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Gastrointestinal Imaging |
1 From the Departments of Radiology (J.F., R.E.v.G., S.J., B.H., J.S.), Public Health Epidemiology (E.B., G.J.B.), Gastroenterology and Hepatology (J.F.B.), and Clinical Epidemiology & Biostatistics (P.M.M.B.), Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands; Departments of Radiology (S.J., V.P.M.v.d.H.) and Gastroenterology (A.v.d.S.V.), Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands; and Department of Gastroenterology, Slotervaart Hospital, Amsterdam, the Netherlands (P.S.). Received July 22, 2006; revision requested July 27; revision received December 9; accepted January 15, 2007; final version accepted March 7. Supported by grant 2100.0094 from the Netherlands Organization for Health Research and Development. Address correspondence to J.F. (e-mail: j.florie{at}amc.uva.nl).
| ABSTRACT |
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Materials and Methods: This study had institutional review board approval; all participants gave written informed consent. In this multicenter study, consecutive participants undergoing conventional colonoscopy because of a personal or family history of colorectal cancer or adenomatous polyps underwent MR colonography 2 weeks prior to colonoscopy. They all followed a low-fiber diet and were given lactulose and an oral contrast agent (fecal tagging with gadolinium) 2 days before colonography. Before imaging, spasmolytics were administered intravenously, and a water–gadolinium chelate mixture was administered rectally for distention of the colon. Breath-hold T1- and T2-weighted sequences were performed in the prone and supine positions. Participant experience in terms of, for example, pain and burden was determined by using a five-point scale and was evaluated with a Wilcoxon signed rank test; participant preference was determined by using a seven-point scale and was evaluated with the
2 statistic after dichotomizing.
Results: Two hundred nine participants (77 women, 132 men; mean age, 58 years; range, 23–84 years) were included. One hundred forty-eight participants received sedatives (midazolam) and/or analgesics (fentanyl) during colonoscopy. Participants rated the MR colonography bowel preparation as less burdensome (P < .001) compared with the colonoscopy bowel preparation (10% and 71% of participants rated the respective examinations moderately to extremely burdensome). Participants also experienced less pain at MR colonography (P < .001) and found MR colonography less burdensome (P < .001). Immediately after both examinations, 69% of participants preferred MR colonography, 22% preferred colonoscopy, and 9% were indifferent (P < .001, 69% vs 22%). After 5 weeks, 65% preferred MR colonography and 26% preferred colonoscopy (P < .001).
Conclusion: Participants preferred MR colonography without extensive cleansing to colonoscopy immediately after both examinations and 5 weeks later. Experience of the bowel preparation and of the procedure was rated better.
© RSNA, 2007
| INTRODUCTION |
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Because patient-related factors such as fear of pain and concerns about bowel preparation are barriers to screening (4), good patient acceptance is important, and strong willingness to undergo CT colonography is encouraging for a screening test (5). MR colonography with limited bowel preparation (fecal tagging by using a contrast agent and sometimes lactulose together with a low fiber diet) (6–8) could be a valuable screening tool for colorectal cancer because it is safe, it does not require radiation, and above all, it is supposedly patient friendly. Although acceptance of CT and MR colonography has been studied, the focus has been mainly on CT colonography (9–15), despite the fact that MR colonography has shown promising results regarding accuracy (16–19) and is more preferable for screening a large number of participants because no ionizing radiation is required. Only a few studies briefly report on patient acceptance of MR colonography (20,21).
Thus, the purpose of this multicenter study was to prospectively evaluate participants' experience and preference of MR colonography with limited bowel preparation compared with colonoscopy in participants at increased risk for colorectal cancer.
| MATERIALS AND METHODS |
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Questionnaires
All participants underwent MR colonography with limited bowel preparation approximately 2 weeks before conventional colonoscopy. They filled out six questionnaires at different time points (see below) to evaluate their opinion toward screening for the general population ("Would you participate in a screening program?"), expectations of MR colonography and colonoscopy, experience with the limited bowel preparation, experience with the standard colonoscopy bowel preparation, experience with MR colonography and colonoscopy, and their preference for their next examination (with the assumption that in 20% of MR colonography examinations clinically relevant lesions would be shown, necessitating that the participant still undergo therapeutic colonoscopy). The first questionnaire was filled out on the basis of preexisting knowledge and the information that was provided by phone and by additional written materials about the study. If participants did not return questionnaire 6 (which was sent by mail), a new questionnaire was sent to them. If they did not respond to this repeat questionnaire, they were called by the investigator (J.F.) or an administrative staff member and kindly reminded to fill out the questionnaire, and another questionnaire was sent. No further action was taken if they did not respond at this time.
