 9 in the days preceding colonoscopy, and the assumption of 35 standard preparation group) failed to present the day of g of castor oil in the afternoon (4 p.m.) before examination and 4 patients in the gut lavage group li- colonoscopy. A cleansing enema of two litres of tap mited the ingestion of solution because of onset of si- water was prescribed for the evening before and the de-effects. The results concerning the adequacy of morning of the examination. The patients fasted from preparation, therefore, refer to 132 patients, 71 (43 ma- the eve of the examination.
le and 28 female; average age: 48.7±18.7, range: 15-84yrs) taking the standard preparation, and 61 (36 male Evaluation of colonic cleansing Colonoscopy was and 25 female; average age: 53.3±15.7, range: 17-82 performed by a physician blind to the preparation used yrs) taking the gut lavage. The indications for colonos- by the patient. The accuracy of colon cleansing was copy in the two groups are shown in Table I.
determined by evaluating the type and amount of fae- A total colonoscopy (reaching the proximal colon) Table III. Presence of residual stool by colonic segment in the two groups of patients.
Standard preparation 0 = no residue or minimal clear fluid; l = small amount of liquid stool; 2 = moderate amount of liquid stool; 3 = large amount of li-quid or solid stool. P values refer to the comparison of grades 2 and 3 incidence in the two groups for each colonic segment OA PAOLUZI et al: Gut lavage vs standard preparation fur colonoscopy Fig. 1. Percentages of patients with scores 2 and 3 of residual
Fig. 2. Percentages of patients with different grades of overall
stool by colonic segment in the gut lavage and standard pre- visibility of colonic mucosa in the gut lavage and standard paration groups. preparation groups (excellent+adequate visibility: 84% vs 63%; x2= 5.78; p< 0.05). Table IV. Overall mucosal visibility of the colon in the two
groups of patients.
standard preparation group (Table V). Nausea, ab- Standard preparation dominal fullness and abdominal cramps were more fre-quently experienced during the gut lavage, whereas ab- dominal cramps and anal distress were more frequent during the standard preparation. These symptoms were mild in intensity and brief in duration, they disappeared spontaneously with no need for any treatment, and allthe patients reporting side-effects, except four in the gutlavage group, were able to complete the preparation. Intwo of them ingestion of the solution was stopped due was performed in 109 out of 132 patients (82.5%), 58 to the onset of severe nausea and/or abdominal fullness in the standard preparation group and 51 in the gut la- after 2 litres and in the other two after 1 litre. Although vage group. The reasons why the exploration of the their intestinal preparation was incomplete, these four colon was limited are shown in Table II. Data regard- patients were submitted to endoscopy. Total colonos- ing the presence of fecal residues in each colonic seg- copy was performed in the two patients who drank two ment of patients in the two groups are shown in Table litres of solution, whereas colonoscopy was limited to III. The gut lavage group showed a statistically sig- the sigmoid segment in the other two patients because nificant lower presence of moderate or abundant resi- of lack of adequate cleansing of the colon.
dual stools in the cecum/ascending colon (15.5% vs Data regarding patient acceptance of the methods 45%; p<0.0l), in the transverse colon (18% vs 38%; of intestinal preparation are shown in Table VI. The p<0.05) and in the descending colon (15% vs 32%;p<0.05) than the standard group, whereas in the rec- Table V. Side-effects experienced by the patients during the
tosigmoid only a trend was observed (18% vs 21%; two methods of intestinal preparation. n.s.) (Fig. 1).
Gut lavage (65 pts) Standard preparation (71 pts) Data regarding the overall visibility of the colonic mucosa in the two groups are shown in Table IV. Ex-cellent or adequate visibility was reported in 51 out of the 61 (84%) patients in the gut lavage group com- pared with 45 out of the 71 (63%) patients in the stan- dard preparation group, a difference which is statisti- cally significant (p<0.05) (Fig. 2).
