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Aim: Whether smoking affects disease distribution, phenotype, and perioperative outcomes for Crohn's disease (CD) patients undergoing surgery is not well characterized. The aim of this study is to evaluate the impact of smoking on disease phenotype and postoperative outcomes for CD patients undergoing surgery, Methods: Prospectively collected data of CD patients undergoing colorectal resection were evaluated. CD patients who were current smokers (CS) were compared to nonsmokers (NS) and ex-smokers (ES) for disease phenotype, anatomic site involved, procedures performed, postoperative outcomes, and quality of life using the Cleveland Global Quality of Life instrument (CGQL)., Results: Of 691 patients with a diagnosis of CD requiring surgery 314 were classified as CS, 330 as NS, and 47 as ES. CS and ES in comparison to NS were significantly older at diagnosis of Crohn's disease (mean, 29.3 vs. 29.2 vs. 26.3 years) (P = 0.001) and older at the time of primary surgery (mean, 42.9 vs. 48.4 vs. 39 years) (P = 0.001) with a greater frequency of diabetes. In all groups requiring surgery, there was a significant change in disease phenotype from the time of diagnosis to surgical intervention. The predominant phenotype at diagnosis was inflammatory which changed to stricturing and penetrating as the dominant phenotypes at time of surgery. All groups had a significant improvement in CGQL scores post-surgery with the greatest benefit observed in NS. Postoperative complications and 30-day readmission rates were similar between all groups., Conclusions: The findings of this study show that in patients with CD, disease phenotype changes over time. This occurs independent of smoking. Smoking does not appear to predispose to complications for CD patients undergoing surgery. CS and ES have a persistently reduced quality of life in comparison to NS post-surgery.

Background & Aims: There has been controversy over the significance of active inflammation of the terminal ileum (also known as backwash ileitis) in patients with ulcerative colitis (UC) and idiopathic inflammatory bowel disease of indeterminate type for diagnosis and pouch construction. We investigated the impact of backwash ileitis on pouch outcome after restorative proctocolectomy with ileoanal pouch anastomosis., Methods: Data from patients with backwash ileitis (n = 132) were compared with those from 132 matched controls without ileal inflammation for age, sex, and type of proctocolectomies with ileal pouch construction (1- or 2-stage). We evaluated terminal ileal sections from original colectomies of 2213 patients with either UC or idiopathic inflammatory bowel disease of indeterminate type, collected during a 21-year period, for extent and severity of chronic and active ileitis. Clinical pouch outcomes were assessed through a longitudinally maintained clinical outcome database that systematically catalogued all short-term and long-term pouch complications, including pouchitis, sepsis, impaired long-term pouch survival, and conversion to Crohn's disease., Results: Regardless of severity or extent, backwash ileitis was not correlated with any clinical outcome examined, short-term or long-term., Conclusions: Ileal inflammation is not a contraindication for restorative proctocolectomy with ileal pouch construction in patients with UC or idiopathic inflammatory bowel disease of indeterminate type. Ileal inflammation with pancolitis is not a useful criterion for classifying otherwise typical UC as colitis of indeterminate type, because pouch outcomes are not affected., (Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) has substantially reduced the risk for ulcerative colitis (UC)-associated dysplasia or cancer (neoplasia). We characterized features, risk factors, and outcomes of pouch neoplasia in patients with inflammatory bowel disease in a historical cohort study., Methods: A total of 3203 patients with a preoperative diagnosis of inflammatory bowel disease underwent restorative proctocolectomy with IPAA from 1984 to 2009 at the Cleveland Clinic. Demographic, clinical, and endoscopic data were reviewed and samples were examined by histological analyses. Univariable and Cox regression analyses were performed., Results: Cumulative incidences for pouch neoplasia at 5, 10, 15, 20, and 25 years were 0.9%, 1.3%, 1.9%, 4.2%, and 5.1%, respectively. Thirty-eight patients (1.19%) had pouch neoplasia, including 11 (0.36%) with adenocarcinoma of the pouch and/or the anal-transitional zone (ATZ), 1 (0.03%) with pouch lymphoma, 3 with squamous cell cancer of the ATZ, and 23 with dysplasia (0.72%). In the Cox model, the risk factor associated with pouch neoplasia was a preoperative diagnosis of UC-associated cancer or dysplasia, with adjusted hazard ratios of 13.43 (95% confidence interval: 3.96-45.53; P < .001) and 3.62 (95% confidence interval: 1.59-8.23; P = .002), respectively. Mucosectomy did not protect against pouch neoplasia., Conclusions: Risk for neoplasia in patients with UC and IPAA is small and not eliminated by colectomy or mucosectomy. A preoperative diagnosis of dysplasia or cancer of colon or rectum is a risk factor for pouch dysplasia or adenocarcinoma., (Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Diagnosis and management of chronic antibiotic-refractory pouchitis and Crohn's disease of the pouch can be challenging. Pyloric gland metaplasia is a histological feature indicative of chronic mucosal inflammation. Its value in diagnosis and prognosis of pouch disorders has not been investigated., Aim: To assess the prevalence, diagnostic and prognostic value, and risk factors of pyloric gland metaplasia in pouch patients., Methods: Patients were identified from our prospectively maintained Pouchitis Database. Pouch biopsy specimens were re-reviewed for pyloric gland metaplasia and other histological features. Two cohorts of patients were studied: a historical cohort (n = 111) and the second, a validation cohort (n = 100). Univariate and multivariate analyses were performed to assess risk factors for pyloric gland metaplasia., Results: The prevalence of pyloric gland metaplasia in the historical cohort and validation cohort was 45 (40.1%) and 24 (24.0%), respectively. The sensitivity and specificity of pyloric gland metaplasia for the diagnosis of chronic antibiotic-refractory pouchitis or Crohn's disease were 70.7% and 92.5%, respectively, for the first cohort and 39.0% and 86.4%, respectively, for the 2nd validation cohort. In multivariate analysis of the first cohort, patients with refractory pouchitis or Crohn's disease were 28 times (95% CI, 7.3-107.1) more likely to have pyloric gland metaplasia than those with a normal pouch or irritable pouch syndrome. The factor of refractory pouchitis or Crohn's disease remained in the model for the 2nd validation cohort with odds ratio of 4.58 (95% CI, 1.6-13.4)., Conclusions: Pyloric gland metaplasia is associated with diagnosis of chronic antibiotic-refractory pouchitis or Crohn's disease of the pouch and appears to be a specific marker for both disease entities.

Background: Crohn's disease (CD) of the pouch can develop in patients with ileal pouch-anal anastomosis (IPAA). Scant data are available on the treatment of this disease entity., Aim: To evaluate efficacy and safety of adalimumab in treating CD of the ileal pouch., Methods: From June 2007 to June 2008, 17 IPAA patients with inflammatory (n = 10), fibrostenotic (n = 2) or fistulizing (n = 5) CD of the pouch treated with adalimumab were evaluated. Inclusion criteria were CD of the pouch who failed medical therapy and were otherwise qualified for permanent pouch diversion or excision. All qualified patients received the standard dosing regimen of subcutaneous injection adalimumab (160 mg at week 0, 80 mg at week 1, and 40 mg every other week thereafter). Complete clinical response was defined as resolution of symptoms. Partial clinical response was defined as improvement in symptoms. Endoscopic inflammation before and after therapy was recorded, using the Pouchitis Disease Activity Index (PDAI) endoscopy subscores., Results: The median age was 36 years with 12 patients (70.6%) being male. At 4 weeks, seven patients (41.2%) had a complete symptom response and 6 (35.3%) had a partial response. There was also a significant improvement in the PDAI endoscopy subscores at week 4 (P < 0.05). At the last follow-up (median of 8 weeks), eight patients (47.1%) had a complete symptom response and 4 (23.5%) had a partial response. Four patients (23.6%) developed adverse effects. Three patients (17.7%) eventually had pouch failure after failing to respond to adalimumab therapy., Conclusion: Adalimumab appeared to be well-tolerated and efficacious in treating CD of the pouch in this open-labelled induction study.