For evaluating participants' experience (see below), five-point Likert scales with commonly used qualifiers (no, mild, moderate, severe, extreme) were used, whereas for preference, a seven-point Likert scale (definitely MR colonography, probably MR colonography, possibly MR colonography, indifferent, possibly colonoscopy, probably colonoscopy, definitely colonoscopy) was used.
Limited Bowel Preparation before MR Colonography
All participants were prepared with a low-fiber diet, lactulose, and an oral contrast agent 48 hours before MR imaging. All were sent a list summarizing what dietary measures were necessary (no fiber-rich food, no nuts). The lactulose (12 g Lactulose CF powder [6 g per sachet]; Centrafarm, Etten-Leur, the Netherlands) was dissolved in water and taken both days before MR colonography in the morning for stool softening. If the stool became too soft, participants were allowed to reduce the amount of lactulose (asked in questionnaire 2). Ten milliliters of a gadolinium chelate (gadopentetate dimeglumine 0.5 mmol/mL, Magnevist; Schering, Berlin, Germany) was added to all major meals during this period (six meals over 2 days) for stool tagging. Questions about stool consistency (diarrhea, soft stool, normal shaped), abdominal pain (yes, no), and flatulence (yes, no) were asked in questionnaire 2.
MR Colonography
MR colonography was performed at the Academic Medical Center or the Onze Lieve Vrouwe Gasthuis by one of two research fellows (J.F. and S.J., both with 3 years of experience) or by one of six specially trained technologists (average experience, 25 years; range, 10–35 years) with extensive experience in the procedure.
Before imaging, a flexible balloon-tipped catheter was placed in the rectum. A spasmolytic agent (butylscopolamine bromide 20 mg, Buscopan; Boehringer-Ingelheim, Ingelheim, Germany) (or, when Buscopan was contraindicated, glucagon hydrochloride 1 mg, Glucagen; Novo-Nordisk, Bagsvaerd, Denmark) was administered intravenously. The colon was distended with a water-gadolinium mixture (10 mmol/L) with 80 cm of hydrostatic pressure created by raising the bag. Filling of the colon was stopped when participants reported pain or felt uncomfortable. Before a participant was imaged, a preview image was obtained to determine whether adequate distention of the bowel was achieved. If necessary, additional fluid was added if participants agreed.
The MR imaging sequences were performed with a 1.5-T imaging unit (Signa, GE Healthcare, Milwaukee, Wis; or Intera, Philips Medical Systems, Best, the Netherlands) or a 3.0-T imaging unit (Intera, Philips Medical Systems) by using a phased array coil. The MR colonography protocol consisted of a coronal three-dimensional T1-weighted fast field-echo sequence (performed during five, four, or one or two breath holds, repectively, according to the imaging unit used), a coronal two-dimensional T2-weighted fast spin-echo sequence (performed during three, two, or two breath holds, respectively), and a transverse two-dimensional T2-weighted fast spin-echo sequence (performed during free breathing or two or four breath holds, respectively). All sequences were performed in the prone and supine positions. Only the transverse T2-weighted turbo spin-echo sequence on the 1.5-T Signa unit was performed in free breathing. All breath holds took 10–20 seconds. MR colonography took, on average, 45 minutes.
The spasmolytic agent used, the amount of fluid administered (estimated in liters), and the amount of any leakage (no, little or a spot, minor, severe) were noted.