Both methods of intestinal preparation were well- tolerated in the majority of patients. Side-effects were present in 8 patients out of 65 (12.3%) in the gut lava- ge group and in 11 patients out of 71 (15.5%) in the OA PAOLUZI et al: Gut lavage vs standard preparation for colonoscopy Table VI. Patients with different grades of acceptance to gut
In the present study, the gut lavage appeared more lavage and standard preparation for bowel cleansing. effective than the standard preparation in bowel Standard preparation cleansing, with a better visualization of the mucosa in all the colonic segments except the rectosigmoid where both methods were equally effective. It should be noted that, in two patients who only ingested two litres of the lavage solution, the intestinal preparation was adequate to allow a total colonoscopy with goodmucosal visibility as far as the cecum. This suggeststhat in some cases the ingestion of 2 litres of lavage Table VII. Side-effects (%) reported in different studies on
solution would be sufficient to obtain adequate bowel gut lavage. cleansing, which is in accordance with the data of Vi- Fullness Cramping Nausea Vomiting lien et al (17).
Tolerability and patient acceptance are two impor- tant requirements of methods employed for intestinal van der Heide (23) preparation, especially in patients requiring periodical endoscopic controls (history of polyps, inflammatory bowel disease). The use of iso-osmotic oral solutionshas abolished systemic side-effects (4), b u tgastrointestinal symptoms (nausea, vomiting and ab- judgement on acceptance of preparation from patients dominal tenderness) and interference with working who presented side-effects was excluded as conside- activity and with sleep (9) are still major side-effects red biased. A high percentage of patients in both the of the gut lavage method. The reasons for the onset of gut lavage and in the standard preparation groups these side-effects are the large volume of liquid to be (89.5% and 81.6%, respectively) declared that accep- ingested (three-four litres) and the unpleasant taste of tance of the method performed was good. Acceptance the solutions employed in the gut lavage (8,9). Diffe- was completely negative in 4 patients submitted to rent ways to reduce the side-effects during the gut la- gut lavage because of interference with sleep and in 6 vage have been suggested. In some studies the ef- submitted to the standard preparation because the ficacy of anti-emetic and prokinetic drugs such as length and complexity of the preparation limited metoclopramide (13,14,18) or cisapride (19) has been working activity.
evaluated during the gut lavage with non-conclusiveresults. Recently, new iso-osmotic oral solutions with low sodium (20) or sulfate concentration (8,9), or en-riched with flavourings and sweeteners (21,22) were Adequate colon cleansing is essential for a rapid, sa- proposed. However, the results concerning the im- fe and effective endoscopical examination. The stan- provement of the taste of these new oral solutions dard preparation (diet, laxatives and enemas) is generally satisfactory (11,12) but patients complain In our study the gut lavage method with a flavou- about the duration of diet (at least two days) and the red solution was well-tolerated and the incidence of discomfort provoked by the use of laxative and ene- side-effects was lower than in other studies (Table mas; furthermore this preparation is time consuming VII). Our results may have been influenced by the in- (13,14). Since the introduction of the iso-osmotic oral gestion schedule of the oral solution followed by the solution (4), the gut lavage method has represented a patients: 2 litres the afternoon before and 1 litre the valid alternative to the standard preparation and has morning of colonoscopy. This fractionized assump- been widely employed. Several studies (5,6,12,13,15) tion may determine less abdominal distension than have demonstrated that gut lavage provides better the single time ingestion and therefore better toleran- cleansing of the colon than the standard preparation.
ce by the patients, as already suggested by Rey et al Pockros and Foroozan (16) also observed that there is (21). Another reason may be the new formulation no histological damage of the colonic mucosa after the adopted in our study, enriched with flavourings and gut lavage with polyethylene glycol solution, whereas sweeteners. The greater palatability of the solution the preparation with laxatives causes flattening of the seems to improve the compliance to its ingestion, as surface of epithelial cells and depletion of goblet cells.
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