Restorative proctocolectomy with ileal pouchanal anastomosis (IPAA) is the surgical treatment of choice for complicated ulcerative colitis. Development of ileal pouch-related cancer is a rare event and usually occurs in association with backwash ileitis or chronic pouchitis. We report a case of adenocarcinoma at the inlet of an ileal pouch in a 68-year-old Caucasian male, 14 years after restorative proctocolectomy for ulcerative colitis in the absence of severe chronic pouchitis or backwash ileitis. The operative technique is described, with a review of the literature on ileal pouch cancer.

Background & Aims: There has been an increase in the incidence and severity of Clostridium difficile-associated diarrhea in the U.S. The importance of C difficile infection in patients with ileal pouch-anal anastomosis (IPAA) is unknown. This study was designed to determine risk of acquiring C difficile infection in pouch disorders., Methods: Consecutive ulcerative colitis patients (n = 115) with IPAA undergoing pouch endoscopy were enrolled from May 2005-March 2006. Fecal specimens of pouch aspirate were collected during pouch endoscopy and analyzed for C difficile toxin A and B by enzyme-linked immunosorbent assay. Nineteen clinical, endoscopic, and histologic variables were assessed with stepwise selection methods. Two multivariate logistic regression models were constructed., Results: Twenty-one patients (18.3%) were positive for C difficile infection. Adjusting for other factors in the model, men were 5.12 (95% confidence interval, 1.38-20.46) times more likely to have C difficile infection than women. Compared with patients with pancolitis, those with preoperative left-sided colitis were 8.4 (95% confidence interval, 1.25-56.4) times more likely to have C difficile infection. Six of 6 patients with C difficile infection (3 with refractory pouchitis, 2 with Crohn's disease, and 1 with irritable pouch syndrome) with repeat clinical, endoscopic, and laboratory evaluation after anti-C difficile therapy experienced clinical remission and disappearance of C difficile toxin from stools, with 4 showing decreased mucosal inflammation., Conclusions: C difficile infection involving IPAA is common, characteristically occurring with or without previous receipt of antibiotics. Treatment of C difficile infection in patients with IPAA might improve the clinical outcome.

Both medical and surgical therapies for ulcerative colitis have inherent advantages and disadvantages that must be balanced for patients with moderate to severe disease. Restorative proctocolectomy with ileal pouch-anal anastomosis has become the surgical treatment of choice for the majority of patients with ulcerative colitis who require proctocolectomy. However, adverse sequelae of mechanical, inflammatory, functional, neoplastic, and metabolic conditions related to the pouch can occur postoperatively. Recognition and familiarization of the disease conditions related to the ileal pouch can be challenging for practicing gastroenterologists. Accurate diagnosis and classification of the disease conditions are imperative for proper management and prognosis.

Background & Aims: The effect of orthotopic liver transplantation (OLT) for primary sclerosing cholangitis (PSC) and post-OLT immunosuppression on the disease course of pouchitis is not clear. The aims of this study were to compare the frequency of chronic antibiotic-refractory pouchitis (CARP) in PSC patients with or without OLT and to assess potential risk factors for CARP in these patients., Methods: Ulcerative colitis patients with PSC and ileal pouch-anal anastomosis (IPAA) with or without OLT identified from our prospectively maintained pouch database were analyzed. CARP was diagnosed based on persistent symptomatic pouchitis after a 4-week single- or dual-antibiotic therapy., Results: A total of 63 PSC/IPAA patients were studied, including 19 patients with OLT and 44 patients without OLT. Fifty patients (79.4%) had CARP. In both univariable and multivariable analyses (adjusting for OLT status), none of the variables studied was associated significantly with CARP (P > .20). All 7 patients (100%) with IPAA-then-OLT were diagnosed as having CARP, of whom 4 developed CARP before OLT, which persisted after OLT, and 3 had CARP after OLT. Of 12 patients with OLT-then-IPAA, 7 (58.3%) developed CARP. The frequency of CARP in OLT-then-IPAA was statistically significantly lower than that in IPAA-then-OLT (58.3% vs 100%; P = .047)., Conclusions: CARP is common in patients with ulcerative colitis and PSC. OLT in these patients may not affect the frequency of CARP in general and appears not to alter the disease course of pre-existing CARP. However, in a subset of patients, OLT might reduce the risk for the development of de novo CARP.

Introduction: Colonic pouches have been used for 20 years to provide reservoir function after reconstructive proctectomy for rectal cancer. More recently coloplasty has been advocated as an alternative to a colonic pouch. However there have been no long-term randomized, controlled trials to compare functional outcomes of coloplasty, colonic J-Pouch (JP), or a straight anastomosis (SA) after the treatment of low rectal cancer., Aim: : To compare the complications, long-term functional outcome, and quality of life (QOL) of patients undergoing a coloplasty, JP, or an SA in reconstruction of the lower gastrointestinal tract after proctectomy for low rectal cancer., Methods: A multicenter study enrolled patients with low rectal cancer, who were randomized intraoperatively to coloplasty (CP-1) or SA if JP was not feasible, or JP or coloplasty (CP-2) if a JP was feasible. Patients were followed for 24 months with SF-36 surveys to evaluate the QOL. Bowel function was measured quantitatively and using Fecal Incontinence Severity Index (FISI). Urinary function and sexual function were also assessed., Results: Three hundred sixty-four patients were randomized. All patients were evaluated for complications and recurrence. Mean age was 60 +/-12 years, 71% were male. Twenty-three (7.4%) died within 24 months of surgery. No significant difference was observed in the complications among the 4 groups. Two hundred ninety-seven of 364 were evaluated for functional outcome at 24 months. There was no difference in bowel function between the CP-1 and SA groups. JP patients had fewer bowel movements, less clustering, used fewer pads and had a lower FISI than the CP-2 group. Other parameters were not statistically different. QOL scores at 24 months were similar for each of the 4 groups., Conclusions: In patients undergoing a restorative resection for low rectal cancer, a colonic JP offers significant advantages in function over an SA or a coloplasty. In patients who cannot have a pouch, coloplasty seems not to improve the bowel function of patients over that with an SA.

Objectives: Prophylactic insertion of ureteric stents aids intra-operative identification of ureters and may allow easier visualization of any direct ureteric injury. Traditionally, ureteric catheters are inserted sequentially, before starting the abdominal part of the operation. This study determines the safety and efficacy of simultaneous intra-operative ureteric catheter insertion during complicated and re-operative colorectal surgery., Materials and Methods: After institutional review board (IRB) approval, 24 patients were randomized into two groups, sequential (SEQ) and simultaneous (SIM) depending upon the timing of stent placement relative to abdominal incision. Time taken from induction to abdominal incision (AIT), induction to peritoneal entry (PET), catheter insertion time (CIT), and urinary tract infection rates were recorded. Degree of difficulty for stent insertion was graded on a scale of 1-10., Result: Demographics were similar between groups. Mean AIT (22 +/- 4 vs 41 +/- 7; p = 0.0001) and mean PET (26 +/- 4.2 vs 44 +/- 7.6; p = 0.0001) were shorter in the SIM group. There was no significant difference in mean CIT in SIM and SEQ groups (17.9 +/- 4.9 vs 17.6 +/- 5.9 min, p = 0.8). The stents were unsuccessful bilaterally in one patient in the SEQ group and unilaterally in two other patients, one in each group. The median difficulty score for catheter insertion was 3 (1-10) and 2 (1-10), (p = 0.12), respectively, in SIM and SEQ groups. There were no ureteric injuries in either group. One patient in SIM developed a urinary tract infection., Conclusion: Simultaneous ureteric catheter insertion during abdominal procedures reduces operating times without a significant increase in morbidity. Furthermore, this permits a policy of selective stent insertion as required by the intra-abdominal findings after laparotomy.

