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Original Research |
1 Radiology Department, Southern General Hospital, 1345 Govan Rd., Glasgow, UK
G51 4TF.
2 Department of Radiology, Victoria Infirmary, Glasgow, Scotland.
3 Department of Radiology, Southern General Hospital, Glasgow, Scotland.
Received June 1, 2005;
accepted after revision July 29, 2005.
Address correspondence to G. Low
(timgy{at}yahoo.com).
Abstract
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SUBJECTS AND METHODS. A prospective randomized study was conducted over a 1-year period after institutional review board approval. Two hundred twenty-three patients (102 men, 121 women; median age, 68 years; age range, 50-94 years) were randomized to retention balloon or standard tip catheter after giving informed consent. Barium incontinence was graded A (did not lead to examination failure) or B (led to examination failure).
RESULTS. One hundred thirteen patients (51%) were examined with retention balloon catheters and 110 patients (49%) with standard tip catheters. In the retention balloon catheter group, 26 patients (23%) were incontinent (22 [19.5%] grade A, four [3.5%] grade B). In the standard tip catheter group, 31 patients (28%) were incontinent (24 [21.8%] grade A, seven [6.4%] grade B). No significant difference was seen in incontinence rates between the two catheter groups (p = 0.54, chi-square test). Sixteen patients (7.2%) gave a prior history of fecal incontinence. Of these, 15 (94%) developed incontinence, and in seven (44%), grade-B incontinence led to examination failure.
CONCLUSION. Retention balloon catheters have no advantage over standard tip catheters at preventing barium incontinence. Given the possible higher rates of rectal trauma associated with retention balloon catheters, their use may not be justified. A prior history of fecal incontinence is a strong predictor of examination failure.
Keywords: barium • catheter • colonoscopy • enema • fluoroscopy • gastrointestinal radiology
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Our study sought to determine whether retention balloon catheters are superior to standard tip catheters in preventing barium incontinence by comparing incontinence rates in patients undergoing DCBE with one or the other catheter type.
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Examinations were performed on a Philips Medical Systems Easy Diagnost 90 or Toshiba Fluorex DUA-450A fluoroscopy unit by one of a team of two radiologists and two radiographers who had been trained to perform DCBE independently. Patients were randomized to have DCBE performed with either retention balloon catheter (Henley barium enema tips with silicone inflatable retention cuff, reference number 8825-H, Henleys Medical Supplies Ltd.) or standard tip catheter (Henley barium enema tips, reference number 9509-H, Henleys Medical Supplies Ltd.) (Fig. 1). We asked all subjects about a prior history of fecal incontinence before commencing the examination. All rectal catheters were lubricated and inserted with patients positioned in the left lateral decubitus position. Fluoroscopy was used to confirm correct catheter position in the rectum before barium instillation. When a retention balloon catheter was used, it was inflated to the degree that the patient could tolerate. In addition, in cases where we suspected the patient might develop incontinence, we applied gentle traction on the balloon catheter against the anal sphincter to create a sealant effect against incontinence. When a standard tip catheter was used instead, tape was applied to secure the catheter to the buttocks. A standard 400-mL bag of Tyco EPI-C 150% weight/volume (w/v) barium sulfate suspension was used and placed at a set height of 0.9 m above the fluoroscopy tabletop.
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If barium incontinence occurred during examination, it was graded as either A or B. Grade-A incontinence signified mild barium incontinence that did not hinder completion of the examination. Grade-B incontinence signified moderate to severe barium incontinence that led to a critical degree of soiling and abandonment of the examination. In cases of grade-B incontinence, the examination was resumed with the opposing catheter type to assess whether it changed the barium incontinence grade.
We recorded any significant examination complications and whether antispasmodics were administered. In our practice, antispasmodics are not used routinely. However, when IV antispasmodics were needed, either 20 mg of hyoscine butylbromide (Buscopan; Boehringer Ingelheim) or 1 mg of glucagon hydrochloride (GlucaGen Hypokit, Novo Nordisk) was administered.
