THERAPEUTIC NEWS
Acceptability of the colonic preparation.
The interest in fractioning Fortrans® doses
for a better preparation to colonoscopy
J.F. REY* & J.C. SOUQUET**
(St-Laurent-du-Var - Lyon)
Introduction
Colonoscopy has become a first intention examination in colonic pathology. Nevertheless, the safety of the
procedure, the accuracy of the diagnosis and the precision of the therapeutic approach are directly related to
the acceptability of the colonic preparation because only an efficient preparation ensures that the mucosa can
be properly observed and that the endoscope will progress without danger in a perfectly clean colon.
l Fordtran’s solution (2) associating polyethylene glycol (PEG 4000, a high molecular weight osmotic agent
of low absorbency and not active in the metabolism of dissacharides), with various salts (low-absorption
sodium sulfate, sodium chloride and bicarbonate, potassium chloride) is used to obtain an excellent preparation
without absorption or secretion of water and electrolytes. It is now routinely used and advantageously replaces
the techniques that were previously employed.
l With the methods associating dietary measures and purgatives, commonly used before a baryum enema,
colonic preparation is only partial, especially in the ascending colon.
l The techniques of saline irrigation administered either through a gastric catheter (4) or without it (5) are
potentially dangerous because of the risk of water and electrolyte retention associated with them.
l At first, colonic cleansing with a mannitol solution was favorably accepted, but has since been abandoned
because of the higher risk of colonic explosion during electrosurgery (1).
The efficacy of Fordtran’s solution, based on a wide experience, is now well established. With it, a safe
endoscopic examination is now possible, from the rectum to the Bauhin’s valve, with a good visibility of the
mucosa, without false abnormal images and iatrogenic irritation, even in the case of a fragile colon. In the
descending phase, the diagnosis of small tumors is made notably easier.
However, the quality of the colonic preparation with PEG 4000 may be limited by the difficulty for the patient
to ingest the necessary amount of the solution (4 liters) and by its unpleasant taste. To remedy these difficulties,
fractioning the doses (6,8) and giving the solution a satisfying flavor (Fortrans®)*** have been recommended.
To give a precise indication of the efficacy of these measures, the Société Française d’Endoscopie Digestive
(French Society of Digestive Endoscopy), in collaboration with the Laboratoires Beaufour, has carried out a
multicentric study**** on colonic preparation with Fortran®, using one or two doses.
* Institut A. Tzanck, 06700 St-Laurent-du-Var (France)
** Hôpita1 Croix Rousse, 69000 Lyon (France)
*** Beaufour Laboratories
**** with the participation of R. Castro (Marseille), J. Delmont (Nice),
C. Florent (Paris), M. Greff(St-Laurent-du-Var), Ph. Houcke (Lille), J.
Laurent (Nancy). B. Ljunggren (Nice), Cl. Maffioli (Reims), A. Pupazian
(Amiens), J.F. Rey (St-Laurent-du-Var), J.C. Souquet (Lyon).
Adapted from Médecine et Chirurgie Digestives - 1990 - 19 - N°8 - p. 507 - 511
Methodology ofthestudy
In August and September 1990, after a
favorable decision of the Ethics Committee,
eleven centers ****, either in hospital or private
practice, participated in this randomized trial.
The purpose of this work was to determine if
the two-phase mode of administration would
create the best technical conditions and facilitate
the patient’s acceptance of the FortransB
preparation.
FortransB : a flavored product administered
per os, containing mostly PEG 4000, sold in
boxes of 4 small packets.
I Patients
l The study included patients over 18 years of
age who were to have a colonoscopy, without
contraindication to this type of examination,
nor previous colonic surgery. Their written
consent was received after they were informed of
the modalities of the study.
Two hundred and eight patients were
included in the study; because four medical
records were incomplete, only 204 cases were
analyzed (n = 103 in the <<one-dose>> group; n =
101 in the <<two-dose>> group). They included 92
men (45 %) and 112 women (55 %). Their mean
age was 57 + 15 (from 20 to 88). The distribution
by age is given in Fig. 1.