Purpose: Chronic infection with schistosomiasis has been clearly associated with the development of bladder cancer, and infestation is associated with a high incidence of colorectal cancer in endemic populations. Despite this association, the potential role of alterations in tumor suppressor genes colorectal cancers has never been evaluated in an endemically infected population. The aim of this paper was to compare histopathologic and genetic changes in schistosomal colitis-associated colorectal cancer (SCC) with colorectal cancer in a group of patients from the same population not affected by the disease (NDCC)., Materials and Methods: Sixty patients were included in this study: SCC-40, NDCC-20. Data collected included age, sex, clinical presentation, presence of synchronous tumors, histopathology, and clinical stage. p53, DCC (deleted in colorectal cancer gene), and mismatch repair genes (MLH1 and MSH2) were studied using immunohistochemical staining., Results: Patients with SCC were significantly younger than the NDCC group (34.52+/-11.22 years vs 50.73+/-12.75 years, p=0.02). Mucinous adenocarcinoma occurred significantly more frequently in SCC (35 vs 10%, p=0.02). SCC tumors were more frequently stage III or IV, and significantly more synchronous tumors were present in the affected group (SCC-8/40 vs NDCC-1/20, p=0.05). p53 staining was far more frequent in SCC (SCC-32/40 vs NDCC-8/20, p=0.006). DCC expression was similar in two groups. There were only four cases, three in SCC and one in NDCC, that showed microsatellite instability., Conclusion: The data suggest that schistosomal colitis is more commonly associated with earlier onset of multicentric colorectal cancer, high percentage of mucinous adenocarcinoma, and presents at an advanced stage. The identification of a higher incidence of altered p53 expression in the SCC group raises the possibility of an association between schistosomiasis and alterations in p53 activation as an inciting event in colorectal cancer development.

Purpose: Measure the association between the incidence of primary tumor staining and the identification of mediastinal lymph node (MLN) using cytokeratins, NM23, DCC-positive tumors, and vascular endothelial growth factor (VEGF) expression in T(2) and T(3)/N(0) colorectal cancers. The impact of MLN on both recurrence and survival was assessed., Materials and Methods: There were 153 CORC patients (T(2), T(3)/N(0)) selected from a prospectively accrued database. All patients had been staged by routine histopathology after a curative resection and no patients received adjuvant chemotherapy. The primary tumors (PT) were assessed with a panel of immunohistochemical stains (cytokeratin, DCC, Nm23, and VEGF). If the PT was positive, the regional nodes were assessed with that marker(s). For any positive tumor marker, all lymph nodes (LNs, mean of 12.6+/-4.2) were stained for this marker., Results: Patient age ranged from 38 to 86 years with a mean age of 61.56+/-25.56 years. Mean follow-up was 72.1+/-32.4 months. Recurrence rate of the whole group was 19/153 (12.4%) and the mean time to recurrence was 37.6+/-23.6 months (15 to 77 months). Crude mortality was 39.9%, while the cancer specific mortality was 11.2% after the whole follow-up period. The relationship between PT staining and MLNs was: cytokeratin-PT 143 (93.5%)/MLN 9 (6.3%); NM23-PT 51 (33.3%)/MLN 3 (5.9%); DCC-PT 79 (53%)/MLN 3 (3.8%); and VEGF-PT 72 (47%)/MLN 4 (5.6%). Nineteen (12.4%) patients experienced tumor recurrence. No correlation exist between PT and/or MLN staining and either recurrence or survival. No patient with MLN with any stain experienced a recurrence. There was no advantage to using an individual stain or all four stains., Conclusion: Immunohistochemical stains for PT and focused analysis of regional nodes did not improve prediction of survival or recurrence. Sentinel LN evaluation and the provision of adjuvant chemotherapy in node-negative patients should be questioned and not be utilized outside of a research protocol.

Objective: To compare primary resection and anastomosis (PRA) with and without defunctioning stoma to Hartmann's procedure (HP) as the optimal operative strategy for patients presenting with Hinchey stage III-IV, perforated diverticulitis., Summary Background Data: The choice of operation for perforated diverticulitis lies between HP and PRA. Postoperative mortality and morbidity can be high, and the long-term consequences life-altering, with no established criteria guiding clinicians towards selecting a particular procedure., Methods: Probability estimates for 6879 patients with Hinchey III-IV perforated diverticulitis were obtained from two databases (n = 204), supplemented by expert opinion and summary data from 12 studies (n = 6675) published between 1980 and 2005. The primary outcome was quality-adjusted life-years (QALYs) gained from each strategy. Factors considered were the risk of permanent stoma, morbidity, and mortality from the primary or reversal operations. Decision analysis from the patient's perspective was used to calculate the optimal operative strategy and sensitivity analysis performed., Results: A total of 135 PRA, 126 primary anastomoses with defunctioning stoma (PADS), and 6619 Hartmann's procedures (HP) were considered. The probability of morbidity and mortality was 55% and 30% for PRA, 40% and 25% for PADS, and 35% and 20% for HP, respectively. Stomas remained permanent in 27% of HP and in 8% of PADS. Analysis revealed the optimal strategy to be PADS with 9.98 QALYs, compared with 9.44 QALYs after HP and 9.02 QALYs after PRA. Complications after PRA reduced patients QALYs to a baseline of 2.713. Patients with postoperative complications during both primary and reversal operations for PADS and HP had QALYs of 0.366 and 0.325, respectively. HP became the optimal strategy only when risk of complications after PRA and PADS reached 50% and 44%, respectively., Conclusion: Primary anastomosis with defunctioning stoma may be the optimal strategy for selected patients with diverticular peritonitis as may represent a good compromise between postoperative adverse events, long-term quality of life and risk of permanent stoma. HP may be reserved for patients with risk of complications >40% to 50% after consideration of long-term implications.

Background and Purpose: Assessment of risk factors associated with the use of perioperative allogeneic blood transfusion and the effect of transfusion on infectious complications after ileal pouch-anal anastomosis (IPAA)., Methods: All patients included had IPAA with ileostomy. They were divided into two groups: transfused (TRAN); nontransfused (NON). Data included age, gender, preoperative anemia (Hgb <9 l g/dl), operative blood loss, transfusion volume, incidence of postoperative infectious or anastomotic complications, and length of stay (LOS)., Results: The 1,202 patients eligible for the study were divided into: TRAN = 240 patients and NON = 962 patients. The patient age, sex, and preoperative steroid use were similar in both groups. Significantly, more patients in the TRAN group were anemic preoperatively (32 vs 11%; p<0.05) and the preoperative Hgb level was significantly lower in the TRAN (12.07; p<0.05 vs 13.34 g/dl). Transfusion was required more frequently in anemic patients (p<0.001). The overall infection rate was significantly higher in the TRAN (48.75 vs 11.22%, p<0.001), Anastomotic separation (10.83 vs 3.32%, TRAN and NON, respectively; p<0.001) and fistula formation percentage (20.8 vs 4.46%, TRAN and NON, respectively; p<0.001) was significantly higher in the TRAN group. Pelvic sepsis also occurred more frequent in TRAN (22.9 vs 4.2%, TRAN and NON, respectively; p<0.001). The incidence of any infectious complication at any site was higher in anemic patients irrespective of transfusion status (18.2 vs 2.8%, p<0.05). Transfusion was the only significant independent risk factor for postoperative infections. LOS was adversely affected by an infectious complication (9 vs 7 days, p<0.001)., Conclusions: Preoperative anemia is a significant risk factor for perioperative transfusion with significant increase in postoperative infectious complications and anastomotic complications after IPAA. Strategies to correct preoperative anemia, refine indications for transfusion, and define the use of blood salvage techniques may be helpful in decreasing this risk.

