Patients' perceptions of their participation in a clinical trial for postoperative Crohn's disease.

OBJECTIVE: To explore patients' perceptions of their participation in a randomized controlled trial. PATIENTS AND METHODS: A 27-item questionnaire was mailed to all patients who participated in a randomized controlled trial that determined the effectiveness of mesalamine in preventing the recurrence of Crohn's disease postoperatively. RESULTS: The response rate was 66% (99 of 149). Fifty-five per cent of the patients felt that they received better medical care than they otherwise would have and 53% liked taking the medication. Sixty-eight per cent of the patients did not feel that annual colonoscopy was too frequent and 81% felt that the time commitment did not significantly interfere with their job or other activities. Seventy-five per cent and 62% of the patients would have liked more information and education, respectively, about Crohn's disease incorporated into the trial. Although 91% of the patients would agree to participate in a future randomized controlled trial comparing medical therapies, only 44% would agree to participate in a future randomized controlled trial comparing medical with surgical therapies. CONCLUSIONS: The majority of patients were satisfied with their participation in the trial. A large proportion of the patients would participate again but would like more information and education incorporated into the trial. Furthermore, post-trial questionnaires may be helpful in the design of future trials.

A patient with localized megacolon and intractable constipation: evidence for impairment of colonic muscle tone.

There have been descriptions of a variety of abnormalities in motor function in patients with megacolon; however, colonic tone in megacolon has not been measured to date. Recent data suggest that colonic hypertonicity of carcinoid diarrhea is measurable with an electronic barostat. Using a barostat method, we have evaluated colonic transit, motility, and tone in a patient with severe constipation and localized chronic megacolon. Transit measurements showed a significant delay beyond the mid transverse colon; motility studies in the dilated region of colon showed abnormally low tone but normal phasic contractility, as measured by the barostat. In contrast, manometry showed low amplitude contractions relative to control data; this discrepancy probably results from the large capacity of the segment of colon examined. Chronic megacolon can be associated with abnormal colonic tone, which can be measured by means of an electronic barostat.

Quantification of the fate of dietary fiber in humans by a newly developed radiolabeled fiber marker.

A radiolabeled cellulose (131I-fiber) that retains the essential physical and chemical properties of this class of fiber was developed in our laboratory. We quantified the fate of orally ingested 131I-fiber in healthy individuals by external gamma camera monitoring and fecal collections. The marker passes virtually intact through the human gastrointestinal tract with negligible release and absorption of the label in the gut. Comparison of the gastric emptying rate of 131I-fiber with that of a predominantly aqueous marker, 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA), showed that 131I-fiber strands were evacuated more slowly than intragastric fluids. An important finding was that some 131I-fiber emptying occurred during most time periods, even before liquids were completely evacuated. This suggests that the human stomach is able to empty simultaneously liquids and fiber strands (1-15 mm in length) that are resistant to grinding by antral mechanical forces and to digestion by acid-peptic secretion. Thus, some nondigestible solids may be emptied with the bulk of a meal, although at a slower rate. 131I-Fiber may be a useful marker for quantifying gastric emptying of nondigestible solids. Further, the stability of 131I-fiber in the gut, as opposed to most other physiologic solid labels, should enable future investigation of intestinal and colonic transit of fiber, which is an important component of the human diet.

Mesenteric fibromatosis complicating familial adenomatous polyposis: predisposing factors and results of treatment.

Between January 1975 and December 1983, 24 of 183 patients (13%) with familial adenomatous polyposis (FAP) seen at the Mayo Clinic had mesenteric fibromatosis (MF). MF was found most often in FAP patients with associated extra-colonic "Gardner" signs (19 patients) and those who had had previous abdominal surgery (20 patients). In 4 patients, MF appeared spontaneously. The male-to-female ratio was 0.4, with a median age of 31 years in women and 37 years in men. Ten of 24 patients (42%) had been asymptomatic prior to diagnosis at time of surgery for FAP. Complications of the disease included intestinal or urinary tract obstruction. Minimal surgical manipulation seemed to be associated with fewer postoperative complications and a lesser risk of regrowth of the tumor. Nonsurgical treatment, including tamoxifen and sulindac in combination, may be beneficial. Surgery should be reserved for relief of obstruction, and bypass is preferred to resection.

Intestinal transit of solid and liquid components of a meal in health.

