Does limited placement of bioresorbable membrane of modified sodium hyaluronate and carboxymethylcellulose (Seprafilm) have possible short-term beneficial impact?

PURPOSE: The aim of the study was to assess the impact of sodium hyaluronate and carboxymethylcellulose membrane (Seprafilm) on postoperative intestinal obstruction as judged by the rates of bowel obstruction and laparotomy for bowel obstruction. A secondary aim was to assess early postoperative morbidity. METHODS: All patients who had Seprafilm placed during colorectal surgery between June 1993 and October 1998 were included in the study group and compared with a matched group of patients without Seprafilm. All patients were assessed for intestinal obstruction and complications by telephone interview and chart review. Statistical tests for independence were used where appropriate; alpha was 0.05 for all tests, and the two groups were tested for case matching. Fisher's exact test was used to compare gender distribution, nature of diagnosis (inflammatory vs. noninflammatory), and urgency of surgery (elective vs. emergency). The age distribution, number of prior abdominal surgeries, and operative time were compared by Student's t-test. Approximation of Katz test was used for independent proportions to compare the two groups for early postoperative morbidity and overall incidence of intestinal obstruction and surgical enterolysis. The incidence of intestinal obstruction between the two groups was also compared with Kaplan-Meier product limit method and log-rank test. RESULTS: Two hundred fifty-nine patients in whom Seprafilm was placed were compared with a well-matched control cohort of 179 patients. The two groups did not differ in gender or age. One-half of each group had inflammatory conditions, and approximately 90 percent of each group underwent elective operations. The operative times were similar. Both groups had a similar number of abdominal operations before inclusion (mean = 1.2, both groups). Early morbidity rates were 17.8 percent for the Seprafilm group and 15.6 percent for the controls, with mortality rates of 0.8 percent and 0.0 percent, respectively. There were 12 intestinal obstructions in 12 patients in the Seprafilm group and 12 intestinal obstructions in 11 patients in the control group at a follow-up period of 65 months in the Seprafilm group and 81 months in the control group. Eight of the 12 intestinal obstructions in the Seprafilm group resolved with conservative management while only 5 of 12 in the control group responded without surgery. Thus the enterolysis rate was 1.5 percent in the Seprafilm group and 3.9 percent in the control group, demonstrating a trend in favor of Seprafilm. There were no statistically significant differences in the incidence of either overall or abdominopelvic septic complications between the Seprafilm (3.4 percent) and control (1.1 percent) groups. CONCLUSION: During short-term follow-up in this nonprospective, nonrandomized study, limited placement of Seprafilm did not significantly reduce the need for surgical enterolysis for intestinal obstruction or significantly adversely affect the morbidity rate. However, a long-term, prospective, randomized trial is underway to elucidate these issues.

Outcome and management of patients with large rectoanal intussusception.

OBJECTIVES: Rectoanal intussusception is the funnel-shaped infolding of the rectum, which occurs during evacuation. The aims of this study were to evaluate the risk of full thickness rectal prolapse during follow-up of patients with large rectoanal intussusception, and whether therapy improved functional outcome. METHODS: Between September 1988 and July 1997, patients diagnosed with a large rectoanal intussusception by cinedefecography (intussusception > or = 10 mm, extending into the anal canal) were retrospectively evaluated. Patients with full thickness rectal prolapse on physical examination or cinedefecography were excluded, as were patients with colonic inertia or a history of surgery for rectal prolapse. The patients were divided into three groups according to the treatment received: group I, conservative dietary therapy; group II, biofeedback; and group III, surgery. Outcomes were obtained by postal questionnaires or telephone interviews. Parameters included age, gender, past medical and surgical history, change of bowel habits, fecal incontinence score, and development of full thickness rectal prolapse. RESULTS: Of the 63 patients, 18 were excluded (seven patients had confirmed full thickness rectal prolapse, four had previous surgery for rectal prolapse, three had colonic inertia, and four died). Follow-up data were obtained in 36 (80%) of the remaining 45 patients. The mean follow-up of this group was 45 months (range, 12-118 months). There were 34 women and two men, with a mean age of 72.4 yr (range, 37-91 yr). The mean size of the intussusception was 2.2 cm (range, 1.0-5.0 cm). The patients were classified as follows: group I, 13 patients (36.1%); group II, 13 patients (36.1%); and group III, 10 patients (27.8%). Subjectively, symptoms improved in five (38.5%), four (30.8%), and six (60.0%) patients in the three groups (p > 0.05). Among the patients with constipation, the decrease in numbers of assisted bowel movements per week (time of diagnosis to present) was significantly greater in group II compared to group 1 (8.1+/-2.8 vs 0.8+/-0.5, respectively, p = 0.004). Among the patients with incontinence, incontinence scores improved more in group II as compared to either group I or group III (time of diagnosis to present, 3.7+/-4.2 to 1.1+/-5.4 vs 1.4+/-2.2, respectively, p > 0.05). Six patients (two in group I, three in group II, and one in group III) had the sensation of rectal prolapse on evacuation; however, only one patient in group I developed full thickness rectal prolapse. CONCLUSIONS: This study demonstrated that the risk of full thickness rectal prolapse developing in patients medically treated for large intussusception is very small (1/26, 3.8%). Moreover, biofeedback is beneficial to improve the symptoms of both constipation and incontinence in these patients. Therefore, biofeedback should be considered as the initial therapy of choice for large rectoanal intussusception.

Intraobserver and interobserver measurements of the anorectal angle and perineal descent in defecography.

PURPOSE: Anorectal angle and perineal descent can be measured either by drawing a line defined by the impression of the puborectalis muscle and the tangential of the posterior rectal wall (Method A) or by drawing a straight line at the level of the posterior rectal wall parallel to the central longitudinal axis of the rectum (Method B). The aim of this study was to assess the reproducibility of measuring anorectal angle and perineal descent by two different methods according to intraobserver and interobserver measurement and to evaluate which method yields more consistent results. METHODS: Five physicians who have had an average of 1.3 years (range, 6 months to 1.5 years) experience in defecographic measurement drew both lines on 63 randomly selected defecographic films and measured anorectal angle and perineal descent by the two methods. The defecographic parameters were measured twice by each observer during a three-week interval. To avoid potential bias, one physician who did not participate in either measurement of perineal descent or anorectal angle performed all data collection. Intraobserver and interobserver agreement was quantified using Shrout and Fleiss intraclass correlation coefficients. RESULTS: The mean and range of intraclass correlation coefficients for intraobserver agreement of measuring anorectal angle and perineal descent by Method A were 0.71 (0.6-0.78) and 0.89 (0.74-0.97), respectively, whereas with Method B the coefficients were 0.81 (0.73-0.89) and 0.93 (0.89-0.99), respectively. Regarding the interobserver agreement of the five observers, the mean coefficients for measurement of both anorectal angle and perineal descent by both methods showed similar agreement levels (0.88 and 0.98 by Method A and 0.89 and 0.97 by Method B). The mean (+/- standard deviation) values of anorectal angle and perineal descent found by Method B were significantly larger than those found by Method A (103.3 degrees +/- 19.6 and 6.56+/-3.20 cm and 91.1 degrees +/- 25.6 and 5.64+/-3.42 cm, respectively; P<0.001). CONCLUSION: Intraobserver and interobserver intraclass correlation coefficients of anorectal angle and perineal descent, which were measured by both methods, were more than 0.60, indicating that both methods are reliable and consistent for measurement of anorectal angle and perineal descent. However, centers should consistently use the same line for measurement of anorectal angle and perineal descent because of the statistically significant differences between the two methods and the possibility of inconsistent results.