Objective: Using meta-analytical techniques, the study compared postoperative adverse events and functional outcomes of stapled versus hand-sewn ileal pouch-anal anastomosis (IPAA) following restorative proctocolectomy., Background: The choice of mucosectomy and hand-sewn versus stapled pouch-anal anastomosis has been a subject of debate with no clear consensus as to which method provides better functional results and long-term outcomes., Methods: Comparative studies published between 1988 and 2003, of hand-sewn versus stapled IPAA were included. Endpoints were classified into postoperative complications and functional and physiologic outcomes measured at least 3 months following closure of ileostomy or surgery if no proximal diversion was used, quality of life following surgery, and neoplastic transformation within the anal transition zone., Results: Twenty-one studies, consisting of 4183 patients (2699 hand-sewn and 1484 stapled IPAA) were included. There was no significant difference in the incidence of postoperative complications between the 2 groups. The incidence of nocturnal seepage and pad usage favored the stapled IPAA (odds ratio [OR] = 2.78, P < 0.001 and OR = 4.12, P = 0.007, respectively). The frequency of defecation was not significantly different between the 2 groups (P = 0.562), nor was the use of antidiarrheal medication (OR = 1.27, P = 0.422). Anorectal physiologic measurements demonstrated a significant reduction in the resting and squeeze pressure in the hand-sewn IPAA group by 13.4 and 14.4 mm Hg, respectively (P < 0.018). The stapled IPAA group showed a higher incidence of dysplasia in the anal transition zone that did not reach statistical significance (OR = 0.42, P = 0.080)., Conclusions: Both techniques had similar early postoperative outcomes; however, stapled IPAA offered improved nocturnal continence, which was reflected in higher anorectal physiologic measurements. A risk of increased incidence of dysplasia in the ATZ may exist in the stapled group that cannot be quantified by this study. We describe a decision algorithm for the choice of IPAA, based on the relative risk of long-term neoplastic transformation.

Background & Aims: Although pouchitis is considered the most common adverse sequela of ileal pouch-anal anastomosis (IPAA), inflammatory and noninflammatory conditions other than pouchitis are increasingly being recognized. The risk factors for these non-pouchitis conditions, including Crohn's disease (CD) of the pouch, cuffitis, and irritable pouch syndrome (IPS), have not been studied. The aim of this study was to assess risk factors for inflammatory and noninflammatory diseases of IPAA in a tertiary care setting., Methods: The study consisted of 240 consecutive patients who were classified as having healthy pouches (N = 49), pouchitis (N = 61), CD of the pouch (N = 39), cuffitis (N = 41), or IPS (N =50). Demographic and clinical features were assessed to determine risk factors for each of these conditions by using logistic regression analysis., Results: Risk factors remaining in the final logistic regression models were for pouchitis: IPAA indication for dysplasia (odds ratio [OR], 3.89; 95% confidence interval [CI], 1.69-8.98), never having smoked (OR, 5.09; 95% CI, 1.01-25.69), no use of anti-anxiety agents (OR, 5.19; 95% CI, 1.45-18.59), or use of NSAIDs (OR, 3.24; 95% CI, 1.71-6.13); for CD of the pouch: a long duration of IPAA (OR, 1.20; 95% CI, 1.12-1.30) and current smoking (OR, 4.77; 95% CI, 1.39-16.25); for cuffitis: arthralgias (OR, 4.13; 95% CI, 1.91-8.94) and younger age (OR, 1.16; 95% CI, 1.01-1.33); and for IPS: use of antidepressants (OR, 4.17, 95% CI, 1.95-8.92) or anti-anxiety agents (OR, 3.21; 95% CI, 1.34-7.47)., Conclusions: The majority of risk factors for the 4 inflammatory and noninflammatory conditions of IPAA are different, suggesting that each of these diseases has a different etiology and pathogenesis. The identification and modification of these risk factors might help patients and clinicians to make a preoperative decision for IPAA, reduce IPAA-related morbidity, and improve response to treatment.

Background: Management of antibiotic-dependent pouchitis is often challenging. Oral bacteriotherapy with probiotics (such as VSL #3) as maintenance treatment has been shown to be effective in relapsing pouchitis in European trials. However, this agent has not been studied in the US, and its applicability in routine clinical practice has not been evaluated., Aim: To determine compliance and efficacy of probiotic treatment in patients with antibiotic-dependent pouchitis., Methods: Thirty-one patients with antibiotic-dependent pouchitis were studied. VSL #3 is a patented probiotic preparation of live freeze-dried bacteria. All patients received 2 weeks of ciprofloxacin 500 mg b.d. followed by VSL #3 6 g/day for 8 months. Baseline Pouchitis Disease Activity Index scores were calculated. Patients' symptoms were reassessed at week 3 when VSL #3 therapy was initiated and at the end of the 8-month trial. Some patients underwent repeat pouch endoscopy at the end of the trial., Results: All 31 patients responded to the 2-week ciprofloxacin trial with resolution of symptoms and they were subsequently treated with VSL #3. The mean duration of follow-up was 14.5+/-5.3 months (range: 8-26 months). At the 8-month follow-up, six patients were still on VSL #3 therapy, and the remaining 25 patients had discontinued the therapy due to either recurrence of symptoms while on treatment or development of adverse effects. All six patients who completed the 8-month course with a mean treatment period of 14.3+/-7.2 months (range: 8-26 months) had repeat clinical and endoscopic evaluation as out-patients. At the end of 8 months, these six patients had a mean Pouchitis Disease Activity Index symptom score of 0.33+/-0.52 and a mean Pouchitis Disease Activity Index endoscopy score of 1.83+/-1.72, which was not statistically different from the baseline Pouchitis Disease Activity Index endoscopy score of 2.83+/-1.17 (P=0.27)., Conclusion: This study was conducted to evaluate bacteriotherapy in routine care. The use of probiotics has been adopted as part of our routine clinical practice with only anecdotal evidence of efficacy. Our review of patient outcome from the treatment placebo showed that only a minority of patients with antibiotic-dependent pouchitis remained on the probiotic therapy and in symptomatic remission after 8 months.