Statistical Analysis
All calculations were performed with Graph-Pad Software (Quickcalcs and
StatMate 2 for Windows, Microsoft). The chi-square test and Fisher's exact
test were used to compare incontinence rates in the retention balloon and the
standard tip catheter groups. The Mann-Whitney test and Fisher's exact test
were used to assess for significant age and sex differences, respectively,
between the two groups. For all calculations, p values were
two-sided, with a p value of less than 0.05 considered statistically
significant.
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In the retention balloon group, 26 patients (23%) were incontinent of barium (22 [19.5%] grade A, four [3.5%] grade B). In the standard tip catheter group, 31 patients (28%) were incontinent (24 [21.8%] grade A, seven [6.4%] grade B).
No significant difference was seen in the frequency of grade-A or grade-B incontinence between the two catheter groups (p = 0.54, chi-square test). There was also no significant difference between the two catheter groups for overall (combined grades A and B) incontinence rates (p = 0.44, Fisher's exact test). The relative risk of incontinence (grades A and B) with a standard tip catheter compared with a retention balloon catheter was 1.225 (95% CI, 0.78-1.92). In the retention balloon catheter group, the four patients with grade-B incontinence retained this grade on repeat examination with the opposing catheter type. In the standard tip catheter group, of the seven patients with grade-B incontinence, three had their grade improved to A with a retention balloon catheter, while four remained grade B.
Sixteen patients (7.2%) had a prior medical history of incontinence (six patients [5.3%] in the retention balloon catheter group, 10 [9.1%] in the standard tip catheter group). Fifteen of these patients (94%) were incontinent; five (83%) of those in the retention balloon group, 10 (100%) of those in the standard tip group. Seven patients (44%) suffered grade-B incontinence, three (50%) in the retention balloon group and four (40%) in the standard tip group.
A prior history of incontinence was clearly a confounding factor, and there were more such patients in the standard tip group. Excluding patients with a prior history of incontinence from the analysis reduces the relative risk for incontinence with a standard tip catheter to 1.02 (95% CI, 0.57-1.8), suggesting the higher frequency of patients with a prior history of incontinence in the standard tip group accounts for almost all the small observed increased frequency of incontinence with standard tip catheters.
Ten patients (4.5%), four in the retention balloon catheter group and six in the standard tip catheter group, received antispasmodics during the examination. Of these, five patients (50%) had grade-A incontinence (two in the retention balloon catheter group, three in the standard tip catheter group), and one patient in the standard tip catheter group had grade-B incontinence.
No major complications occurred in the study and, in particular, there were no cases of rectal trauma or perforation.
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This perceived advantage has led some radiologists to believe that retention balloon catheters are superior to standard tip catheters in preventing incontinence during examinations. Incontinence prevention is desirable, as it may lead to higher rates of technical examination completion, shorter examination times (incontinence incurs a time delay because of clean up), and reduced radiation exposure (lower probability of repeating part of the examination), all while maintaining patient dignity. Fewer failed barium enemas may also reduce the need for subsequent diagnostic colonoscopy.
Early barium enema studies from the 1950s to the 1970s [3-9] suggested a higher rate of rectal trauma and perforation for retention balloon catheters. More modern retention balloon catheter designs may be safer, with balloons engineered to inflate symmetrically and to a predetermined volume using an inflation-limiting device. A more recent study by Blakeborough et al. [1] found no difference in the mortality rate or intraperitoneal perforation rate during DCBE between the two catheter types, but did note an increase in the extraperitoneal perforation rate of a retention balloon catheter over a standard tip catheter by a factor of 2.6 (retention balloon catheter: eight out of 206,409 patients; standard tip catheter: eight out of 531,807 patients). Blakeborough et al. suggested that this increased risk of extraperitoneal perforation may be exaggerated, as many radiologists reserve retention balloon catheters for elderly or incontinent patients, a group at higher risk of complications.
