Received: 11 January 2006 / Accepted: 13 February 2006 / Published online: 30 March 2007
§C Springer Science+Business Media, Inc. 2007
Abstract The aim of the present study was to determine if calcium polycarbophil ameliorates diarrhea after ileal J-pouch anal anastomosis for ulcerative colitis. Twenty- one randomized patients were given either bifidobacterium (3 g/day) plus calcium polycarbophil (3 g/day), in the poly- carbophil group (11 patients), or bifidobacterium (3 g/day), in the control group (10 patients), p.o. for 6 months. Anal manometry was performed and bowel function (stool fre- quency, stool consistency, and nighttime soiling) was as- sessed via a questionnaire before and 1, 3, and 6 months after drug administration. Eight patients were deemed eligi- ble in each group; five patients were excluded from the study, including two patients whose stool consistency was too firm and who experienced difficulty in defecating attributed to polycarbophil. Anal manometry and stool consistency did not change with time and did not differ between the poly- carbophil and the control groups. Stool frequency decreased with time in both groups and did not differ between the groups. Nighttime soiling improved with time in the poly- carbophil group but did not change in the control subjects. These results suggest that polycarbophil might be able to improve nighttime soiling without obviously affecting stool frequency and consistency after ileal J-pouch anal anasto- mosis for ulcerative colitis.
Keywords Calcium polycarbophil . Diarrhea . Ileal J-pouch anal anastomosis . Ulcerative colitis
C. Shibata ( ) Y. Funayama K. Fukushima K.-I. Takahashi
H. Ogawa S. Haneda K. Watanabe K. Kudoh A. Kohyama K.-I. Hayashi I. Sasaki
Division of Biological Regulation and Oncology, Department of Surgery, Tohoku University Graduate School of Medicine,
1–1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan e-mail: firstname.lastname@example.org
Proctocolectomy with ileal J-pouch anal anastomosis (IPAA) is an accepted surgical procedure for treating ulcerative colitis (UC) and familial adenomatous polyposis. Although post-IPAA diarrhea ameliorates after time, it may become in- tractable, causing fecal incontinence and reducing the quality of life (QOL). Loperamide (12 mg/day) is the most widely used antidiarrheic agent and was effective for post-IPAA diarrhea [1, 2]. However, in Japan the normal dose of lop- eramide is restricted to less than 2 mg/day, and thus it is often ineffective.
Calcium polycarbophil (CP) is believed to be effective in patients with either the diarrheic or the constipated type of irritable bowel syndrome [3, 4]. CP is an insoluble high molecular weight hydrophilic polymer which can absorb ap- proximately 70 times its original weight in water . Al- though this drug functions as a bulk laxative or as an antidiar- rheal agent depending on the intraluminal environment, CP does not prevent phentolphthalein-induced diarrhea [5, 6]. The aim of this randomized controlled trial was to determine if CP ameliorates post-IPAA diarrhea in patients with UC.
Patients. This study was approved by the institutional com- mittee on ethics in clinical trials. Twenty-one patients with UC who underwent proctocolectomy and IPAA in two- or three-stage operations were enrolled in this study. Patients with ileal J-pouch anal canal anastomosis were excluded from the study. Patients were recruited within 1 month after ileostomy closure and following informed consent. Patients taking antidiarrheic agents were excluded from the study.
Surgical procedures. Proctocolectomy was performed with rectal mucosectomy and a hand-sewn IPAA in
two- or three-stage operations. Three-stage operations were performed on patients requiring emergency surgery due to colitis or uncontrolled bleeding. Two-stage operations were performed on patients undergoing elective surgery. In the first stage of three-stage operations, patients underwent subto- tal colectomy with construction of a rectal mucous fistula and end-ileostomy. After several months, a second opera- tion was performed; after performing transanal rectal mu- cosectomy, we carried out transabdominal resection of the remnant rectum and creation of an ileal-J pouch. Subse- quently, a transanal IPAA was performed manually and a loop ileostomy was created 40–50 cm oral to the pouch. In two-stage operations, the first and second stages of the three-stage procedure were performed as an initial surgery. Finally, the loop ileostomy was excised and closed with a side-to-side ileo-ileostomy.
Methods. The patients were randomized into two groups, the CP and the control groups, using an envelope method. Bifidobacterium (3 g/day) plus CP (3 g/day; Polyful; Abbott, Japan, Co., Ltd.) was administered to the patients in the CP group (11 patients), whereas the control group (10 patients) received bifidobacterium alone (3 g/day) for 6 consecutive months. Anal manometry was performed and functional out- comes were assessed using a questionnaire. Anal manometry was performed using a non-perfusion-type microtransducer (MMS Co., Tokyo) before and 1 and 6 months after drug administration A catheter was introduced into the J-pouch in the left decubitis position, pulled automatically at a speed of 6 cm/min, and the maximal resting pressure (MRP) of the anus was measured. A questionnaire pertaining to bowel function was given to each patient before and 1, 3, and 6 months after the start of drug administration. Patients were requested to record total stool frequency per day, stool con- sistency, and frequency of nighttime soiling. Stool consis- tency was scored as follows: solid stool, 4 points; semisolid, 3 points; semiliquid, 2 points; and liquid, 1 point. The fre- quency of nighttime soiling was scored as follows: never, 5 points; two or three times a month, 4 points; once a week, 3 points; two or three times a week, 2 points; and every day, 1 point. Therefore, a higher score correlates with a better therapeutic response.
Statistical analysis. Wilcoxon signed-ranks test was used for comparisons within the same group, whereas the Mann- Whitney U test was used for comparisons across the two groups. P values <0.05 were regarded as significant. All values are expressed as mean ± SE.