Objectives: The objectives of this study were to evaluate the effect of radiotherapy (RT) on sexual function in patients undergoing oncologic resection for rectal cancer, and to develop a mathematical model for quantifying the risk of sexual dysfunction through time for this group of patients., Methods: Data were prospectively collected on patients undergoing proctosigmoidectomy (group 1: n = 101) or adjuvant radiotherapy (40-50 Gy) and resection (group 2: n = 100) for rectal cancer at a tertiary referral center between December 1998 and July 2004. Study end points were recorded at 7 time intervals (preoperatively, 4 months, 8 months, 1 year, 2 years, 3 years, and 4 years after surgery) and included: 1) ability to have an erection, 2) maintain an erection, 3) attain orgasm, 4) dry orgasm, and 5) whether they were sexually active. Multilevel logistic regression analysis for repeated measures was used to identify factors associated with the sexual dysfunction. A predictive model was developed and internally validated by comparing observed and model-predicted outcomes., Results: Radiotherapy had an adverse effect on the ability to get an erection, maintain an erection, attain orgasm, and being sexually active in comparison with patients undergoing surgery alone (7.4%, 12.6%, 16.2%, and 13.7% reduction 8 months after surgery respectively; P < 0.05). The effect of sexual dysfunction deteriorated with age (odds ratio for erectile function, 0.40 per 10-year increase in age; 95% confidence interval, 0.29-0.49; P < 0.001). A significant variability in sexual function was present among the 7 time points with a maximal deterioration occurring at 8 months after surgery with subsequent slow but not complete recovery (P < 0.001). The predictive model showed adequate discrimination on 4 of the 5 domains of sexual dysfunction (area under the receiver operating characteristic curve >0.70)., Conclusions: Radiotherapy has an adverse effect on sexual function, the effect being maximal at 8 months after surgery. The risk of sexual dysfunction can be quantified preoperatively using the proposed index and can assist patients in making better informed choices on the type of treatment they receive.

Objective: To provide a multidimensional analysis of the learning curve in major laparoscopic colonic and rectal surgery and compare outcomes between right-sided versus left-sided resections., Summary Background Data: The laparoscopic learning curve is known to vary between surgeons, may be influenced by the patient selection and operative complexity, and requires appropriate case-mix adjustment., Methods: This is a descriptive single-center study using routinely collected clinical data from 900 patients undergoing laparoscopic surgery between November 1991 and April 2003. Outcome measures included operation time, conversion rate (CR), and readmission and postoperative complication rates. Multifactorial logistic regression analysis was used to identify patient-, surgeon-, and procedure-related factors associated with conversion of laparoscopic to open surgery. A risk-adjusted Cumulative Sum (CUSUM) model was used for evaluating the learning curve for right and left-sided resections., Results: The conversion rate for right-sided colonic resections was 8.1% (n = 457) compared with 15.3% for left-sided colorectal resections (n = 443). Independent predictors of conversion of laparoscopic to open surgery were the body mass index (BMI) (odds ratio [OR] = 1.07 per unit increase), ASA grade (OR = 1.63 per unit increase), type of resection (left colorectal versus right colonic procedures, OR = 1.5), presence of intra-abdominal abscess (OR = 5.0) or enteric fistula (OR = 4.6), and surgeon's experience (OR 0.9 per 10 additional cases performed). Having adjusted for case-mix, the CUSUM analysis demonstrated a learning curve of 55 cases for right-sided colonic resections versus 62 cases for left-sided resections. Median operative time declined with operative experience (P<0.001). Readmission rates and postoperative complications remained unchanged throughout the series and were not dependent on operative experience., Conclusions: Conversion rates for laparoscopic colectomy are dependent on a multitude of factors that require appropriate adjustment including the learning curve (operative experience) for individual surgeons. The laparoscopic model described can be used as the basis for performance monitoring between or within institutions.

Background: The formation of postoperative adhesions is a common problem in abdominal surgery that may lead to serious complications. Appropriate animal adhesion models are essential for the investigation of adhesiogenesis and the development of new anti-adhesive products. Although animal models have been developed to study the process of adhesion formation in the abdomen, they are not effective in generating adhesions located over small bowel where adhesions are most commonly observed in clinical practice., Methods: Twenty-nine Sprague Dawley rats were subjected to standardized cecal abrasion (group 1; n=9), or two types of multiple abrasion, in which cecal and 3 or 5 abrasions were performed on small bowel (group 2, n=10; and group 3, n=10). An observer blinded to the randomization assessed the difficulty of adhesiolysis on a 6-point scale, and the locations of the adhesions were recorded 21 days after the initial surgery., Results: Adhesiolysis was significantly more difficult in group 3 than in group 1 (p=0.01). The number of animals that had adhesions between the small bowel segments and the total number of locations where small bowel adhered were significantly greater in group 2 and 3 than in group 1 (p<0.05 for all comparisons)., Conclusions: Abrasions to the small bowel created consistent adhesions that have clinical characteristics of intra-abdominal adhesions as compared to the standard cecal abrasion model and that can be used in future animal studies on adhesions.

Summary Background Data: We define the learning curve required to attain satisfactory training in ileal pouch-anal anastomosis (IPAA) and identify possible differences in the learning curve for stapled and hand-sewn IPAA surgery. Various studies have addressed the differences in failure rate between stapled and hand-sewn IPAA, but there is no literature that evaluates the differences in attaining satisfactory training in each of these techniques., Methods: Data were collected from 1965 patients undergoing IPAA surgery by 12 surgeons in a single center between 1983 and 2001. Using ileoanal pouch failure as the primary end point, a parametric survival model was used to adjust for case mix (patient comorbidity, preoperative diagnosis, manometric findings, and prior anal pathology). A risk-adjusted cumulative sum (CUSUM) model was used for monitoring outcomes in IPAA surgery., Results: The 5-year ileal pouch survival was 95.6% (median patient follow-up of 4.2 years; range 0-19 years). Fifty percent of trainee staff demonstrated a learning curve in IPAA surgery. Having adjusted for case mix, trainee staff undertaking stapled IPAA surgery showed an improvement in the pouch failure rate following an initial training period of 23 cases versus 40 cases for senior staff. The learning curve for hand-sewn IPAA surgery was quantified only for senior staff who attained adequate results following an initial period of 31 procedures., Conclusions: The CUSUM method was a useful tool for objectively measuring performance during the learning phase of IPAA surgery. With adequate training, supervision, and monitoring, the learning curve in IPAA surgery may be reduced even further.

Background & Aims: Transmural inflammation, a distinguishing feature of Crohn's disease (CD), cannot be assessed by conventional colonoscopy with mucosal biopsy. Our previous ex vivo study of histology-correlated optical coherence tomography (OCT) imaging on colectomy specimens of CD and ulcerative colitis (UC) showed that disruption of the layered structure of colon wall on OCT is an accurate marker for transmural inflammation of CD. We performed an in vivo colonoscopic OCT in patients with a clinical diagnosis of CD or UC using the previously established, histology-correlated OCT imaging criterion., Methods: OCT was performed in 40 patients with CD (309 images) and 30 patients with UC (292 images). Corresponding endoscopic features of mucosal inflammation were documented. Two gastroenterologists blinded to endoscopic and clinical data scored the OCT images independently to assess the feature of disrupted layered structure., Results: Thirty-six CD patients (90.0%) had disrupted layered structure, whereas 5 UC patients (16.7%) had disrupted layered structure (P < .001). Using the clinical diagnosis of CD or UC as the gold standard, the disrupted layered structure on OCT indicative of transmural inflammation had a diagnostic sensitivity and specificity of 90.0% (95% CI: 78.0%, 96.5%) and 83.3% (95% CI: 67.3%, 93.3%) for CD, respectively. The kappa coefficient in the interpretation of OCT images was 0.80 (95% CI: 0.75, 0.86, P < .001)., Conclusions: In vivo colonoscopic OCT is feasible and accurate to detect disrupted layered structure of the colon wall indicative of transmural inflammation, providing a valuable tool to distinguish CD from UC.