Colonoscopy
Participants ingested 4 L of polyethylene glycol electrolyte solution (KleanPrep; Helsinn Birex Pharmaceuticals, Dublin, Ireland) for bowel preparation the day before conventional colonoscopy (if the examination was performed in the morning) or 2 L on the day before and 2 L on the day of the examination (if the examination was performed in the afternoon). If necessary, additional solution was ingested. Participants were not allowed to eat after starting the bowel preparation. The exact amount of bowel preparation taken was asked in questionnaire 4.
The colonoscopy was performed with a standard colonoscope (CF-Q160AL or CF-Q160L; Olympus, Tokyo, Japan) in the endoscopy department of the Academic Medical Center, the Onze Lieve Vrouwe Gasthuis, or Slotervaart Hospital. During colonoscopy, the use of analgesics (0.05 mg of fentanyl [Fentanyl-Janssen; Janssen Pharmaceuticals, Beerse, Belgium]) and sedatives (5 mg of midazolam [Dormicum; Roche, Basel, Switzerland]), examination time, presence of polyps, and the physician who performed the examination (staff members J.F.B., A.v.d.S.V., or P.S. [n = 19] or one of 10 gastroenterology fellows under the direct supervision of the attending gastroenterologist [average experience of staff members, 15 years; range, 3–25 years]) were recorded. If the colonoscopy was considered nondiagnostic because of insufficient bowel preparation or incomplete visualization, a re-endoscopy was performed (insufficient bowel preparation [n = 1, with same-day re-endoscopy], incomplete visualization [n = 5, with re-endoscopy within 1 day to 6 weeks]). Questionnaires completed after initial colonoscopy were used for analysis of participant acceptance.
Statistical Analysis
The Wilcoxon signed rank test was used to evaluate differences in experience between MR colonography and colonoscopy, to evaluate differences in preference between questionnaire 5 and questionnaire 6, and to evaluate differences in attitude toward screening (questionnaire 1 vs questionnaire 6). To test for statistically significant differences associated with a preference for either MR colonography or colonoscopy, the data were first dichotomized (preference for MR colonography vs preference for colonoscopy; data from indifferent participants were not included in this analysis). A
2 test was used to determine whether the proportion of participants preferring MR colonography (among participants with a clear preference) was higher than 50% (the percentage of subjects that can be expected to prefer MR colonography if in fact subjects do not tend to prefer one procedure over the other).
The Mann-Whitney test was used to test the effect of use of sedatives and analgesics (participants who received more heavy sedation, requiring both sedatives and analgesics, vs participants who received no sedation) on preference rated with a seven-point scale.
Logistic regression was used to evaluate factors potentially related to preference for either MR colonography or colonoscopy. Only covariates associated with a P value of .10 or lower were considered for inclusion in the logistic regression model. A multivariable model was then built by using a stepwise forward selection strategy. The participant-related factors used were as follows: sex, age of 60 years or greater, income of 32 000 U.S. dollars (mean net annual income per Dutch household) or greater, completion of academic or higher vocational education, personal history of colorectal polyps or cancer, indication for surveillance (personal history of colorectal carcinoma, personal history of polyps, family history of colorectal carcinoma or polyps), the amount of water used for distention, previous painful endoscopy (no and mild vs moderate, severe, and extreme pain), who performed the colonoscopy (gastroenterologist, gastroenterology fellow, surgeon), use of sedatives and use of analgesics during colonoscopy, presence of polyps at colonoscopy, and experience parameters as experienced on the day of the examination (burdensome bowel preparation at MR colonography or colonoscopy, painful MR colonography or colonoscopy, burdensome MR colonography or colonoscopy [no and mild vs moderate, severe, and extreme burden]). Data from indifferent participants were not included in the logistic regression analysis. P < .05 was considered to indicate a statistically significant difference.
| RESULTS |
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One hundred seventy-four participants were imaged at 1.5 T, and 35 were imaged at 3.0 T. Forty-two of the 174 participants were imaged at the secondary referral center. On average, 1.9 L ± 0.7 of water-gadolinium mixture was used to fill the colon. In most participants (93%, n = 195), no leakage was observed.