We only recruited patients who were 50 years or older to obtain a study population with a higher likelihood of developing incontinence. The age of 50 years was used as an arbitrary cutoff for this purpose. Stewart et al. [12] showed that incontinence rates increase with age. In their study of 306 barium enema patients, they found that in patients 60 years old or less, incontinence occurred in 5% or less of men and in 10% of women, but rose sharply after this age. By the ninth decade, the incidence of incontinence rose to approximately 50% for both sexes. In clinical practice, some radiologists may favor the use of a retention balloon catheter on the basis of a patient's advanced age [1].
We excluded patients with active anorectal disease, recent full-thickness rectal biopsy, known rectal neoplasm, rectal stricture, or radiation therapy, as previous reports have suggested that use of a retention balloon catheter in such conditions is associated with an increased risk of rectal trauma and perforation [1, 2, 14-16].
We found no significant difference in incontinence rates between the retention balloon catheter group (26 of 113, 23%) and the standard tip catheter group (31 of 110, 28%). This suggests that the perception that retention balloon catheters are better than standard tip catheters at preventing incontinence may be misleading. For incontinent patients, grade-A incontinence was at least three times more common than grade-B in both groups, such that the majority of incontinent patients were still able to have their barium enema completed successfully. For grade-B incontinent patients, both catheter types performed poorly, with eight out of the 11 patients remaining grade B on repeat examination with the opposing catheter type. In three patients, however, the change from a standard tip to a retention balloon catheter resulted in the incontinence grade improving from B to A and therefore in successful examination completion. Thus, a retention balloon catheter may have an occasional use for rescuing a failing study.
It is therefore important to be able to predict which patients are likely to suffer significant incontinence before undertaking a barium enema. Stewart et al. [12, 17] found that poor anal tone by digital assessment was a good predictor of a patient's likelihood of developing examination incontinence. Alternatively, a history of prior fecal incontinence may predict examination incontinence. In our study, 16 patients (7.2%) gave a prior history of fecal incontinence. Of these, 13 (81%) developed barium incontinence, and in seven (44%), grade-B incontinence led to examination failure. Moreover, of the 11 patients in the overall study (4.9%) who developed grade-B incontinence, eight (72.7%) gave a prior history of fecal incontinence. A prior history of fecal incontinence is a strong predictor of examination incontinence. Because DCBE failed in almost half of these cases, an alternative examination may be more appropriate for patients with such a history.
Our study has several limitations. First, there may have been subtle but unavoidable interoperator and intraoperator differences in DCBE technique, including the volume of balloon inflation and degree of air insufflation. It is uncertain if these differences have any influence on incontinence.
We did not routinely use antispasmodics. Some authors advocate the use of antispasmodics routinely for DCBE [18-21]. Antispasmodics are believed to improve colonic distention and decrease the amount of discomfort patients experience from bowel spasm [22, 23]. Some authors also believe that antispasmodics aid in preventing incontinence [10, 24, 25], possibly by a reduction in intracolonic pressure as a result of bowel relaxation. If this were so, more liberal use of antispasmodics would be expected to reduce incontinence rates further. Only 10 patients (4.9%) received antispasmodics, and this number was felt to be too small to have a significant bearing on our findings.
In conclusion, no significant difference was found in incontinence rates for patients who had DCBE performed with either a retention balloon catheter or a standard tip catheter. This goes against the existing perception that retention balloon catheters are superior in this respect. The routine use of retention balloon catheters may not be justified, as they may be associated with higher rates of rectal trauma while not incurring significant benefit over standard tip catheters at preventing incontinence.
Acknowledgments
We thank the following people for their contributions to the study: Grant
Urquhart and Ian McLaughlin, for their support and enthusiasm for this
project; and Karen McGugan, Linda Burns, and their respective dedicated
nursing teams, for sharing in our daily endeavors of performing barium enemas
and for providing much-appreciated assistance. We also would like to extend
our gratitude to Alex McConnachie, consultant statistician from the Robertson
Centre for Biostatistics, University of Glasgow, for providing us with
much-appreciated statistical advice and analysis. Most of all, we thank all
the patients who agreed to take part in our study; without them, this study
would not be possible.
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