Objective: Recent experience with surgery for enterocutaneous fistulae (ECF) at a specialist colorectal unit is reviewed to define factors relating to a successful surgical outcome., Summary Background Data: ECF cause significant morbidity and mortality and need experienced surgical management. Previous publications have concentrated on mortality resulting from fistulae, while factors affecting recurrence have not previously been a focus of analysis., Methods: Records were reviewed of patients who had ECF surgery (1994-2001). Management strategy involved early drainage of sepsis and nutritional support prior to elective ECF repair, with selective defunctioning proximal stoma formation., Results: A total of 205 patients were available (89 males, 43%; median age, 51 years; range, 16-86) years). ECF were related to Crohn's disease in 95, ulcerative colitis in 18, diverticular disease in 17, carcinoma in 25 (16 after radiotherapy), mesh ventral hernia repair in 21, and other causes in 29. Forty-one (20%) had undergone attempted fistula repair at other institutions. Initial management included CT-guided drainage of an intra-abdominal abscess in 23 patients, and total parenteral nutrition in 74 (36%). A total of 203 patients had definitive ECF repair. Forty-four had oversewing or wedge resection of the fistula, and 159 had resection and reanastomosis of the involved small bowel segment or ileocolic anastomosis. Ninety-day operative mortality was 3.5%. A total of 42 (20.5%) patients developed ECF recurrence within 3 months. Multivariate analysis demonstrated that recurrence was more likely after oversewing (36%) than resection (16%, P = 0.006)., Conclusions: A strategy of drainage of acute sepsis, maintenance of nutritional support prior to surgery, and selective use of PS allows for primary closure in 80% of complicated ECF. Resection should be performed when feasible.

Background and Aims: Distinguishing Crohn's disease (CD) from ulcerative colitis (UC) can be difficult. Transmural inflammation, a key feature of CD, cannot be assessed by conventional colonoscopy with biopsy. Optical coherence tomography (OCT) provides high-resolution, cross-sectional images of the gut wall and might become a new diagnostic tool. The aims of this study were to perform histology-correlated OCT on surgical specimens of CD and UC and to determine its diagnostic accuracy., Methods: Colectomy specimens from patients with a preoperative diagnosis of CD (N = 24) or UC (N = 24) were studied with OCT in the operating room. OCT and histopathology were assessed blindly, and diagnostic accuracy of OCT was assessed., Results: Eight preoperatively identified UC patients (33%) with transmural inflammation on postoperative histology were diagnosed with CD, and all 8 had a disrupted layered structure on OCT, a characteristic feature of transmural disease. Sixteen UC patients (67%) had superficial inflammation on histology; of them, 13 (81%) had an intact layered structure on OCT. All 24 preoperative CD patients had transmural inflammation on histology, and 23 (96%) had a disrupted layered structure on OCT. Of 585 histology-OCT image sets from the 48 patients, 152 sets (26%) had transmural inflammation on histology. The sensitivity and specificity for OCT to detect transmural disease were 86% and 91%, respectively., Conclusions: Transmural inflammation, as characterized by disruption of the layered structure of colon wall on OCT, is an accurate marker for the diagnosis of CD. Ex vivo OCT predicted transmural inflammation on postoperative histopathology.

Background & Aims: Some patients who undergo ileal pouch-anal anastomosis (IPAA) surgery for ulcerative colitis (UC) or indeterminate colitis are subsequently diagnosed with Crohn's disease (CD). Making the diagnosis of CD in patients with IPAA can be difficult, but it is important for prognostic and therapeutic purposes. The aim of this study was to identify diagnostic features of CD in patients with IPAA., Methods: We evaluated 87 patients who had undergone IPAA for inflammatory bowel disease. Patients were classified as having UC (n = 28), CD (n = 27), or indeterminate colitis (n = 32) based on review of the original colectomy pathology and the postoperative clinical course. Each patient underwent a pouch endoscopy with biopsies of the pouch and afferent limb. Both the endoscopist and pathologist were blinded to the patient's diagnosis., Results: Afferent limb ulcers (ALUs) were seen on endoscopy in 12 of 27 patients with CD (45%) and 4 of 28 patients with UC (14%) (P = 0.019). After excluding patients who had taken nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month, ALUs were found in 7 of 18 patients with CD (39%) and 0 of 17 patients with UC (P = 0.010). Controlling for NSAID use and smoking, the odds ratio for ALUs indicating CD was 4.67 (P = 0.03). In the UC population, ALUs were seen in 4 of 11 patients (36%) who had taken NSAIDs in the past month and 0 of 17 patients who had not taken NSAIDs (P = 0.016)., Conclusions: ALUs seen on endoscopy are suggestive of CD in patients with inflammatory bowel disease who are not taking NSAIDs.

Background & Aims: Increased stool frequency, urgency, and abdominal pain in patients with ileal pouch-anal anastomosis (IPAA) may be due to inflammatory conditions, including pouchitis, cuffitis, or Crohn's disease or noninflammatory conditions such as irritable pouch syndrome. Distinction among these entities requires pouch endoscopy and biopsy. Noninvasive means of diagnosis are preferable., Methods: Sixty consecutive subjects with IPAA for inflammatory bowel disease had measurements of fecal lactoferrin and alpha1-antitrypsin and underwent pouch endoscopy with biopsy, with calculation of the pouchitis disease activity index in a prospective cross-sectional study., Results: Symptomatic patients with an inflammatory condition had significantly higher fecal lactoferrin concentrations (median, 176.0 microg/mL, interquartile range [IQR] 79.0-450.8) compared with those with a noninflammatory condition (median, 4.8 microg/mL; IQR, 1.2-11.0) or those who were asymptomatic (median, 7.8 microg/mL; IQR, 1.4-12.9), P < 0.001. At a cutoff level of 7 microg/mL, fecal lactoferrin could distinguish patients with irritable pouch syndrome from those with pouchitis, cuffitis, or Crohn's disease with a sensitivity of 100% and specificity of 85%. Fecal alpha1-antitrypsin was not able to distinguish symptomatic patients with and without an inflammatory condition., Conclusions: Fecal lactoferrin can serve as a sensitive and noninvasive initial screening test in an algorithm for evaluation of symptomatic patients with IPAA. If fecal lactoferrin levels are low (<7 microg/mL), IPS can be diagnosed. If fecal lactoferrin levels are high, pouch endoscopy with biopsy is warranted to distinguish among different causes of inflammation. Longitudinal studies are needed to define better the role of this test in the management of patients with IPAA.

Background and Aims: Postoperative adhesions mostly cleave to small bowel and lead to troublesome problems. This study evaluated the effectiveness of a novel liquid antiadhesive product (Adcon-P) in rats., Subjects and Methods: Thirty-eight Sprague Dawley rats underwent laparotomy during which the surgeon created abrasions on five different small bowel locations and the cecum in order to generate adhesions. Rats were randomly assigned to receive Adcon-P ( n=19) or to a control group ( n=19). The animals were killed on postoperative day 21. An observer blinded to the randomization assessed the difficulty of adhesiolysis with a six-point scoring system, recorded locations of adhesions and, noted the presence of serosal and full-thickness injuries. The total number of adhesions was also chronicled., Results: The severity of adhesion and adhesion scores were significantly lower in animals receiving Adcon-P. More animals suffered full-thickness and serosal injuries in the control group. The adhesions between small bowel segments and the number of adhesions attached to the small bowel were significantly lower in animals that received Adcon-P., Conclusion: Adcon-P leads to an easier adhesiolysis and lessens the risk of bowel injury during relaparotomy. In particular, Adcon-P reduces the probability that adhesions specifically attach to the small bowel.