I Mode of preparation
Patients were randomly distributed in two
groups:
<<Two-dose>> protocol
l Starting at 5 p.m. on the day before the
examination, the patient ingested 2 packets of
FortransB diluted in 2 liters of fresh water (on the
basis of one liter per hour); this was followed
with a light meal;
l In the morning of the examination day,
starting at 6 a.m., the patient ingested 2 packets
of FortransB diluted in 2 liters of fresh water.
<<One-dose>> protocol
l Starting at 5 p.m. on the day before the
examination, the patient ingested 4 packets of
FortransB diluted in 4 liters of fresh water until
a clear liquid rectal effluent was obtained.
I Collecting information
Before the examination, the patient filled a
questionnaire concerning the amount of
FortransB ingested, the tolerance and the taste of
the solution (9 questions).
l
Fig. 1 - Distribution by age group.
Adapted from Médecine et Chirurgie Digestives - 1990 - 19 - N°8 - p. 507 - 511
The endoscopist who was not informed of
the way the colonic preparation was carried out,
assessed its quality, the visibility of the Bauhin’s
valve and the tolerance of the product. The
cleansing of each explored colonic segment was
scored from 0 to 4:
- 0: no fetal material or residual liquid,
- 1: no solid fecal material, clear residual
liquid,
- 2: no solid fecal material, unclear liquid,
easily aspirable,
- 3: presence of solid fecal material and of
unclear liquid, with no effect on the reliability of
the examination,
- 4: reliable examination impossible, according
to a global score established by adding segment
scores.
The statistical analysis was based on the
following tests: Student’s Tj Mann and Whitney’s
2
U and X .
Results
Colonoscopy was performed under
twilight anesthesia in 95 % of the cases.
l The most frequent indications for
endoscopy were: various digestive symptoms
(59 %), control after polypectomy (29 %) or
polypectomy (11 %) (Fig.2).
l
Fig. 3 - Colonic cleansing score (p < 10 -4).
Fig.2 - Distribution by age and reason for colonoscopy.
Overall score: visibility of Bauhin’s valve
The overall score was established by the
summation of segment scores and confirmed the
superiority of the <<two-dose>>, preparation [Table II).
I Quality of the <<Two Dose>> Preparation
Score for each segment
The quality of the colonic preparation was
assessed on the basis of the colonic cleansing
in each explored segment.
Comparative results, given for each
segment, for both modes of administration are
given in a summary table (Table I).
The cleansing of each segment may be
indicated by a mean score (mean + s.d.). In all
explored segments, the difference between
mean scores was statistically significant in
favor of the <<two-dose>> group (Fig.3.).
Table II - Overall score and mode of administration.
This score was established on the observation of
177 patients with a complete colonoscopy and of
13 patients whose colonoscopy had been incomplete
because of a poor preparation [unseen segments
scored 4) of whom 11 belonged to the <<one-dose>>
group and 2 to the <<two-dose>> group. Fourteen
patients were not included in this score (10 in the
<<cone-dose>>, group and 4 in the <<two-dose>> group)
because an obstacle prevented a complete colonoscopy.
Table I - Colonic segment cleansing (in % of patients in each group).
Adapted from Médecine et Chirurgie Digestives - 1990 - 19 - N°8 - p. 507 - 511
The visibility of the Bauhin’s valve is significantly
judged to be better in the <<two-dose>> group
-4
(p<10 ) (Table III).
Table III - Visibility of Bauhin’s valve and mode of administration.
I Two doses: A better Acceptability
Fractioning the substance used for colonic
preparation improves its acceptability: more patients
of the <<two-dose>> group ingested at least 3.5 liters (89
% versus 77 %, p = 0.018). If half of the subjects
mentioned side effects that are commonly seen in all
colonic preparations (upset stomach, nausea, even
vomiting), the occurence of an upset stomach was
significantly higher in the <<one-dose>> group (p =
0.026). 73 % of the patients who ingested FortransB
in two doses found it either good or satisfactory,
versus 59 % in the <<one-dose>> group. This difference
is statistically significant (p = 0.039). This explains
why colonic preparation is more often abandoned by
patients receiving FortransB in one dose. In fact,
the preparation went on with up to 4 liters for 65 %
of the <<cone-dose>> group subjects and for 72 % of
those of the <<two-dose>>, group.