Participants' Experience
Before both examinations (questionnaire 1) participants were most reluctant to undergo colonoscopy, second-most reluctant to undergo the bowel preparation before colonoscopy, and then most reluctant to undergo MR colonography. Participants were least reluctant to undergo the fecal tagging. Immediately after the examinations (questionnaire 5), the bowel preparation before colonoscopy was rated as the most unpleasant factor, the colonoscopy was rated as the second-most unpleasant factor, MR colonography was rated as the third-most unpleasant factor, and fecal tagging was rated as the least unpleasant factor. Results of questionnaire 6 were the same as immediately after both examinations.
In terms of how participants rated the different aspects of the bowel preparation prior to MR colonography (Fig 2), lactulose was found to be the most burdensome and the contrast agent to be least burdensome.
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The most burdensome aspect of MR colonography was the filling with water (Table 4). The second-most burdensome feature was the multiple breath holds necessary for imaging. The most burdensome aspect of colonoscopy was reported to be the movements of the scope, followed by the insufflation of gas.
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No statistically significant difference in preference was seen between the participants who required both sedatives and analgesics and participants who did not receive medication (questionnaire 5: P = .19; questionnaire 6: P = .53). Both groups preferred MR colonography to colonoscopy, both in questionnaire 5 and questionnaire 6 (the questionnaire completed by mail). The numbers of participants preferring MR colonography, participants with no preference, and participants preferring colonoscopy, respectively, were 32 (63%), five (10%), and 14 (27%) of 51 participants for the no-sedation group and 69 (73%), eight (8%), and 18 (19%) of 95 participants for the sedation and analgesics group. After 5 weeks (questionnaire 6), these numbers were 33 (62%), six (11%), and 14 (28%) of 53 participants and 73 (66%), 11 (10%), and 27 (24%) of 111 participants, respectively.
Determinants of Preference
In the logistic regression analysis, the presence of polyps (odds ratio, 4.3; P = .008), a burdensome MR colonography bowel preparation (odds ratio, 10.2; P = .004), a burdensome (in terms of overall examination rating) MR colonography examination (odds ratio, 9.8; P < .001), and a not-burdensome colonoscopy examination (odds ratio, 4.7; P = .011) were identified as significant determinants of preference for colonoscopy as expressed in questionnaire 5. For the preference expressed in questionnaire 6, a burdensome (in terms of overall examination rating) MR colonography examination (odds ratio, 3.5; P = .012) was a significant determinant of preference for colonoscopy following the results of the multivariable models.
Attitude toward Screening
Prior to participation, 95% (160 of 169) of participants said they would (probably) take part in screening programs of the general population when invited, 4.7% (eight of 169) were indifferent, and 0.6% (one of 169) said he or she would probably not participate. In questionnaire 6, 91% (169 of 185) of participants said they would (probably) participate, 6.5% (12 of 185) were indifferent, and 2.2% (four of 185) said they would (probably) not participate (no statistically significant change).
| DISCUSSION |
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Results regarding patient acceptance were promising. This can be attributed to the limited bowel preparation with a gadolinium chelate, which has a neutral taste. The study by Goehde et al (20), in which barium was used for fecal tagging and water was used for rectal filling, revealed disappointing results for MR colonography because barium intake was considered as burdensome as the bowel cleansing before colonoscopy and the MR colonography examination was regarded as more distressing than the colonoscopy examination. Because our previous experience was similar, we used a gadolinium chelate in our study.
The most burdensome aspect of MR colonography was reported to be the filling with water. Morrin et al (21) state that two participants who underwent MR colonography with enema and then MR colonography with air for distention both preferred bowel distention with air. They state that the use of MR colonography with water for distention may be limited by discomfort, embarrassment, and soiling. Even though soiling and leakage were limited in our study, it can be assumed that distention with air would be preferred by participants. Unfortunately, we have no experience with air for rectal filling (dark lumen), and the use of gadolinium for fecal tagging (making feces hyperintense on T1-weighted images) in theory is the most patient-friendly solution. In an explorative study, no significant differences were seen in acceptance between a group of participants in whom water was used for rectal filling and a group in whom air was used for rectal filling (both groups took barium for fecal tagging) (23). Other possible options for improving acceptance are reducing the number of breath holds (second-most burdensome aspect) by scanning fewer positions or sequences, the use of improved hardware and software facilitating fewer breath holds, and the use of a higher dose of spasmolytics.