Objective: To identify risk factors associated with ileal pouch failure and to develop a multifactorial model for quantifying the risk of failure in individual patients. SUMMARY BACKGROUND DATA Ileal pouch anal anastomosis (IPAA) has become the treatment choice for most patients with ulcerative colitis and familial adenomatous polyposis who require surgery. At present, there are no published studies that investigate collectively the interrelation of factors related to ileal pouch failure, nor are there any predictive indices for risk stratification of patients undergoing IPAA surgery., Methods: Data from 23 preoperative, 7 intraoperative, and 10 postoperative risk factors were recorded from 1,965 patients undergoing restorative proctocolectomy in a single center between 1983 and 2001. Primary end point was ileal pouch failure during the follow-up period of up to 19 years. The "CCF ileal pouch failure" model was developed using a parametric survival analysis and a 70%:30% split-sample validation technique for model training and testing., Results: The median patient follow-up was 4.1 year (range, 0-19 years). Five-year ileal pouch survival was 95.6% (95% CI, 94.4-96.7). The following risk factors were found to be independent predictors of pouch survival and were used in the final multivariate model: patient diagnosis, prior anal pathology, abnormal anal manometry, patient comorbidity, pouch-perineal or pouch-vaginal fistulae, pelvic sepsis, anastomotic stricture and separation. The model accurately predicted the risk of ileal pouch failure with adequate calibration statistics (Hosmer Lemeshow chi2 = 3.001; P = 0.557) and an area under the receiver operating characteristics curve of 82.0%., Conclusions: The CCF ileal pouch failure model is a simple and accurate way of predicting the risk of ileal pouch failure in clinical practice on a longitudinal basis. It may play an important role in providing risk estimates for patients wishing to make informed choices on the type of treatment offered to them.

OBJECTIVE To evaluate how age affects functional outcome and quality of life after ileal pouch anal anastomosis (IPAA). SUMMARY BACKGROUND DATA Because of the limited number of older patients undergoing IPAA, it has been difficult to assess functional outcome and quality of life stratified by age. METHODS IPAA was performed in 1895 patients. Patients were stratified by age into <45 (n = 1410), 46-55 (n = 289), 56-65 (n = 154), and more than 65 years (n = 42). Outcome was assessed prospectively. Results are presented at 1, 3, 5, and 10 years after surgery.RESULTS Patients were followed for 4.6 +/- 3.7 years (maximum, 17 years). Pouch failure occurred in 4.1% (pouch excision or permanent diversion). Incontinence and night time seepage were more common in older patients. There were minor differences in the quality of life, health, energy and happiness between age groups, with a slight benefit for those under 45 years. Fourteen percent or fewer patients experienced social, sexual or work restrictions. Overall, 96% of patients were happy to have undergone their surgery, and 98% recommended it to others. Although the respective figures were 89% and 96% in the over-65 age group, the difference was not significant. CONCLUSIONS These data provide a unique assessment of outcome after IPAA at multiple time points. Although functional outcome after IPAA is not as good in older patients, appropriate case selection confers acceptable function and quality of life to patients of all ages.

Objective: Comparison of outcome and costs after laparoscopic and open colectomy., Summary Background Data: Previous studies comparing laparoscopic and open colectomy report conflicting results with regard to clinical outcome and costs., Methods: Laparoscopic colectomy patients from a prospective database were matched for age, gender, and disease-related grouping to patients who underwent the same operation by the open approach over the same period (2000 to 2001). Data for the latter group was gathered by retrospective analysis and the 2 groups were compared for outcome and direct costs., Results: Laparoscopic colectomy patients (n = 150) were compared with the same number of open colectomy patients. American Society of Anesthesiologists classification (P = 0.09), body mass index (P = 0.17), diagnosis (P = 0.12), complications (P = 0.14), and rate of readmission within 30 days (P = 0.44) were similar for both groups. Operating room costs were significantly higher after laparoscopic colectomy (P < 0.0001), but length of hospital stay was significantly lower (P < 0.0001). This resulted in significantly lower total costs (P = 0.0007) owing to lower pharmacy (P < 0.0001), laboratory (P <0.0001), and ward nursing costs (P = 0.0004)., Conclusions: Laparoscopic colectomy results in significantly lower direct costs compared with open colectomy for carefully matched patients.

Background and Aims: Because of improved medical care and surgical techniques blow-hole colostomy with loop ileostomy is now rarely performed to reduce operative risks in patients with toxic megacolon related to inflammatory bowel disease (IBD). We reviewed patient charts to identify continuing indications for this procedure., Patients and Methods: Seventeen patients underwent blow-hole colostomy procedure with ( n=15) or without ( n=2) ileostomy (8 men, 9 women; median age 51 years, range 21-79) during the past 18 years (1983-2001)., Results: The indications for the procedure were: toxic megacolon related to IBD ( n=6), toxic megacolon related to IBD and associated with pregnancy ( n=2), Clostridium difficile colitis ( n=3), adult Hirschsprung's disease ( n=1), pancreatitis with obstructing pseudocyst ( n=1), and palliation for malignant bowel obstruction with metastases ( n=4). Patients were discharged home after a median stay of 10 days (range 4-32 days). The 4 patients who underwent a palliative blow-hole procedure had died secondary to their underlying disease by the time of follow-up. Of the remaining 13 patients 12 had their alimentary tract reconstituted, and one still awaits a definitive procedure., Conclusion: The blow-hole colostomy-ileostomy procedure is still indicated for select patients with toxic megacolon and large-bowel obstruction. The procedure acts as a bridge to definitive operation for toxic patients with benign disease and palliates those with malignant obstructions and metastasis.

Background and Aims: Peutz-Jeghers syndrome (PJS) is a rare, autosomal-dominant disease characterized by hamartomatous polyps of the alimentary tract, hyperpigmentation of the skin, and family history of PJS. Rarely, solitary Peutz-Jeghers polyps (PJP) arise in patients without other features of PJS., Patients and Methods: We reviewed eight patients since 1979 with solitary PJP, six men and two women., Results: The average age at diagnosis was higher (56+/-13 years) than that of PJS patients in the literature. Polyps were found in the sigmoid colon ( n=4), cecum ( n=1), stomach ( n=1), and duodenum ( n=2). The colonic polyps were diagnosed and removed endoscopically. Indications for colonoscopy included routine screening ( n=4) or rectal bleeding ( n=1). The duodenal and gastric polyps were diagnosed and removed during gastroduodenoscopic examinations, which were performed for nonspecific dyspepsia ( n=2) or gastrointestinal bleeding ( n=1). The median size was 20 mm (range 2 mm-25 mm). Patients were followed for a median of 11.5 years (range 3-22) without another PJP or cancer. Three patients died of causes unrelated to PJP. Five patients are alive and polyp free., Conclusion: Solitary PJP do not carry a risk of gastrointestinal cancer and are not an indication for specific high-risk screening.

Objective: To examine the effect of preoperative radiotherapy (PRT) on patients who undergo rectal resection with total mesorectal excision (TME) for stage T3 low rectal cancers., Summary Background Data: Evidence for the value of PRT before rectal cancer surgery is weakened by variability in the use of TME. Many surgeons have concluded that PRT is unnecessary for small rectal tumors if TME is performed, but there are no prospective data to support this opinion., Methods: Since 1980, 2,200 patients with rectal cancer have been enrolled in a prospective database. Of these, 259 underwent curative anterior or abdominoperineal resection with TME for pathologically confirmed T3 lesions within 8 cm of the anal verge. Patients were grouped by receiving PRT (n = 92) or not receiving PRT (n = 167). Five-year overall survival and 5-year local recurrence rates were evaluated., Results: Overall survival was increased from 52% in patients not receiving PRT to 63% in those receiving PRT. PRT increased overall survival for node-negative patients from 58% to 82%, with no benefit for node-positive patients. There was no significant difference in local recurrence rates. When categorized by tumor size, there was no difference in overall survival or local recurrence for 0- to 2-cm tumors or those larger than 5 cm, but PRT increased overall survival from 50% to 72% for patients with 2- to 5-cm tumors. Similar results were observed for patients with tumors staged as T3 on preoperative endoluminal ultrasound., Conclusions: Patients with pT3 low rectal cancers undergoing resection with TME have an improved survival with PRT. The effect is most beneficial for patients with node-negative and 2- to 5-cm tumors, although this group may include larger and node-positive tumors that have been downstaged by PRT. PRT should be advocated for all patients with T3 rectal cancers less than 8 cm from the anal verge, even if the surgery includes a properly performed TME.