Discussion
Total colonoscopy has become a routine
procedure for colonic investigations. It has become
easier with the development of ambulatory
anesthesia and the greater availability of PEG 4000
administered per OS for colonic preparation.
The population of this study is representative of
that for which a lower digestive tract endoscopy is
performed in gastroenterology practice. The mean age
corresponds to the age at which colonic examination
is most useful to detect the presence of polyps. In
fact, in 40 % of the cases, a colonoscopy was
performed to verify the absence of recurrence of a
polyp or to remove one.
The preparation to colonscopy must be well
accepted by the patient, with good tolerance and
Adapted from Médecine et Chirurgie Digestives - 1990 - 19 - N°8 - p. 507 - 511
efficacy. A high quality colonic cleansing is necessary
to perform a good procedure, whether its purpose is
diagnosis or therapy.
A previous study (3) has shown the advantage of
fractioning doses to increase the acceptability of
FortransB and the quality of the preparation. The
results have been confirmed by this multicentric
study.
Normally, when it is necessary to ingest 3 to 4 liters
of solution, it becomes difficult to avoid a repulsive
feeling, nausea, or even vomiting. This may limit the
ingestion of PEG and could compromise the efficacy
of the colonic preparation. Fractioning the dose
makes it easier to absorb. Side effects, especially a
difficulty to continue drinking the solution, are less
marked in the <<two-dose>> group and patients ingest
more easily the necessary amount when dose
fractioning takes place. With a better acceptability,
the quality and the efficacy of the preparation
increase. The overall score of colonic cleansing, as
well as those established for each segment, from
the rectum to the end of the cecum are significantly
-4
better (p<10 ) in the <<two-dose>>, group.
Therefore, the fractioned administration (2 liters
t 2 liters) of FortransB is well tolerated, even by a
fragile mucosa, and the better visibility facilitates a
more precise diagnosis. A quasi-systematic twilight
anesthesia increases tolerance to the colonoscopy, as
well as its acceptability and efficacy.
Besides the amount of fluid to ingest, another
key parameter in the acceptance of colonic
preparation may be the taste of the product. To
emphasize this point, two centers (J.F. Rey and J.S.
Delmotte) (7) have carried out a double-blind study,
comparing Fortran® with a non-flavored PEG
solution. This study included 77 patients, randomly
distributed in two groups statistically comparable,
except for the distribution by sex (more women in
the <<flavored solution>> group). Colonoscopy was
complete in 65 cases (in 12 patients, the examination
had to be interrupted for the following reasons: 1
stenosis, 1 poor preparation and 10 cases with pain
in non-anesthetized patients). With the flavored PEG
solution (Fortran®), Bauhin’s valve was seen in 94
% of the cases versus 69 % with the non-flavored
solution.
The results regarding tolerance did not
statistically differ between the two groups (patients
could not describe accurately salted, sweet or bland
tastes). With flavored PEG 4000, nausea occurred
later and the patients drank more easily the 4 liters.
At the time of a final evaluation, the physician noted
a better tolerance with the flavored solution (74 %
with Fortrans® versus 55 %).
Therefore, the acceptability of colonic preparation
is linked to flavor, but also to the amount of fluids
to ingest. This explains how fractional doses improve
the results.
Conclusions
More and more frequently, total colonoscopy has
become a routine examination for diagnosis and
therapy, replacing the other methods.
It was made easier with the development of
ambulatory anesthesia and the only remaining
problem was that of the acceptability of the amount
and taste of the ingested product.
Adding flavor to the solution (Fortran®) hides its
salty taste, unpleasant for many patients, and renders
it easier to accept.
This study confirms the interest of fractional
PEG 4000 doses to facilitate the ingestion of 4 liters
of solution and to improve the tolerance and quality
of colonic preparation.
REFERENCES
Adapted from Médecine et Chirurgie Digestives - 1990 - 19 - N°8 - p. 507 - 511