Most of our participants (69%) preferred MR colonography with limited bowel preparation to colonoscopy with extensive cleansing (22%). After 5 weeks, there was a slight shift toward colonoscopy. A comparable shift in preference in time has been observed in a study in which acceptance of CT colonography and colonoscopy (both performed after extensive bowel preparation) were compared (10). In this study, pain experienced during the procedures was also rated lower after 5 weeks. In contrast to pain with colonoscopy, which participants seem to "forget," bowel preparation was rated as significantly more burdensome after 5 weeks than directly after the examination.
MR colonography with limited bowel preparation is mainly suitable for populations for whom there is only a small chance of having to undergo a therapeutic colonoscopy afterwards. Our study showed a polyp prevalence (
10 mm) of 6%, almost comparable to that in screening populations (24). However, our results regarding participation in screening (91% would participate) cannot be extrapolated to a screening population, because the population that participated in our study is probably more aware of the importance of screening. Nevertheless, they do provide us with information about the limitations of MR colonography with limited bowel preparation.
Several limitations of our study must be considered. First, as in most research regarding acceptance of CT colonography and MR colonography, all MR colonography examinations were performed before the colonoscopy. It would have been preferable to randomize the order of procedures.
Second, when participants completed the questionnaires regarding preference, two facts were assumed—first, that the diagnostic value of MR colonography would be comparable to that of colonoscopy and second, that if participants preferred MR colonography for their next examination, 20% of participants would still have to undergo therapeutic colonoscopy after MR colonography. However, if polyps 10 mm or larger were considered to be clinically important, a considerably lower percentage of participants than the 20% mentioned in the questionnaire would actually be referred for colonoscopy. On the other hand, if the cutoff value for clinical importance was a size of 6 mm or greater, the assumed percentage of 20% would approximately correspond. Regarding diagnostic value, results for MR colonography are lower than for colonoscopy in the current study (sensitivity range, 58%–75%; specificity range, 93%–97% for participants with lesions
10 mm) (25). The two above-mentioned factors may have influenced the data. It seems plausible that a lower accuracy of MR colonography would probably favor colonoscopy, while lower referral rates would probably favor MR colonography.
Third, in our study, limited amounts of sedatives and analgesics were used during colonoscopy. Because some hospitals use larger doses and/or other sedatives and no bowel relaxants during MR colonography or CT colonography, participants' opinion about the burden and pain of colonoscopy may differ. This difference in the use of sedatives has frequently been quoted to explain different results in studies of patient acceptance of CT colonography (10). However, in our study, no statistically significant differences in preference were found between participants who received no analgesics and sedation and participants who received both. Both groups favored MR colonography with limited bowel preparation. These results are in line with those of the study performed by van Gelder et al (10), who state in their article that participants who do not request medication possibly have a more favorable view of colonoscopy. Like the use of sedatives, the amount and type of bowel preparation prescribed for colonoscopy may vary and may influence results regarding experience and preference.
Last, participants with claustrophobia were underrepresented in our study because they either did not participate in advance or dropped out during MR colonography. To our knowledge, only one participant with claustrophobia was able to undergo MR colonography.
In conclusion, we found that men and women at increased risk for colorectal cancer preferred MR colonography with limited bowel preparation to colonoscopy with standard bowel preparation, both immediately after the examinations and 5 weeks later. Although these results are promising, we believe acceptance can be improved if the burden of MR colonography could be reduced even more by, for example, using air for colonic distention and using faster imaging techniques to shorten acquisition times. If the diagnostic value of MR colonography suffices, implementation of MR colonography for surveillance or screening may contribute to high attendance rates.
| ADVANCES IN KNOWLEDGE |
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| IMPLICATION FOR PATIENT CARE |
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| ACKNOWLEDGMENTS |
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| FOOTNOTES |
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Authors stated no financial relationship to disclose.
| References |
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