Objective: To compare the function, complications, and quality of life after ileal pouch-anal anastomosis (IPAA) for patients with indeterminate colitis (IndC) and ulcerative colitis (UC)., Summary Background Data: Reports on the outcome of IPAA for IndC have been inconclusive because of the small numbers available for analysis. Concerns about functional outcome, infectious perineal complications, pouch loss and the development of Crohn's disease remain, while there is no data on the quality of life after IPAA for IndC., Methods: One thousand nine hundred and eleven patients undergoing IPAA for Ind and UC from 1983 to 1999 were evaluated. IndC was confirmed by repeat pathologic evaluation in 115 patients. Functional outcome and quality of life were assessed prospectively for all office visits (IndC = 230; UC = 5388) using previously reported systems. Complications were evaluated retrospectively., Results: Functional results and the incidence of anastomotic complications and major pouch fistulae were the same in UC and IndC patients. Although IndC patients were more likely to develop minor perineal fistulae, pelvic abscess, and Crohn's disease, the rate of pouch failure was 3.4%, identical to that of UC patients. There was no clinically significant difference in quality of life, or satisfaction with IPAA surgery. Patients were equally happy to recommend surgery to IndC or UC patients, but 3% fewer IndC would undergo the same surgery again for their disease., Conclusions: While functional outcome, quality of life, and pouch survival rates are equivalent after IPAA for IndC and UC, there is an increase in some complications and the late diagnosis of Crohn's disease. Over 93% of IndC patients would undergo the same procedure again, and 98% would recommend IPAA to others with IndC. Patients with IndC should not be precluded from having IPAA surgery.

Background & Aims: Pouchitis often is diagnosed based on symptoms alone. In this study, we evaluate whether symptoms correlate with endoscopic and histologic findings in patients with ulcerative colitis and an ileal pouch-anal anastomosis., Methods: Symptoms, endoscopy, and histology were assessed in 46 patients using Pouchitis Disease Activity Index (PDAI). Patients were classified as either having pouchitis (PDAI score > or =7; N = 22) or as not having pouchitis (PDAI score <7; N = 24)., Results: Patients with pouchitis had significantly higher mean total PDAI scores, symptom scores, endoscopy scores, and histology scores. There was a similar magnitude of contribution of each component score to the total PDAI for the pouchitis group. Of note, 25% of patients with symptoms suggestive of pouchitis did not meet the PDAI diagnostic criteria for pouchitis. In both groups, the correlation coefficients between symptom, endoscopy, and histology scores were near zero (range, -0.26 to 0.20; P > 0.05)., Conclusions: The symptom, endoscopy, and histology scores each contribute to the PDAI and appear to be independent of each other. Symptoms alone do not reliably diagnose pouchitis.

Objective: To evaluate prospectively long-term quality of life and functional outcome after restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis, and to evaluate and validate a novel quality-of-life indicator in this group of patients., Summary Background Data: Restorative proctocolectomy with ileal pouch-anal anastomosis is now the preferred option when total proctocolectomy is required for ulcerative colitis or familial adenomatous polyposis, but long-term data on functional outcome and quality of life after the procedure are lacking., Methods: Patients (n = 977) who underwent RPC with stapled anastomosis for colitis or polyposis coli and who were followed for > or =12 months were included. Quality of life, fecal incontinence, and satisfaction with surgery were prospectively evaluated by structured interview or questionnaire for 1 to 12 years after surgery (median 5.0). Quality of life was scored using the Cleveland Global Quality of Life (CGQL) instrument (Fazio Score). This is a novel score developed over the past 15 years by the senior author. Quality of life was also evaluated in a subgroup of patients with the Short Form 36 (SF-36). The CGQL was validated by determining its reliability, responsiveness, and validity as well as its correlation with the SF-36 score., Results: Postoperative quality of life as measured by SF-36 was excellent and compared well with published norms for the general U.S. population. The CGQL was found to be reliable, responsive, and valid, and there was a high correlation with the SF-36 scores. Using the CGQL, quality of life was shown to increase after the first 2 years after surgery, and there was no deterioration thereafter. The prevalence of perfect continence increased from 75.5% before surgery to 82.4% after surgery, and although this deteriorated somewhat >2 years after surgery, it was no worse than preoperative values. Ninety-eight percent of patients would recommend the surgery to others., Conclusions: Long-term quality of life after ileal pouch surgery is excellent and the level of continence is satisfactory. This surgery is an excellent long-term option in patients requiring total proctocolectomy. The CGQL is a simple, valid, and reliable measure of quality of life after pelvic pouch surgery and may well be applicable in many other clinical conditions.

Objective: To evaluate the outcome of repeat ileal pouch-anal anastomosis (IPAA) for septic complications of pelvic pouch surgery; to assess the relationship between diagnosis and outcome; to assess quality of life after surgery., Summary Background Data: Pelvic and perineal sepsis due to ileal pouch-anal anastomotic leaks frequently results in pouch loss. Many surgeons believe that pelvic sepsis and/or dense pelvic fibrosis makes salvage surgery unsafe or that pouches salvaged under these circumstances may not function well. As a result, there are few studies of pouch salvage procedures for septic indications., Methods: The authors reviewed records of Cleveland Clinic Foundation patients who had undergone repeat IPAA surgery after septic complications from previous pelvic pouch surgery and who had completed at least 6 months of follow-up. Final diagnoses included ulcerative colitis (n = 22), Crohn's disease (n = 10), indeterminate colitis (n = 1), and familial polyposis (n = 2). Patients with functioning pouches were interviewed about functional problems and quality of life using an in-house questionnaire and the validated SF-36 Health Survey., Results: Of 35 patients, 30 (86%) had a functioning pouch 6 months after repeat IPAA. In 4 patients, complications led to pouch removal or fecal diversion. One patient declined stoma closure. Of the patients with mucosal ulcerative colitis (MUC), 95% (21/22) had a functioning pouch 6 months after surgery. For patients with Crohn's disease (CD) 60% (6/10) have maintained a functioning pouch. Of the 30 patients with functioning pouches, 17 (57%) rated their quality of life as either "good" or "excellent," the remaining 13 (43%) selected "fair" or "poor." All said they would choose repeat IPAA surgery again. An SF-36 Health Survey completed by all patients with a functioning pouch at follow-up showed a mean physical component scale of 46.4 and a mean mental component scale of 47.6, scores well within the normal limit., Conclusions: Repeat IPAA can often salvage pelvic pouches in patients with MUC who suffer major chronic perianastomotic and pelvic sepsis. Patients who had successful repeat IPAA surgery often report functional problems but would still choose to have the surgery again. For patients with CD, ultimate pouch excision or fecal diversion have been required in 40% indicating a guarded prognosis for these patients. Data on the success of the procedure for patients with indeterminate colitis and familial adenomatous polyposis were inconclusive because of small sample sizes.