The aim of this study was to test the hypothesis that, under physiologic conditions, the human small bowel discriminates between the solid and aqueous components of chyme, that is, that in a fashion analogous to the stomach, the intestine would allow the liquid fraction to progress at a faster rate than solid particles. To evaluate this hypothesis, we took advantage of a gamma-emitting solid marker, 131I-fiber, previously developed in our laboratory, that is recognized by the stomach as a solid and that is emptied at a slower rate than liquid markers. Thus, 131I-fiber enters the intestine during feeding at a slower rate than a liquid marker, being eventually excreted in the feces physically and chemically unchanged. We also developed a mathematical method to calculate the intestinal transit spectrum based on scintigraphic data obtained from 6 healthy individuals who ingested 131I-fiber and technetium 99m (99mTc)-diethylenetriaminepentaacetic acid (DTPA)-water with a meal. The results disprove the hypothesis by showing that whereas 131I-fiber, as expected, leaves the stomach at a much slower rate than 99mTc-DTPA-water, both markers progress along the small bowel separately but at similar speeds. Our method for measuring intestinal transit provides a more comprehensive quantification of chyme transit in the human small bowel than earlier methods and should prove a useful technique for further noninvasive studies of transit after feeding.

Prophylactic mesalamine treatment decreases postoperative recurrence of Crohn's disease.

BACKGROUND & AIMS: Recurrence of Crohn's disease frequently occurs after surgery. A randomized controlled trial was performed to determine if mesalamine is effective in decreasing the risk of recurrent Crohn's disease after surgical resection is performed. METHODS: One hundred sixty-three patients who underwent a surgical resection and had no evidence of residual disease were randomized to a treatment group (1.5 g mesalamine twice a day) or a placebo control group within 8 weeks of surgery. The follow-up period was a maximum of 72 months. RESULTS: The symptomatic recurrence rate (symptoms plus endoscopic and/or radiological confirmation of disease) in the treatment group was 31% (27 of 87) compared with 41% (31 of 76) in the control group (P = 0.031). The relative risk of developing recurrent disease was 0.628 (90% confidence interval, 0.40-0.97) for those in the treatment group (P = 0.039; one-tail test) using an intention-to-treat analysis and 0.532 (90% confidence interval, 0.32-0.87) using an efficacy analysis. The endoscopic and radiological rate of recurrence was also significantly decreased with relative risks of 0.654 (90% confidence interval, 0.47-0.91) in the effectiveness analysis and 0.635 (90% confidence interval, 0.44-0.91) in the efficacy analysis. There was only one serious side effect (pancreatitis) in subjects in the treatment group. CONCLUSIONS: Mesalamine (3.0 g/day) is effective in decreasing the risk of recurrence of Crohn's disease after surgical resection is performed.

Risk and significance of endoscopic/radiological evidence of recurrent Crohn's disease.

BACKGROUND & AIMS: The aim of this study was to determine the risk of endoscopic/radiological recurrence of Crohn's disease postoperatively and the long-term outcome. METHODS: A randomized placebo-controlled trial was performed to determine the effectiveness of mesalamine in preventing recurrent Crohn's disease postoperatively. Patients in the control group were examined endoscopically/radiologically before entry into and annually during the trial. Findings were classified as minimal or severe. RESULTS: There were 76 patients (49 men and 37 women; mean age, 37.1 +/- 13.2 years). Fifty (61.7%) had terminal ileal resections. Overall, 55 endoscopic/radiological recurrences were observed in 51 patients (67.1%). Expressed actuarially, the recurrence rate was 27.5% at 1 year (95% confidence interval [CI], 15.8%-37.6%), 60.8% at 2 years (95% CI, 46%-71.3%), and 77.3% at 3 years (95% CI, 62.7%-86.3%). Nineteen (37%) were symptomatic and 12 (24%) were initially asymptomatic but later became symptomatic (mean, 13.0 +/- 8.8 months), whereas 20 (39%) remained asymptomatic (mean, 16.9 +/- 17.4 months). Patients with severe endoscopic/radiological disease were significantly more likely to be or become symptomatic than those with minimal disease (23 of 32 vs. 8 of 19, respectively; P = 0.0437). CONCLUSIONS: This study suggests that postoperative endoscopic/radiological recurrences occur later than previously reported. Furthermore, many of these patients, especially with minimal disease, will remain asymptomatic.